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Neonatal sepsis morbidity and mortality high across rich and poor countries

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Tue, 05/03/2022 - 14:34

LISBON – A shift toward broader-spectrum antibiotics and increasing antibiotic resistance has led to high levels of mortality and neurodevelopmental impacts in surviving babies, according to a large international study conducted on four continents.

Results of the 3-year study were presented at this week’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

The observational study, NeoOBS, conducted by the Global Antibiotic Research and Development Partnership (GARDP) and key partners from 2018 to 2020, explored the outcomes of more than 3,200 newborns, finding an overall mortality of 11% in those with suspected neonatal sepsis. The mortality rate increased to 18% in newborns in whom a pathogen was detected in blood culture.

More than half of infection-related deaths (59%) were due to hospital-acquired infections. Klebsiella pneumoniae was the most common pathogen isolated and is usually associated with hospital-acquired infections, which are increasingly resistant to existing antibiotic treatments, said a report produced by GARDP to accompany the results.

The study also identified a worrying trend: Hospitals are frequently using last-line agents such as carbapenems because of the high degree of antibiotic resistance in their facilities. Of note, 15% of babies with neonatal sepsis were given last-line antibiotics.

Pediatrician Julia Bielicki, MD, PhD, senior lecturer, Paediatric Infectious Diseases Research Group, St. George’s University of London, and clinician at the University of Basel Children’s Hospital, Switzerland, was a coinvestigator on the NeoOBS study.

In an interview, she explained that, as well as reducing mortality, the research is about managing infections better to prevent long-term events and improve the quality of life for survivors of neonatal sepsis. “It can have life-changing impacts for so many babies,” Dr. Bielicki said. “Improving care is much more than just making sure the baby survives the episode of sepsis – it’s about ensuring these babies can become children and adults and go on to lead productive lives.”

Also, only a minority of patients (13%) received the World Health Organization guidelines for standard of care use of ampicillin and gentamicin, and there was increasing use of last-line agents such as carbapenems and even polymyxins in some settings in low- and middle-income countries. “This is alarming and foretells the impending crisis of a lack of antibiotics to treat sepsis caused by multidrug-resistant organisms,” according to the GARDP report.

There was wide variability in antibiotic combinations used across sites in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Uganda, and Vietnam, and often such use was not supported by underlying data.

Dr. Bielicki remarked that there was a shift toward broad-spectrum antibiotic use. “In a high-income country, you have more restrictive patterns of antibiotic use, but it isn’t necessarily less antibiotic exposure of neonates to antibiotics, but on the whole, usually narrow-spectrum agents are used.”

In Africa and Asia, on the other hand, clinicians often have to use a broader-spectrum antibiotic empirically and may need to switch to another antibiotic very quickly. “Sometimes alternatives are not available,” she pointed out.

“Local physicians are very perceptive of this problem of antibiotic resistance in their daily practice, especially in centers with high mortality,” said Dr. Bielicki, emphasizing that it is not their fault, but is “due to the limitations in terms of the weapons available to treat these babies, which strongly demonstrates the growing problem of antimicrobial resistance affecting these babies on a global scale.”

Tim Jinks, PhD, Head of Drug Resistant Infections Priority Program at Wellcome Trust, commented on the study in a series of text messages to this news organization. “This research provides further demonstration of the urgent need for improved treatment of newborns suffering with sepsis and particularly the requirement for new antibiotics that overcome the burden of drug-resistant infections caused by [antimicrobial resistance].”

“The study is a hugely important contribution to our understanding of the burden of neonatal sepsis in low- and middle- income countries,” he added, “and points toward ways that patient treatment can be improved to save more lives.”
 

 

 

High-, middle-, and low-income countries

The NeoOBS study gathered data from 19 hospitals in 11 high-, middle-, and low-income countries and assessed which antibiotics are currently being used to treat neonatal sepsis, as well as the degree of drug resistance associated with them. Sites included some in Italy and Greece, where most of the neonatal sepsis data currently originate, and this helped to anchor the data, Dr. Bielicki said.

The study identified babies with clinical sepsis over a 4-week period and observed how these patients were managed, particularly with respect to antibiotics, as well as outcomes including whether they recovered, remained in hospital, or died. Investigators obtained bacterial cultures from the patients and grew them to identify which organisms were causing the sepsis.

Of note, mortality varied widely between hospitals, ranging from 1% to 27%. Dr. Bielicki explained that the investigators were currently exploring the reasons behind this wide range of mortality. “There are lots of possible reasons for this, including structural factors such as how care is delivered, which is complex to measure,” she said. “It isn’t trivial to measure why, in a certain setting, mortality is low and why in another setting of comparable income range, mortality is much higher.”

Aside from the mortality results, Dr. Bielicki also emphasized that the survivors of neonatal sepsis frequently experience neurodevelopmental impacts. “A hospital may have low mortality, but many of these babies may have neurodevelopment problems, and this has a long-term impact.”

“Even though mortality might be low in a certain hospital, it might not be low in terms of morbidity,” she added.

The researchers also collected isolates from the cohort of neonates to determine which antibiotic combinations work against the pathogens. “This will help us define what sort of antibiotic regimen warrants further investigation,” Dr. Bielicki said.

Principal Investigator, Mike Sharland, MD, also from St. George’s, University of London, who is also the Antimicrobial Resistance Program Lead at Penta Child Health Research, said, in a press release, that the study had shown that antibiotic resistance is now one of the major threats to neonatal health globally. “There are virtually no studies underway on developing novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections.”

“This is a major problem for babies in all countries, both rich and poor,” he stressed.
 

NeoSep-1 trial to compare multiple different treatments

The results have paved the way for a major new global trial of multiple established and new antibiotics with the goal of reducing mortality from neonatal sepsis – the NeoSep1 trial.

“This is a randomized trial with a specific design that allows us to rank different treatments against each other in terms of effectiveness, safety, and costs,” Dr. Bielicki explained.

Among the antibiotics in the study are amikacin, flomoxef and amikacin, or fosfomycin and flomoxef in babies with sepsis 28 days old or younger. Similar to the NeoOBS study, patients will be recruited from all over the world, and in particular from low- and middle-income countries such as Kenya, South Africa, and other countries in Africa and Southeast Asia.

Ultimately, the researchers want to identify modifiable risk factors and enact change in practice. But Dr. Bielicki was quick to point out that it was difficult to disentangle those factors that can easily be changed. “Some can be changed in theory, but in practice it is actually difficult to change them. One modifiable risk factor that can be changed is probably infection control, so when resistant bacteria appear in a unit, we need to ensure that there is no or minimal transmission between babies.”

Luregn Schlapbach, MD, PhD, Head, department of intensive care and neonatology, University Children’s Hospital Zurich, Switzerland, welcomed the study, saying recent recognition of pediatric and neonatal sepsis was an urgent problem worldwide.

She referred to the 2017 WHO resolution recognizing that sepsis represents a leading cause of mortality and morbidity worldwide, affecting patients of all ages, across all continents and health care systems but that many were pediatric. “At that time, our understanding of the true burden of sepsis was limited, as was our knowledge of current epidemiology,” she said in an email interview. “The Global Burden of Disease study in 2020 revealed that about half of the approximatively 50 million global sepsis cases affect pediatric age groups, many of those during neonatal age.”

The formal acknowledgment of this extensive need emphasizes the “urgency to design preventive and therapeutic interventions to reduce this devastating burden,” Dr. Schlapbach said. “In this context, the work led by GARDP is of great importance – it is designed to improve our understanding of current practice, risk factors, and burden of neonatal sepsis across low- to middle-income settings and is essential to design adequately powered trials testing interventions such as antimicrobials to improve patient outcomes and reduce the further emergence of antimicrobial resistance.”

Dr. Bielicki and Dr. Schlapbach have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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LISBON – A shift toward broader-spectrum antibiotics and increasing antibiotic resistance has led to high levels of mortality and neurodevelopmental impacts in surviving babies, according to a large international study conducted on four continents.

Results of the 3-year study were presented at this week’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

The observational study, NeoOBS, conducted by the Global Antibiotic Research and Development Partnership (GARDP) and key partners from 2018 to 2020, explored the outcomes of more than 3,200 newborns, finding an overall mortality of 11% in those with suspected neonatal sepsis. The mortality rate increased to 18% in newborns in whom a pathogen was detected in blood culture.

More than half of infection-related deaths (59%) were due to hospital-acquired infections. Klebsiella pneumoniae was the most common pathogen isolated and is usually associated with hospital-acquired infections, which are increasingly resistant to existing antibiotic treatments, said a report produced by GARDP to accompany the results.

The study also identified a worrying trend: Hospitals are frequently using last-line agents such as carbapenems because of the high degree of antibiotic resistance in their facilities. Of note, 15% of babies with neonatal sepsis were given last-line antibiotics.

Pediatrician Julia Bielicki, MD, PhD, senior lecturer, Paediatric Infectious Diseases Research Group, St. George’s University of London, and clinician at the University of Basel Children’s Hospital, Switzerland, was a coinvestigator on the NeoOBS study.

In an interview, she explained that, as well as reducing mortality, the research is about managing infections better to prevent long-term events and improve the quality of life for survivors of neonatal sepsis. “It can have life-changing impacts for so many babies,” Dr. Bielicki said. “Improving care is much more than just making sure the baby survives the episode of sepsis – it’s about ensuring these babies can become children and adults and go on to lead productive lives.”

Also, only a minority of patients (13%) received the World Health Organization guidelines for standard of care use of ampicillin and gentamicin, and there was increasing use of last-line agents such as carbapenems and even polymyxins in some settings in low- and middle-income countries. “This is alarming and foretells the impending crisis of a lack of antibiotics to treat sepsis caused by multidrug-resistant organisms,” according to the GARDP report.

There was wide variability in antibiotic combinations used across sites in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Uganda, and Vietnam, and often such use was not supported by underlying data.

Dr. Bielicki remarked that there was a shift toward broad-spectrum antibiotic use. “In a high-income country, you have more restrictive patterns of antibiotic use, but it isn’t necessarily less antibiotic exposure of neonates to antibiotics, but on the whole, usually narrow-spectrum agents are used.”

In Africa and Asia, on the other hand, clinicians often have to use a broader-spectrum antibiotic empirically and may need to switch to another antibiotic very quickly. “Sometimes alternatives are not available,” she pointed out.

“Local physicians are very perceptive of this problem of antibiotic resistance in their daily practice, especially in centers with high mortality,” said Dr. Bielicki, emphasizing that it is not their fault, but is “due to the limitations in terms of the weapons available to treat these babies, which strongly demonstrates the growing problem of antimicrobial resistance affecting these babies on a global scale.”

Tim Jinks, PhD, Head of Drug Resistant Infections Priority Program at Wellcome Trust, commented on the study in a series of text messages to this news organization. “This research provides further demonstration of the urgent need for improved treatment of newborns suffering with sepsis and particularly the requirement for new antibiotics that overcome the burden of drug-resistant infections caused by [antimicrobial resistance].”

“The study is a hugely important contribution to our understanding of the burden of neonatal sepsis in low- and middle- income countries,” he added, “and points toward ways that patient treatment can be improved to save more lives.”
 

 

 

High-, middle-, and low-income countries

The NeoOBS study gathered data from 19 hospitals in 11 high-, middle-, and low-income countries and assessed which antibiotics are currently being used to treat neonatal sepsis, as well as the degree of drug resistance associated with them. Sites included some in Italy and Greece, where most of the neonatal sepsis data currently originate, and this helped to anchor the data, Dr. Bielicki said.

The study identified babies with clinical sepsis over a 4-week period and observed how these patients were managed, particularly with respect to antibiotics, as well as outcomes including whether they recovered, remained in hospital, or died. Investigators obtained bacterial cultures from the patients and grew them to identify which organisms were causing the sepsis.

Of note, mortality varied widely between hospitals, ranging from 1% to 27%. Dr. Bielicki explained that the investigators were currently exploring the reasons behind this wide range of mortality. “There are lots of possible reasons for this, including structural factors such as how care is delivered, which is complex to measure,” she said. “It isn’t trivial to measure why, in a certain setting, mortality is low and why in another setting of comparable income range, mortality is much higher.”

Aside from the mortality results, Dr. Bielicki also emphasized that the survivors of neonatal sepsis frequently experience neurodevelopmental impacts. “A hospital may have low mortality, but many of these babies may have neurodevelopment problems, and this has a long-term impact.”

“Even though mortality might be low in a certain hospital, it might not be low in terms of morbidity,” she added.

The researchers also collected isolates from the cohort of neonates to determine which antibiotic combinations work against the pathogens. “This will help us define what sort of antibiotic regimen warrants further investigation,” Dr. Bielicki said.

Principal Investigator, Mike Sharland, MD, also from St. George’s, University of London, who is also the Antimicrobial Resistance Program Lead at Penta Child Health Research, said, in a press release, that the study had shown that antibiotic resistance is now one of the major threats to neonatal health globally. “There are virtually no studies underway on developing novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections.”

“This is a major problem for babies in all countries, both rich and poor,” he stressed.
 

NeoSep-1 trial to compare multiple different treatments

The results have paved the way for a major new global trial of multiple established and new antibiotics with the goal of reducing mortality from neonatal sepsis – the NeoSep1 trial.

“This is a randomized trial with a specific design that allows us to rank different treatments against each other in terms of effectiveness, safety, and costs,” Dr. Bielicki explained.

Among the antibiotics in the study are amikacin, flomoxef and amikacin, or fosfomycin and flomoxef in babies with sepsis 28 days old or younger. Similar to the NeoOBS study, patients will be recruited from all over the world, and in particular from low- and middle-income countries such as Kenya, South Africa, and other countries in Africa and Southeast Asia.

Ultimately, the researchers want to identify modifiable risk factors and enact change in practice. But Dr. Bielicki was quick to point out that it was difficult to disentangle those factors that can easily be changed. “Some can be changed in theory, but in practice it is actually difficult to change them. One modifiable risk factor that can be changed is probably infection control, so when resistant bacteria appear in a unit, we need to ensure that there is no or minimal transmission between babies.”

Luregn Schlapbach, MD, PhD, Head, department of intensive care and neonatology, University Children’s Hospital Zurich, Switzerland, welcomed the study, saying recent recognition of pediatric and neonatal sepsis was an urgent problem worldwide.

She referred to the 2017 WHO resolution recognizing that sepsis represents a leading cause of mortality and morbidity worldwide, affecting patients of all ages, across all continents and health care systems but that many were pediatric. “At that time, our understanding of the true burden of sepsis was limited, as was our knowledge of current epidemiology,” she said in an email interview. “The Global Burden of Disease study in 2020 revealed that about half of the approximatively 50 million global sepsis cases affect pediatric age groups, many of those during neonatal age.”

The formal acknowledgment of this extensive need emphasizes the “urgency to design preventive and therapeutic interventions to reduce this devastating burden,” Dr. Schlapbach said. “In this context, the work led by GARDP is of great importance – it is designed to improve our understanding of current practice, risk factors, and burden of neonatal sepsis across low- to middle-income settings and is essential to design adequately powered trials testing interventions such as antimicrobials to improve patient outcomes and reduce the further emergence of antimicrobial resistance.”

Dr. Bielicki and Dr. Schlapbach have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – A shift toward broader-spectrum antibiotics and increasing antibiotic resistance has led to high levels of mortality and neurodevelopmental impacts in surviving babies, according to a large international study conducted on four continents.

Results of the 3-year study were presented at this week’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

The observational study, NeoOBS, conducted by the Global Antibiotic Research and Development Partnership (GARDP) and key partners from 2018 to 2020, explored the outcomes of more than 3,200 newborns, finding an overall mortality of 11% in those with suspected neonatal sepsis. The mortality rate increased to 18% in newborns in whom a pathogen was detected in blood culture.

More than half of infection-related deaths (59%) were due to hospital-acquired infections. Klebsiella pneumoniae was the most common pathogen isolated and is usually associated with hospital-acquired infections, which are increasingly resistant to existing antibiotic treatments, said a report produced by GARDP to accompany the results.

The study also identified a worrying trend: Hospitals are frequently using last-line agents such as carbapenems because of the high degree of antibiotic resistance in their facilities. Of note, 15% of babies with neonatal sepsis were given last-line antibiotics.

Pediatrician Julia Bielicki, MD, PhD, senior lecturer, Paediatric Infectious Diseases Research Group, St. George’s University of London, and clinician at the University of Basel Children’s Hospital, Switzerland, was a coinvestigator on the NeoOBS study.

In an interview, she explained that, as well as reducing mortality, the research is about managing infections better to prevent long-term events and improve the quality of life for survivors of neonatal sepsis. “It can have life-changing impacts for so many babies,” Dr. Bielicki said. “Improving care is much more than just making sure the baby survives the episode of sepsis – it’s about ensuring these babies can become children and adults and go on to lead productive lives.”

Also, only a minority of patients (13%) received the World Health Organization guidelines for standard of care use of ampicillin and gentamicin, and there was increasing use of last-line agents such as carbapenems and even polymyxins in some settings in low- and middle-income countries. “This is alarming and foretells the impending crisis of a lack of antibiotics to treat sepsis caused by multidrug-resistant organisms,” according to the GARDP report.

There was wide variability in antibiotic combinations used across sites in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Uganda, and Vietnam, and often such use was not supported by underlying data.

Dr. Bielicki remarked that there was a shift toward broad-spectrum antibiotic use. “In a high-income country, you have more restrictive patterns of antibiotic use, but it isn’t necessarily less antibiotic exposure of neonates to antibiotics, but on the whole, usually narrow-spectrum agents are used.”

In Africa and Asia, on the other hand, clinicians often have to use a broader-spectrum antibiotic empirically and may need to switch to another antibiotic very quickly. “Sometimes alternatives are not available,” she pointed out.

“Local physicians are very perceptive of this problem of antibiotic resistance in their daily practice, especially in centers with high mortality,” said Dr. Bielicki, emphasizing that it is not their fault, but is “due to the limitations in terms of the weapons available to treat these babies, which strongly demonstrates the growing problem of antimicrobial resistance affecting these babies on a global scale.”

Tim Jinks, PhD, Head of Drug Resistant Infections Priority Program at Wellcome Trust, commented on the study in a series of text messages to this news organization. “This research provides further demonstration of the urgent need for improved treatment of newborns suffering with sepsis and particularly the requirement for new antibiotics that overcome the burden of drug-resistant infections caused by [antimicrobial resistance].”

“The study is a hugely important contribution to our understanding of the burden of neonatal sepsis in low- and middle- income countries,” he added, “and points toward ways that patient treatment can be improved to save more lives.”
 

 

 

High-, middle-, and low-income countries

The NeoOBS study gathered data from 19 hospitals in 11 high-, middle-, and low-income countries and assessed which antibiotics are currently being used to treat neonatal sepsis, as well as the degree of drug resistance associated with them. Sites included some in Italy and Greece, where most of the neonatal sepsis data currently originate, and this helped to anchor the data, Dr. Bielicki said.

The study identified babies with clinical sepsis over a 4-week period and observed how these patients were managed, particularly with respect to antibiotics, as well as outcomes including whether they recovered, remained in hospital, or died. Investigators obtained bacterial cultures from the patients and grew them to identify which organisms were causing the sepsis.

Of note, mortality varied widely between hospitals, ranging from 1% to 27%. Dr. Bielicki explained that the investigators were currently exploring the reasons behind this wide range of mortality. “There are lots of possible reasons for this, including structural factors such as how care is delivered, which is complex to measure,” she said. “It isn’t trivial to measure why, in a certain setting, mortality is low and why in another setting of comparable income range, mortality is much higher.”

Aside from the mortality results, Dr. Bielicki also emphasized that the survivors of neonatal sepsis frequently experience neurodevelopmental impacts. “A hospital may have low mortality, but many of these babies may have neurodevelopment problems, and this has a long-term impact.”

“Even though mortality might be low in a certain hospital, it might not be low in terms of morbidity,” she added.

The researchers also collected isolates from the cohort of neonates to determine which antibiotic combinations work against the pathogens. “This will help us define what sort of antibiotic regimen warrants further investigation,” Dr. Bielicki said.

Principal Investigator, Mike Sharland, MD, also from St. George’s, University of London, who is also the Antimicrobial Resistance Program Lead at Penta Child Health Research, said, in a press release, that the study had shown that antibiotic resistance is now one of the major threats to neonatal health globally. “There are virtually no studies underway on developing novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections.”

“This is a major problem for babies in all countries, both rich and poor,” he stressed.
 

NeoSep-1 trial to compare multiple different treatments

The results have paved the way for a major new global trial of multiple established and new antibiotics with the goal of reducing mortality from neonatal sepsis – the NeoSep1 trial.

“This is a randomized trial with a specific design that allows us to rank different treatments against each other in terms of effectiveness, safety, and costs,” Dr. Bielicki explained.

Among the antibiotics in the study are amikacin, flomoxef and amikacin, or fosfomycin and flomoxef in babies with sepsis 28 days old or younger. Similar to the NeoOBS study, patients will be recruited from all over the world, and in particular from low- and middle-income countries such as Kenya, South Africa, and other countries in Africa and Southeast Asia.

Ultimately, the researchers want to identify modifiable risk factors and enact change in practice. But Dr. Bielicki was quick to point out that it was difficult to disentangle those factors that can easily be changed. “Some can be changed in theory, but in practice it is actually difficult to change them. One modifiable risk factor that can be changed is probably infection control, so when resistant bacteria appear in a unit, we need to ensure that there is no or minimal transmission between babies.”

Luregn Schlapbach, MD, PhD, Head, department of intensive care and neonatology, University Children’s Hospital Zurich, Switzerland, welcomed the study, saying recent recognition of pediatric and neonatal sepsis was an urgent problem worldwide.

She referred to the 2017 WHO resolution recognizing that sepsis represents a leading cause of mortality and morbidity worldwide, affecting patients of all ages, across all continents and health care systems but that many were pediatric. “At that time, our understanding of the true burden of sepsis was limited, as was our knowledge of current epidemiology,” she said in an email interview. “The Global Burden of Disease study in 2020 revealed that about half of the approximatively 50 million global sepsis cases affect pediatric age groups, many of those during neonatal age.”

The formal acknowledgment of this extensive need emphasizes the “urgency to design preventive and therapeutic interventions to reduce this devastating burden,” Dr. Schlapbach said. “In this context, the work led by GARDP is of great importance – it is designed to improve our understanding of current practice, risk factors, and burden of neonatal sepsis across low- to middle-income settings and is essential to design adequately powered trials testing interventions such as antimicrobials to improve patient outcomes and reduce the further emergence of antimicrobial resistance.”

Dr. Bielicki and Dr. Schlapbach have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Furosemide seen as safe for preventing newborn lung disease

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Tue, 04/26/2022 - 11:31

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Fetuses suffer the effects of poverty in the womb

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Thu, 04/21/2022 - 08:29

Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.

“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.

Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”

For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.

They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
 

Household income closely related to birth size

The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”

The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.

“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”

Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”

He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
 

Increase engagement with pregnant mothers living in poverty

He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”

The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.

They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”

Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care. 

“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”

A version of this article first appeared on Medscape UK.

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Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.

“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.

Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”

For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.

They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
 

Household income closely related to birth size

The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”

The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.

“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”

Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”

He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
 

Increase engagement with pregnant mothers living in poverty

He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”

The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.

They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”

Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care. 

“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”

A version of this article first appeared on Medscape UK.

Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.

“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.

Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”

For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.

They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
 

Household income closely related to birth size

The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”

The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.

“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”

Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”

He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
 

Increase engagement with pregnant mothers living in poverty

He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”

The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.

They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”

Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care. 

“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”

A version of this article first appeared on Medscape UK.

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Babies die as congenital syphilis continues a decade-long surge across the U.S.

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Changed
Sun, 09/11/2022 - 16:16

For a decade, the number of babies born with syphilis in the United States has surged, undeterred. Data released Apr. 12 by the Centers for Disease Control and Prevention shows just how dire the outbreak has become.

In 2012, 332 babies were born infected with the disease. In 2021, that number had climbed nearly sevenfold, to at least 2,268, according to preliminary estimates. And 166 of those babies died.

About 7% of babies diagnosed with syphilis in recent years have died; thousands of others born with the disease have faced problems that include brain and bone malformations, blindness, and organ damage.

For public health officials, the situation is all the more heartbreaking, considering that congenital syphilis rates reached near-historic modern lows from 2000 to 2012 amid ambitious prevention and education efforts. By 2020, following a sharp erosion in funding and attention, the nationwide case rate was more than seven times that of 2012.

“The really depressing thing about it is we had this thing virtually eradicated back in the year 2000,” said William Andrews, a public information officer for Oklahoma’s sexual health and harm reduction service. “Now it’s back with a vengeance. We are really trying to get the message out that sexual health is health. It’s nothing to be ashamed of.”

Even as caseloads soar, the CDC budget for STD prevention – the primary funding source for most public health departments – has been largely stagnant for two decades, its purchasing power dragged even lower by inflation.

The CDC report on STD trends provides official data on congenital syphilis cases for 2020, as well as preliminary case counts for 2021 that are expected to increase. CDC data shows that congenital syphilis rates in 2020 continued to climb in already overwhelmed states like Texas, California, and Nevada and that the disease is now present in almost every state in the nation. All but three states – Maine, New Hampshire, and Vermont – reported congenital syphilis cases in 2020.

From 2011 to 2020, congenital syphilis resulted in 633 documented stillbirths and infant deaths, according to the new CDC data.

Preventing congenital syphilis – the term used when syphilis is transferred to a fetus in utero – is from a medical standpoint exceedingly simple: If a pregnant woman is diagnosed at least a month before giving birth, just a few shots of penicillin have a near-perfect cure rate for mother and baby. But funding cuts and competing priorities in the nation’s fragmented public health care system have vastly narrowed access to such services.

The reasons pregnant people with syphilis go undiagnosed or untreated vary geographically, according to data collected by states and analyzed by the CDC.

In Western states, the largest share of cases involve women who have received little to no prenatal care and aren’t tested for syphilis until they give birth. Many have substance use disorders, primarily related to methamphetamines. “They’ve felt a lot of judgment and stigma by the medical community,” said Stephanie Pierce, MD, a maternal fetal medicine specialist at the University of Oklahoma, Oklahoma City, who runs a clinic for women with high-risk pregnancies.

In Southern states, a CDC study of 2018 data found that the largest share of congenital syphilis cases were among women who had been tested and diagnosed but hadn’t received treatment. That year, among Black moms who gave birth to a baby with syphilis, 37% had not been treated adequately even though they’d received a timely diagnosis. Among white moms, that number was 24%. Longstanding racism in medical care, poverty, transportation issues, poorly funded public health departments, and crowded clinics whose employees are too overworked to follow up with patients all contribute to the problem, according to infectious disease experts.

Doctors are also noticing a growing number of women who are treated for syphilis but reinfected during pregnancy. Amid rising cases and stagnant resources, some states have focused disease investigations on pregnant women of childbearing age; they can no longer prioritize treating sexual partners who are also infected.

Eric McGrath, MD, a pediatric infectious disease specialist at Wayne State University, Detroit, said that he’d seen several newborns in recent years whose mothers had been treated for syphilis but then were re-exposed during pregnancy by partners who hadn’t been treated.

Treating a newborn baby for syphilis isn’t trivial. Penicillin carries little risk, but delivering it to a baby often involves a lumbar puncture and other painful procedures. And treatment typically means keeping the baby in the hospital for 10 days, interrupting an important time for family bonding.

Dr. McGrath has seen a couple of babies in his career who weren’t diagnosed or treated at birth and later came to him with full-blown syphilis complications, including full-body rashes and inflamed livers. It was an awful experience he doesn’t want to repeat. The preferred course, he said, is to spare the baby the ordeal and treat parents early in the pregnancy.

But in some places, providers aren’t routinely testing for syphilis. Although most states mandate testing at some point during pregnancy, as of last year just 14 required it for everyone in the third trimester. The CDC recommends third-trimester testing in areas with high rates of syphilis, a growing share of the United States.

After Arizona declared a statewide outbreak in 2018, state health officials wanted to know whether widespread testing in the third trimester could have prevented infections. Looking at 18 months of data, analysts found that nearly three-quarters of the more than 200 pregnant women diagnosed with syphilis in 2017 and the first half of 2018 got treatment. That left 57 babies born with syphilis, nine of whom died. The analysts estimated that a third of the infections could have been prevented with testing in the third trimester.

Based on the numbers they saw in those 18 months, officials estimated that screening all women on Medicaid in the third trimester would cost the state $113,300 annually, and that treating all cases of syphilis that screening would catch could be done for just $113. Factoring in the hospitalization costs for infected infants, the officials concluded the additional testing would save the state money.

And yet prevention money has been hard to come by. Taking inflation into account, CDC prevention funding for STDs has fallen 41% since 2003, according to an analysis by the National Coalition of STD Directors. That’s even as cases have risen, leaving public health departments saddled with more work and far less money.

Janine Waters, STD program manager for the state of New Mexico, has watched the unraveling. When Ms. Waters started her career more than 20 years ago, she and her colleagues followed up on every case of chlamydia, gonorrhea, and syphilis reported, not only making sure that people got treatment but also getting in touch with their sexual partners, with the aim of stopping the spread of infection. In a 2019 interview with Kaiser Health News, she said her team was struggling to keep up with syphilis alone, even as they registered with dread congenital syphilis cases surging in neighboring Texas and Arizona.

By 2020, New Mexico had the highest rate of congenital syphilis in the country.

The COVID-19 pandemic drained the remaining resources. Half of health departments across the country discontinued STD fieldwork altogether, diverting their resources to COVID. In California, which for years has struggled with high rates of congenital syphilis, three-quarters of local health departments dispatched more than half of their STD staffers to work on COVID.

As the pandemic ebbs – at least in the short term – many public health departments are turning their attention back to syphilis and other diseases. And they are doing it with reinforcements. Although the Biden administration’s proposed STD prevention budget for 2023 remains flat, the American Rescue Plan Act included $200 million to help health departments boost contact tracing and surveillance for covid and other infectious diseases. Many departments are funneling that money toward STDs.

The money is an infusion that state health officials say will make a difference. But when taking inflation into account, it essentially brings STD prevention funding back to what it was in 2003, said Stephanie Arnold Pang of the National Coalition of STD Directors. And the American Rescue Plan money doesn’t cover some aspects of STD prevention, including clinical services.

The coalition wants to revive dedicated STD clinics, where people can drop in for testing and treatment at little to no cost. Advocates say that would fill a void that has plagued treatment efforts since public clinics closed en masse in the wake of the 2008 recession.

Texas, battling its own pervasive outbreak, will use its share of American Rescue Plan money to fill 94 new positions focused on various aspects of STD prevention. Those hires will bolster a range of measures the state put in place before the pandemic, including an updated data system to track infections, review boards in major cities that examine what went wrong for every case of congenital syphilis, and a requirement that providers test for syphilis during the third trimester of pregnancy. The suite of interventions seems to be working, but it could be a while before cases go down, said Amy Carter, the state’s congenital syphilis coordinator.

“The growth didn’t happen overnight,” Ms. Carter said. “So our prevention efforts aren’t going to have a direct impact overnight either.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation

 

 

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For a decade, the number of babies born with syphilis in the United States has surged, undeterred. Data released Apr. 12 by the Centers for Disease Control and Prevention shows just how dire the outbreak has become.

In 2012, 332 babies were born infected with the disease. In 2021, that number had climbed nearly sevenfold, to at least 2,268, according to preliminary estimates. And 166 of those babies died.

About 7% of babies diagnosed with syphilis in recent years have died; thousands of others born with the disease have faced problems that include brain and bone malformations, blindness, and organ damage.

For public health officials, the situation is all the more heartbreaking, considering that congenital syphilis rates reached near-historic modern lows from 2000 to 2012 amid ambitious prevention and education efforts. By 2020, following a sharp erosion in funding and attention, the nationwide case rate was more than seven times that of 2012.

“The really depressing thing about it is we had this thing virtually eradicated back in the year 2000,” said William Andrews, a public information officer for Oklahoma’s sexual health and harm reduction service. “Now it’s back with a vengeance. We are really trying to get the message out that sexual health is health. It’s nothing to be ashamed of.”

Even as caseloads soar, the CDC budget for STD prevention – the primary funding source for most public health departments – has been largely stagnant for two decades, its purchasing power dragged even lower by inflation.

The CDC report on STD trends provides official data on congenital syphilis cases for 2020, as well as preliminary case counts for 2021 that are expected to increase. CDC data shows that congenital syphilis rates in 2020 continued to climb in already overwhelmed states like Texas, California, and Nevada and that the disease is now present in almost every state in the nation. All but three states – Maine, New Hampshire, and Vermont – reported congenital syphilis cases in 2020.

From 2011 to 2020, congenital syphilis resulted in 633 documented stillbirths and infant deaths, according to the new CDC data.

Preventing congenital syphilis – the term used when syphilis is transferred to a fetus in utero – is from a medical standpoint exceedingly simple: If a pregnant woman is diagnosed at least a month before giving birth, just a few shots of penicillin have a near-perfect cure rate for mother and baby. But funding cuts and competing priorities in the nation’s fragmented public health care system have vastly narrowed access to such services.

The reasons pregnant people with syphilis go undiagnosed or untreated vary geographically, according to data collected by states and analyzed by the CDC.

In Western states, the largest share of cases involve women who have received little to no prenatal care and aren’t tested for syphilis until they give birth. Many have substance use disorders, primarily related to methamphetamines. “They’ve felt a lot of judgment and stigma by the medical community,” said Stephanie Pierce, MD, a maternal fetal medicine specialist at the University of Oklahoma, Oklahoma City, who runs a clinic for women with high-risk pregnancies.

In Southern states, a CDC study of 2018 data found that the largest share of congenital syphilis cases were among women who had been tested and diagnosed but hadn’t received treatment. That year, among Black moms who gave birth to a baby with syphilis, 37% had not been treated adequately even though they’d received a timely diagnosis. Among white moms, that number was 24%. Longstanding racism in medical care, poverty, transportation issues, poorly funded public health departments, and crowded clinics whose employees are too overworked to follow up with patients all contribute to the problem, according to infectious disease experts.

Doctors are also noticing a growing number of women who are treated for syphilis but reinfected during pregnancy. Amid rising cases and stagnant resources, some states have focused disease investigations on pregnant women of childbearing age; they can no longer prioritize treating sexual partners who are also infected.

Eric McGrath, MD, a pediatric infectious disease specialist at Wayne State University, Detroit, said that he’d seen several newborns in recent years whose mothers had been treated for syphilis but then were re-exposed during pregnancy by partners who hadn’t been treated.

Treating a newborn baby for syphilis isn’t trivial. Penicillin carries little risk, but delivering it to a baby often involves a lumbar puncture and other painful procedures. And treatment typically means keeping the baby in the hospital for 10 days, interrupting an important time for family bonding.

Dr. McGrath has seen a couple of babies in his career who weren’t diagnosed or treated at birth and later came to him with full-blown syphilis complications, including full-body rashes and inflamed livers. It was an awful experience he doesn’t want to repeat. The preferred course, he said, is to spare the baby the ordeal and treat parents early in the pregnancy.

But in some places, providers aren’t routinely testing for syphilis. Although most states mandate testing at some point during pregnancy, as of last year just 14 required it for everyone in the third trimester. The CDC recommends third-trimester testing in areas with high rates of syphilis, a growing share of the United States.

After Arizona declared a statewide outbreak in 2018, state health officials wanted to know whether widespread testing in the third trimester could have prevented infections. Looking at 18 months of data, analysts found that nearly three-quarters of the more than 200 pregnant women diagnosed with syphilis in 2017 and the first half of 2018 got treatment. That left 57 babies born with syphilis, nine of whom died. The analysts estimated that a third of the infections could have been prevented with testing in the third trimester.

Based on the numbers they saw in those 18 months, officials estimated that screening all women on Medicaid in the third trimester would cost the state $113,300 annually, and that treating all cases of syphilis that screening would catch could be done for just $113. Factoring in the hospitalization costs for infected infants, the officials concluded the additional testing would save the state money.

And yet prevention money has been hard to come by. Taking inflation into account, CDC prevention funding for STDs has fallen 41% since 2003, according to an analysis by the National Coalition of STD Directors. That’s even as cases have risen, leaving public health departments saddled with more work and far less money.

Janine Waters, STD program manager for the state of New Mexico, has watched the unraveling. When Ms. Waters started her career more than 20 years ago, she and her colleagues followed up on every case of chlamydia, gonorrhea, and syphilis reported, not only making sure that people got treatment but also getting in touch with their sexual partners, with the aim of stopping the spread of infection. In a 2019 interview with Kaiser Health News, she said her team was struggling to keep up with syphilis alone, even as they registered with dread congenital syphilis cases surging in neighboring Texas and Arizona.

By 2020, New Mexico had the highest rate of congenital syphilis in the country.

The COVID-19 pandemic drained the remaining resources. Half of health departments across the country discontinued STD fieldwork altogether, diverting their resources to COVID. In California, which for years has struggled with high rates of congenital syphilis, three-quarters of local health departments dispatched more than half of their STD staffers to work on COVID.

As the pandemic ebbs – at least in the short term – many public health departments are turning their attention back to syphilis and other diseases. And they are doing it with reinforcements. Although the Biden administration’s proposed STD prevention budget for 2023 remains flat, the American Rescue Plan Act included $200 million to help health departments boost contact tracing and surveillance for covid and other infectious diseases. Many departments are funneling that money toward STDs.

The money is an infusion that state health officials say will make a difference. But when taking inflation into account, it essentially brings STD prevention funding back to what it was in 2003, said Stephanie Arnold Pang of the National Coalition of STD Directors. And the American Rescue Plan money doesn’t cover some aspects of STD prevention, including clinical services.

The coalition wants to revive dedicated STD clinics, where people can drop in for testing and treatment at little to no cost. Advocates say that would fill a void that has plagued treatment efforts since public clinics closed en masse in the wake of the 2008 recession.

Texas, battling its own pervasive outbreak, will use its share of American Rescue Plan money to fill 94 new positions focused on various aspects of STD prevention. Those hires will bolster a range of measures the state put in place before the pandemic, including an updated data system to track infections, review boards in major cities that examine what went wrong for every case of congenital syphilis, and a requirement that providers test for syphilis during the third trimester of pregnancy. The suite of interventions seems to be working, but it could be a while before cases go down, said Amy Carter, the state’s congenital syphilis coordinator.

“The growth didn’t happen overnight,” Ms. Carter said. “So our prevention efforts aren’t going to have a direct impact overnight either.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation

 

 

For a decade, the number of babies born with syphilis in the United States has surged, undeterred. Data released Apr. 12 by the Centers for Disease Control and Prevention shows just how dire the outbreak has become.

In 2012, 332 babies were born infected with the disease. In 2021, that number had climbed nearly sevenfold, to at least 2,268, according to preliminary estimates. And 166 of those babies died.

About 7% of babies diagnosed with syphilis in recent years have died; thousands of others born with the disease have faced problems that include brain and bone malformations, blindness, and organ damage.

For public health officials, the situation is all the more heartbreaking, considering that congenital syphilis rates reached near-historic modern lows from 2000 to 2012 amid ambitious prevention and education efforts. By 2020, following a sharp erosion in funding and attention, the nationwide case rate was more than seven times that of 2012.

“The really depressing thing about it is we had this thing virtually eradicated back in the year 2000,” said William Andrews, a public information officer for Oklahoma’s sexual health and harm reduction service. “Now it’s back with a vengeance. We are really trying to get the message out that sexual health is health. It’s nothing to be ashamed of.”

Even as caseloads soar, the CDC budget for STD prevention – the primary funding source for most public health departments – has been largely stagnant for two decades, its purchasing power dragged even lower by inflation.

The CDC report on STD trends provides official data on congenital syphilis cases for 2020, as well as preliminary case counts for 2021 that are expected to increase. CDC data shows that congenital syphilis rates in 2020 continued to climb in already overwhelmed states like Texas, California, and Nevada and that the disease is now present in almost every state in the nation. All but three states – Maine, New Hampshire, and Vermont – reported congenital syphilis cases in 2020.

From 2011 to 2020, congenital syphilis resulted in 633 documented stillbirths and infant deaths, according to the new CDC data.

Preventing congenital syphilis – the term used when syphilis is transferred to a fetus in utero – is from a medical standpoint exceedingly simple: If a pregnant woman is diagnosed at least a month before giving birth, just a few shots of penicillin have a near-perfect cure rate for mother and baby. But funding cuts and competing priorities in the nation’s fragmented public health care system have vastly narrowed access to such services.

The reasons pregnant people with syphilis go undiagnosed or untreated vary geographically, according to data collected by states and analyzed by the CDC.

In Western states, the largest share of cases involve women who have received little to no prenatal care and aren’t tested for syphilis until they give birth. Many have substance use disorders, primarily related to methamphetamines. “They’ve felt a lot of judgment and stigma by the medical community,” said Stephanie Pierce, MD, a maternal fetal medicine specialist at the University of Oklahoma, Oklahoma City, who runs a clinic for women with high-risk pregnancies.

In Southern states, a CDC study of 2018 data found that the largest share of congenital syphilis cases were among women who had been tested and diagnosed but hadn’t received treatment. That year, among Black moms who gave birth to a baby with syphilis, 37% had not been treated adequately even though they’d received a timely diagnosis. Among white moms, that number was 24%. Longstanding racism in medical care, poverty, transportation issues, poorly funded public health departments, and crowded clinics whose employees are too overworked to follow up with patients all contribute to the problem, according to infectious disease experts.

Doctors are also noticing a growing number of women who are treated for syphilis but reinfected during pregnancy. Amid rising cases and stagnant resources, some states have focused disease investigations on pregnant women of childbearing age; they can no longer prioritize treating sexual partners who are also infected.

Eric McGrath, MD, a pediatric infectious disease specialist at Wayne State University, Detroit, said that he’d seen several newborns in recent years whose mothers had been treated for syphilis but then were re-exposed during pregnancy by partners who hadn’t been treated.

Treating a newborn baby for syphilis isn’t trivial. Penicillin carries little risk, but delivering it to a baby often involves a lumbar puncture and other painful procedures. And treatment typically means keeping the baby in the hospital for 10 days, interrupting an important time for family bonding.

Dr. McGrath has seen a couple of babies in his career who weren’t diagnosed or treated at birth and later came to him with full-blown syphilis complications, including full-body rashes and inflamed livers. It was an awful experience he doesn’t want to repeat. The preferred course, he said, is to spare the baby the ordeal and treat parents early in the pregnancy.

But in some places, providers aren’t routinely testing for syphilis. Although most states mandate testing at some point during pregnancy, as of last year just 14 required it for everyone in the third trimester. The CDC recommends third-trimester testing in areas with high rates of syphilis, a growing share of the United States.

After Arizona declared a statewide outbreak in 2018, state health officials wanted to know whether widespread testing in the third trimester could have prevented infections. Looking at 18 months of data, analysts found that nearly three-quarters of the more than 200 pregnant women diagnosed with syphilis in 2017 and the first half of 2018 got treatment. That left 57 babies born with syphilis, nine of whom died. The analysts estimated that a third of the infections could have been prevented with testing in the third trimester.

Based on the numbers they saw in those 18 months, officials estimated that screening all women on Medicaid in the third trimester would cost the state $113,300 annually, and that treating all cases of syphilis that screening would catch could be done for just $113. Factoring in the hospitalization costs for infected infants, the officials concluded the additional testing would save the state money.

And yet prevention money has been hard to come by. Taking inflation into account, CDC prevention funding for STDs has fallen 41% since 2003, according to an analysis by the National Coalition of STD Directors. That’s even as cases have risen, leaving public health departments saddled with more work and far less money.

Janine Waters, STD program manager for the state of New Mexico, has watched the unraveling. When Ms. Waters started her career more than 20 years ago, she and her colleagues followed up on every case of chlamydia, gonorrhea, and syphilis reported, not only making sure that people got treatment but also getting in touch with their sexual partners, with the aim of stopping the spread of infection. In a 2019 interview with Kaiser Health News, she said her team was struggling to keep up with syphilis alone, even as they registered with dread congenital syphilis cases surging in neighboring Texas and Arizona.

By 2020, New Mexico had the highest rate of congenital syphilis in the country.

The COVID-19 pandemic drained the remaining resources. Half of health departments across the country discontinued STD fieldwork altogether, diverting their resources to COVID. In California, which for years has struggled with high rates of congenital syphilis, three-quarters of local health departments dispatched more than half of their STD staffers to work on COVID.

As the pandemic ebbs – at least in the short term – many public health departments are turning their attention back to syphilis and other diseases. And they are doing it with reinforcements. Although the Biden administration’s proposed STD prevention budget for 2023 remains flat, the American Rescue Plan Act included $200 million to help health departments boost contact tracing and surveillance for covid and other infectious diseases. Many departments are funneling that money toward STDs.

The money is an infusion that state health officials say will make a difference. But when taking inflation into account, it essentially brings STD prevention funding back to what it was in 2003, said Stephanie Arnold Pang of the National Coalition of STD Directors. And the American Rescue Plan money doesn’t cover some aspects of STD prevention, including clinical services.

The coalition wants to revive dedicated STD clinics, where people can drop in for testing and treatment at little to no cost. Advocates say that would fill a void that has plagued treatment efforts since public clinics closed en masse in the wake of the 2008 recession.

Texas, battling its own pervasive outbreak, will use its share of American Rescue Plan money to fill 94 new positions focused on various aspects of STD prevention. Those hires will bolster a range of measures the state put in place before the pandemic, including an updated data system to track infections, review boards in major cities that examine what went wrong for every case of congenital syphilis, and a requirement that providers test for syphilis during the third trimester of pregnancy. The suite of interventions seems to be working, but it could be a while before cases go down, said Amy Carter, the state’s congenital syphilis coordinator.

“The growth didn’t happen overnight,” Ms. Carter said. “So our prevention efforts aren’t going to have a direct impact overnight either.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation

 

 

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Monitor children’s thyroids after iodine exposure for imaging, FDA says

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Wed, 03/30/2022 - 17:37

The Food and Drug Administration has recommended thyroid monitoring for newborns and children through 3 years of age within 3 weeks of receiving injections of iodine-containing contrast media as part of imaging procedures.

A recent FDA review showed that “underactive thyroid or a temporary decrease in thyroid hormone levels were uncommon,” according to an updated Drug Safety Communication issued on March 30, 2022.

However, early monitoring will help identify and treat any thyroid abnormalities as a result of the injections to help prevent potential complications in the future, according to the FDA, as babies and children do not generally show visible signs of thyroid problems and may not do so after an iodinated contrast media (ICM) injection.

ICM have been approved and used for decades to enhance images on x-rays or computed tomography (CT) scans, according to the communication.

The new FDA warning and recommendation for monitoring applies to the prescribing information for the entire class of ICM products. The new communication is an update to the 2015 Drug Safety Communication that advised medical professionals of the potential for underactive thyroid in response to ICM injections in newborns and young children. The update reflects new studies since that time.

The recent research showed that most reported cases of adverse effects were transient subclinical hypothyroidism and did not require treatment, according to the FDA. “The reported rate ranged from 1 percent to 15 percent and tended to be higher in neonates, particularly preterm neonates,” they said. Others at increased risk are those with underlying medical conditions, especially those with cardiac conditions who often require higher doses of contrast during invasive procedures.

In the recent studies, the time from ICM exposure to a diagnosis of thyroid dysfunction ranged from 8.5 to 138 days, but most occurred within 3 weeks, according to the update.

Patients and clinicians can report any adverse events from ICM or other medications to the FDA via FDA MedWatch program.

For more information, read the complete Drug Safety Communication.

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The Food and Drug Administration has recommended thyroid monitoring for newborns and children through 3 years of age within 3 weeks of receiving injections of iodine-containing contrast media as part of imaging procedures.

A recent FDA review showed that “underactive thyroid or a temporary decrease in thyroid hormone levels were uncommon,” according to an updated Drug Safety Communication issued on March 30, 2022.

However, early monitoring will help identify and treat any thyroid abnormalities as a result of the injections to help prevent potential complications in the future, according to the FDA, as babies and children do not generally show visible signs of thyroid problems and may not do so after an iodinated contrast media (ICM) injection.

ICM have been approved and used for decades to enhance images on x-rays or computed tomography (CT) scans, according to the communication.

The new FDA warning and recommendation for monitoring applies to the prescribing information for the entire class of ICM products. The new communication is an update to the 2015 Drug Safety Communication that advised medical professionals of the potential for underactive thyroid in response to ICM injections in newborns and young children. The update reflects new studies since that time.

The recent research showed that most reported cases of adverse effects were transient subclinical hypothyroidism and did not require treatment, according to the FDA. “The reported rate ranged from 1 percent to 15 percent and tended to be higher in neonates, particularly preterm neonates,” they said. Others at increased risk are those with underlying medical conditions, especially those with cardiac conditions who often require higher doses of contrast during invasive procedures.

In the recent studies, the time from ICM exposure to a diagnosis of thyroid dysfunction ranged from 8.5 to 138 days, but most occurred within 3 weeks, according to the update.

Patients and clinicians can report any adverse events from ICM or other medications to the FDA via FDA MedWatch program.

For more information, read the complete Drug Safety Communication.

The Food and Drug Administration has recommended thyroid monitoring for newborns and children through 3 years of age within 3 weeks of receiving injections of iodine-containing contrast media as part of imaging procedures.

A recent FDA review showed that “underactive thyroid or a temporary decrease in thyroid hormone levels were uncommon,” according to an updated Drug Safety Communication issued on March 30, 2022.

However, early monitoring will help identify and treat any thyroid abnormalities as a result of the injections to help prevent potential complications in the future, according to the FDA, as babies and children do not generally show visible signs of thyroid problems and may not do so after an iodinated contrast media (ICM) injection.

ICM have been approved and used for decades to enhance images on x-rays or computed tomography (CT) scans, according to the communication.

The new FDA warning and recommendation for monitoring applies to the prescribing information for the entire class of ICM products. The new communication is an update to the 2015 Drug Safety Communication that advised medical professionals of the potential for underactive thyroid in response to ICM injections in newborns and young children. The update reflects new studies since that time.

The recent research showed that most reported cases of adverse effects were transient subclinical hypothyroidism and did not require treatment, according to the FDA. “The reported rate ranged from 1 percent to 15 percent and tended to be higher in neonates, particularly preterm neonates,” they said. Others at increased risk are those with underlying medical conditions, especially those with cardiac conditions who often require higher doses of contrast during invasive procedures.

In the recent studies, the time from ICM exposure to a diagnosis of thyroid dysfunction ranged from 8.5 to 138 days, but most occurred within 3 weeks, according to the update.

Patients and clinicians can report any adverse events from ICM or other medications to the FDA via FDA MedWatch program.

For more information, read the complete Drug Safety Communication.

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Senate approves bill to ban crib bumpers

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Tue, 03/29/2022 - 16:30

The Senate on Mar. 23 approved a bill to ban the sale of padded crib bumpers, which have been deemed risky by public health experts.

The Safe Cribs Act, introduced by Sen. Rob Portman (R-Ohio) and Sen. Tammy Duckworth (D-Ill.), would prohibit making and distributing bumpers – soft pads made to protect babies from hard sides of cribs – which have been found to increase suffocation risk.

Ivan Strba/iStockphoto.com

The bill will now head to the House of Representatives.

According to data from the Consumer Product Safety Commission, 107 babies died in cribs with bumpers between 1990 and 2016, and 282 nonfatal incidents with bumpers were reported, including near-misses for strangulation and suffocation.

The American Academy of Pediatrics recommends keeping babies’ cribs free of any objects, including bumpers.

Despite this, bumpers are still widely sold by retailers.

“The fact that these deadly products can still be found on shelves across the country is extremely confusing to new parents who don’t believe stores would be selling them if they were truly dangerous to babies,” Sen. Duckworth said in a statement.

A 2020 survey released by Johns Hopkins University found that many parents were unaware of the dangers posed by crib bumpers and assumed they would be removed from stores if found unsafe.

Maryland banned the sale of bumpers in 2013, followed by Ohio in 2017. Chicago became the first city to ban them in 2011.

A version of this article first appeared on WebMD.com.

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The Senate on Mar. 23 approved a bill to ban the sale of padded crib bumpers, which have been deemed risky by public health experts.

The Safe Cribs Act, introduced by Sen. Rob Portman (R-Ohio) and Sen. Tammy Duckworth (D-Ill.), would prohibit making and distributing bumpers – soft pads made to protect babies from hard sides of cribs – which have been found to increase suffocation risk.

Ivan Strba/iStockphoto.com

The bill will now head to the House of Representatives.

According to data from the Consumer Product Safety Commission, 107 babies died in cribs with bumpers between 1990 and 2016, and 282 nonfatal incidents with bumpers were reported, including near-misses for strangulation and suffocation.

The American Academy of Pediatrics recommends keeping babies’ cribs free of any objects, including bumpers.

Despite this, bumpers are still widely sold by retailers.

“The fact that these deadly products can still be found on shelves across the country is extremely confusing to new parents who don’t believe stores would be selling them if they were truly dangerous to babies,” Sen. Duckworth said in a statement.

A 2020 survey released by Johns Hopkins University found that many parents were unaware of the dangers posed by crib bumpers and assumed they would be removed from stores if found unsafe.

Maryland banned the sale of bumpers in 2013, followed by Ohio in 2017. Chicago became the first city to ban them in 2011.

A version of this article first appeared on WebMD.com.

The Senate on Mar. 23 approved a bill to ban the sale of padded crib bumpers, which have been deemed risky by public health experts.

The Safe Cribs Act, introduced by Sen. Rob Portman (R-Ohio) and Sen. Tammy Duckworth (D-Ill.), would prohibit making and distributing bumpers – soft pads made to protect babies from hard sides of cribs – which have been found to increase suffocation risk.

Ivan Strba/iStockphoto.com

The bill will now head to the House of Representatives.

According to data from the Consumer Product Safety Commission, 107 babies died in cribs with bumpers between 1990 and 2016, and 282 nonfatal incidents with bumpers were reported, including near-misses for strangulation and suffocation.

The American Academy of Pediatrics recommends keeping babies’ cribs free of any objects, including bumpers.

Despite this, bumpers are still widely sold by retailers.

“The fact that these deadly products can still be found on shelves across the country is extremely confusing to new parents who don’t believe stores would be selling them if they were truly dangerous to babies,” Sen. Duckworth said in a statement.

A 2020 survey released by Johns Hopkins University found that many parents were unaware of the dangers posed by crib bumpers and assumed they would be removed from stores if found unsafe.

Maryland banned the sale of bumpers in 2013, followed by Ohio in 2017. Chicago became the first city to ban them in 2011.

A version of this article first appeared on WebMD.com.

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Neonatal hypoglycemia doesn’t affect childhood academics

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Tue, 03/29/2022 - 15:44

Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

 

 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

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Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

 

 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

 

 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

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ADHD link to prenatal opioid exposure shifts with other substances

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Tue, 03/29/2022 - 11:18

Children prenatally exposed to opioids alone have an increased risk of attention-deficit/hyperactivity disorder (ADHD), but interactions between opioids and both cannabis use and alcohol use were linked to varying levels of ADHD risk as well, according to findings published March 11 in JAMA Network Open.

While many prenatal exposure studies examine associations with one substance, the results of this case-control study “suggest that it is important to consider prenatal exposure to multiple substances and the interactions between these substances when counseling women regarding substance use during pregnancy,” wrote Henri M. Garrison-Desany of the Johns Hopkins University, Baltimore, and colleagues.

Using data from children in the prospective Boston Birth Cohort between 1998 and 2019, the researchers did a secondary analysis on the 3,138 children (50.4% of whom were male) with at least 2 years of follow-up, excluding children from multiple-gestation pregnancies, in vitro fertilization pregnancies, and deliveries involving major maternal trauma or major chromosomal anomalies. Mothers answered a questionnaire within 24-72 hours of delivery regarding their demographics, substance use, pregnancy history, and health status. Among the mothers, 58.6% were Black, 22.3% were Hispanic, 7.2% were White, 1.5% were Asian, and 10.4% were other races/ethnicities.

The children’s electronic medical records were used to identify those with ADHD diagnoses. The researchers did not assess prescription opioid exposure during pregnancy, but they based opioid exposure on mothers’ reports of recreationally using heroin or oxycodone, mothers’ reports of receiving methadone treatment, or a newborn diagnosis of neonatal abstinence syndrome or neonatal opioid withdrawal syndrome.

Just under a quarter of the women (24.2%) reported using at least one substance during pregnancy. After tobacco smoking (18.5%), the next most reported substances were alcohol (8.1%), cannabis (3.9%), and opioids (1.9%). With a median 12 years of follow-up, 15.5% of the children had been diagnosed with ADHD, most of whom (71.6%) were male.

Before considering interaction of different substances, children exposed to opioids had a little over twice the risk of ADHD (hazard ratio [HR], 2.19) compared to those with no prenatal substance exposure. Although neither cannabis nor alcohol was independently associated with ADHD, smoking had a 40% increased risk, and researchers found a 21% increase in risk of ADHD with each additional substance mothers used during pregnancy. The researchers had adjusted these findings for maternal age, race/ethnicity, marital status, educational level, annual household income, parity, number of perinatal visits, and general stress during pregnancy, based on a structured interview.

When the researchers considered all the substances together, opioid exposure increased risk of ADHD by 60% (HR, 1.6), opioids with cannabis increased risk by 42%, opioids with alcohol increased risk by 15%, and opioids with smoking increased risk by 17%.

”Our findings suggest opioids may interact with other substances (including cannabis), which may be particularly deleterious,” the researchers reported. “It is not clear whether this interaction is owing to biological or environmental factors, such as whether individuals with illicit polysubstance use are more likely to use more substances or whether they have other characteristics that may impact child development.”

The authors noted that cannabis exposure has been linked to other neurodevelopmental outcomes, including reduced executive and motor function in infants. ”Notably, although we did not find a significant independent association between cannabis exposure and ADHD, children exposed to both cannabis and opioids had a 23% greater risk than expected from either exposure individually,” they reported.

The researchers suggest that their findings provide data for considering harm reduction approaches that reduce use of any single substance during pregnancy. “Focusing on the most obviously harmful exposures may be a useful way to reduce the risk of ADHD,” they wrote. “Further work is needed to directly investigate this hypothesis and examine whether reduction in the use of any substance among those with polysubstance use could be acceptable compared with abstinence.”

In an invited commentary, Angela Lupattelli, PhD, and Nhung T. H. Trinh, PhD, both of the department of pharmacy at the University of Oslo, noted the methodological challenges of assessing exposures and associations from multiple different substances during pregnancy.

“First, how can we disentangle the consequences of individual and/or combined substance exposures during pregnancy from the underlying risks?” they asked. In addition to differences in baseline characteristic between those who use opioids or cannabis, Dr. Lupattelli and Dr. Trinh noted that other important unmeasured factors, such as genetics and family environment, may confound the effect size estimates for ADHD.

They also noted the need to consider intensity, dose, duration, and timing of substance use during pregnancy.

“Understanding the longer-term safety of substance use during pregnancy is paramount to inform prevention policy and shape counseling strategies. Observational studies, despite their limitations, are a necessary piece of the puzzle,” they wrote. “However, the study findings should be interpreted with caution, as the use of advanced analytical methods cannot overcome the unavailability of some important confounding factors and exposure information.”

The research was funded by the U.S. Department of Health and Human Services and the National Institutes of Health. The authors had no industry-related disclosures.

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Children prenatally exposed to opioids alone have an increased risk of attention-deficit/hyperactivity disorder (ADHD), but interactions between opioids and both cannabis use and alcohol use were linked to varying levels of ADHD risk as well, according to findings published March 11 in JAMA Network Open.

While many prenatal exposure studies examine associations with one substance, the results of this case-control study “suggest that it is important to consider prenatal exposure to multiple substances and the interactions between these substances when counseling women regarding substance use during pregnancy,” wrote Henri M. Garrison-Desany of the Johns Hopkins University, Baltimore, and colleagues.

Using data from children in the prospective Boston Birth Cohort between 1998 and 2019, the researchers did a secondary analysis on the 3,138 children (50.4% of whom were male) with at least 2 years of follow-up, excluding children from multiple-gestation pregnancies, in vitro fertilization pregnancies, and deliveries involving major maternal trauma or major chromosomal anomalies. Mothers answered a questionnaire within 24-72 hours of delivery regarding their demographics, substance use, pregnancy history, and health status. Among the mothers, 58.6% were Black, 22.3% were Hispanic, 7.2% were White, 1.5% were Asian, and 10.4% were other races/ethnicities.

The children’s electronic medical records were used to identify those with ADHD diagnoses. The researchers did not assess prescription opioid exposure during pregnancy, but they based opioid exposure on mothers’ reports of recreationally using heroin or oxycodone, mothers’ reports of receiving methadone treatment, or a newborn diagnosis of neonatal abstinence syndrome or neonatal opioid withdrawal syndrome.

Just under a quarter of the women (24.2%) reported using at least one substance during pregnancy. After tobacco smoking (18.5%), the next most reported substances were alcohol (8.1%), cannabis (3.9%), and opioids (1.9%). With a median 12 years of follow-up, 15.5% of the children had been diagnosed with ADHD, most of whom (71.6%) were male.

Before considering interaction of different substances, children exposed to opioids had a little over twice the risk of ADHD (hazard ratio [HR], 2.19) compared to those with no prenatal substance exposure. Although neither cannabis nor alcohol was independently associated with ADHD, smoking had a 40% increased risk, and researchers found a 21% increase in risk of ADHD with each additional substance mothers used during pregnancy. The researchers had adjusted these findings for maternal age, race/ethnicity, marital status, educational level, annual household income, parity, number of perinatal visits, and general stress during pregnancy, based on a structured interview.

When the researchers considered all the substances together, opioid exposure increased risk of ADHD by 60% (HR, 1.6), opioids with cannabis increased risk by 42%, opioids with alcohol increased risk by 15%, and opioids with smoking increased risk by 17%.

”Our findings suggest opioids may interact with other substances (including cannabis), which may be particularly deleterious,” the researchers reported. “It is not clear whether this interaction is owing to biological or environmental factors, such as whether individuals with illicit polysubstance use are more likely to use more substances or whether they have other characteristics that may impact child development.”

The authors noted that cannabis exposure has been linked to other neurodevelopmental outcomes, including reduced executive and motor function in infants. ”Notably, although we did not find a significant independent association between cannabis exposure and ADHD, children exposed to both cannabis and opioids had a 23% greater risk than expected from either exposure individually,” they reported.

The researchers suggest that their findings provide data for considering harm reduction approaches that reduce use of any single substance during pregnancy. “Focusing on the most obviously harmful exposures may be a useful way to reduce the risk of ADHD,” they wrote. “Further work is needed to directly investigate this hypothesis and examine whether reduction in the use of any substance among those with polysubstance use could be acceptable compared with abstinence.”

In an invited commentary, Angela Lupattelli, PhD, and Nhung T. H. Trinh, PhD, both of the department of pharmacy at the University of Oslo, noted the methodological challenges of assessing exposures and associations from multiple different substances during pregnancy.

“First, how can we disentangle the consequences of individual and/or combined substance exposures during pregnancy from the underlying risks?” they asked. In addition to differences in baseline characteristic between those who use opioids or cannabis, Dr. Lupattelli and Dr. Trinh noted that other important unmeasured factors, such as genetics and family environment, may confound the effect size estimates for ADHD.

They also noted the need to consider intensity, dose, duration, and timing of substance use during pregnancy.

“Understanding the longer-term safety of substance use during pregnancy is paramount to inform prevention policy and shape counseling strategies. Observational studies, despite their limitations, are a necessary piece of the puzzle,” they wrote. “However, the study findings should be interpreted with caution, as the use of advanced analytical methods cannot overcome the unavailability of some important confounding factors and exposure information.”

The research was funded by the U.S. Department of Health and Human Services and the National Institutes of Health. The authors had no industry-related disclosures.

Children prenatally exposed to opioids alone have an increased risk of attention-deficit/hyperactivity disorder (ADHD), but interactions between opioids and both cannabis use and alcohol use were linked to varying levels of ADHD risk as well, according to findings published March 11 in JAMA Network Open.

While many prenatal exposure studies examine associations with one substance, the results of this case-control study “suggest that it is important to consider prenatal exposure to multiple substances and the interactions between these substances when counseling women regarding substance use during pregnancy,” wrote Henri M. Garrison-Desany of the Johns Hopkins University, Baltimore, and colleagues.

Using data from children in the prospective Boston Birth Cohort between 1998 and 2019, the researchers did a secondary analysis on the 3,138 children (50.4% of whom were male) with at least 2 years of follow-up, excluding children from multiple-gestation pregnancies, in vitro fertilization pregnancies, and deliveries involving major maternal trauma or major chromosomal anomalies. Mothers answered a questionnaire within 24-72 hours of delivery regarding their demographics, substance use, pregnancy history, and health status. Among the mothers, 58.6% were Black, 22.3% were Hispanic, 7.2% were White, 1.5% were Asian, and 10.4% were other races/ethnicities.

The children’s electronic medical records were used to identify those with ADHD diagnoses. The researchers did not assess prescription opioid exposure during pregnancy, but they based opioid exposure on mothers’ reports of recreationally using heroin or oxycodone, mothers’ reports of receiving methadone treatment, or a newborn diagnosis of neonatal abstinence syndrome or neonatal opioid withdrawal syndrome.

Just under a quarter of the women (24.2%) reported using at least one substance during pregnancy. After tobacco smoking (18.5%), the next most reported substances were alcohol (8.1%), cannabis (3.9%), and opioids (1.9%). With a median 12 years of follow-up, 15.5% of the children had been diagnosed with ADHD, most of whom (71.6%) were male.

Before considering interaction of different substances, children exposed to opioids had a little over twice the risk of ADHD (hazard ratio [HR], 2.19) compared to those with no prenatal substance exposure. Although neither cannabis nor alcohol was independently associated with ADHD, smoking had a 40% increased risk, and researchers found a 21% increase in risk of ADHD with each additional substance mothers used during pregnancy. The researchers had adjusted these findings for maternal age, race/ethnicity, marital status, educational level, annual household income, parity, number of perinatal visits, and general stress during pregnancy, based on a structured interview.

When the researchers considered all the substances together, opioid exposure increased risk of ADHD by 60% (HR, 1.6), opioids with cannabis increased risk by 42%, opioids with alcohol increased risk by 15%, and opioids with smoking increased risk by 17%.

”Our findings suggest opioids may interact with other substances (including cannabis), which may be particularly deleterious,” the researchers reported. “It is not clear whether this interaction is owing to biological or environmental factors, such as whether individuals with illicit polysubstance use are more likely to use more substances or whether they have other characteristics that may impact child development.”

The authors noted that cannabis exposure has been linked to other neurodevelopmental outcomes, including reduced executive and motor function in infants. ”Notably, although we did not find a significant independent association between cannabis exposure and ADHD, children exposed to both cannabis and opioids had a 23% greater risk than expected from either exposure individually,” they reported.

The researchers suggest that their findings provide data for considering harm reduction approaches that reduce use of any single substance during pregnancy. “Focusing on the most obviously harmful exposures may be a useful way to reduce the risk of ADHD,” they wrote. “Further work is needed to directly investigate this hypothesis and examine whether reduction in the use of any substance among those with polysubstance use could be acceptable compared with abstinence.”

In an invited commentary, Angela Lupattelli, PhD, and Nhung T. H. Trinh, PhD, both of the department of pharmacy at the University of Oslo, noted the methodological challenges of assessing exposures and associations from multiple different substances during pregnancy.

“First, how can we disentangle the consequences of individual and/or combined substance exposures during pregnancy from the underlying risks?” they asked. In addition to differences in baseline characteristic between those who use opioids or cannabis, Dr. Lupattelli and Dr. Trinh noted that other important unmeasured factors, such as genetics and family environment, may confound the effect size estimates for ADHD.

They also noted the need to consider intensity, dose, duration, and timing of substance use during pregnancy.

“Understanding the longer-term safety of substance use during pregnancy is paramount to inform prevention policy and shape counseling strategies. Observational studies, despite their limitations, are a necessary piece of the puzzle,” they wrote. “However, the study findings should be interpreted with caution, as the use of advanced analytical methods cannot overcome the unavailability of some important confounding factors and exposure information.”

The research was funded by the U.S. Department of Health and Human Services and the National Institutes of Health. The authors had no industry-related disclosures.

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‘Baby-friendly’ steps help women meet prenatal breastfeeding goals

Article Type
Changed
Wed, 03/09/2022 - 14:46

 

A first-ever study of the effect of evidence-based maternity care practices on prenatal breastfeeding intentions in women from low-income U.S. households shows that the use of “baby-friendly steps” during birth hospitalization made it possible for almost half to breastfeed exclusively for 1 month.

Analyses of national data from a longitudinal study of 1,080 women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) revealed that 47% were able to meet their prenatal intention to breastfeed without formula or other milk for at least 30 days.

The odds of meeting prenatal breastfeeding intentions more than quadrupled when babies received only breast milk (risk ratio, 4.4; 95% confidence interval, 3.4-5.7), the study showed. Breastfeeding within 1 hour of birth was also associated with greater likelihood of breastfeeding success (RR, 1.3; 95% CI, 1.0-1.6).

The study, led by Heather C. Hamner, PhD, MS, MPH, of the National Center for Chronic Disease Prevention and Health Promotion, , Atlanta, was reported online in Pediatrics.

“This study confirms the relationship between experiencing maternity care practices supportive of breastfeeding and meeting one’s breastfeeding intentions, and adds evidence specifically among low-income women, who are known to be at higher risk of not breastfeeding,” the study authors wrote.

Women from low-income households often face additional barriers to meeting their breastfeeding goals, including lack of access to professional lactation services, Dr. Hamner said in an interview. “We want physicians to know how important maternity care practices supportive of breastfeeding are to helping all women achieve their breastfeeding goals. Physicians can be champions for implementation of evidence-based maternity care practices in the hospitals and practices in which they work.”

Dr. Hamner emphasized that physicians need to discuss the importance of breastfeeding with patients and their families, brief them on what to expect in the maternity care setting, and ensure women are connected to lactation resources. The American Academy of Pediatrics is working to increase physician capacity to support breastfeeding through the Physician Engagement and Training Focused on Breastfeeding project.

For the study, Dr. Hamner and colleagues analyzed data from the longitudinal WIC Infant and Toddler Feeding Practices Study-2 (ITFPS-2), which assessed the impact of 6 steps from a 10-step maternity care protocol known as The Ten Steps To Successful Breastfeeding. These steps are part of the worldwide Baby-Friendly Hospital Initiative (BFHI), which has been shown to improve rates of breastfeeding initiation, duration, and exclusivity.

After adjusting for sociodemographic and other factors, the study authors estimated risk ratios for associations between each of six maternity care practices assessed in ITFPS-2 and the success of women who reported an intention to breastfeed exclusively for 1 month. The six steps included initiation of breastfeeding within 1 hour of birth (step 4), showing moms how to breastfeed and maintain lactation (step 5), giving no food or drink other than breast milk unless medically indicated (step 6), rooming-in (step 7), breastfeeding on demand (step 8), and giving no pacifiers (step 9).

The analyses showed that only steps 4 and 6 – initiating breastfeeding at birth and giving only breast milk – remained significantly associated with meeting breastfeeding intentions. The results also revealed a dose-response relationship between the number of baby steps experienced during birth hospitalization and the likelihood of meeting breastfeeding goals, a finding in keeping with previous studies. In women who experienced all six steps, for example, 76% were breastfeeding exclusively at 1 month, compared with 16% of those who experienced zero to two steps.

Although the dose-response relationship did not appear to differ significantly by race or ethnicity, it was driven primarily by a hospital policy of providing infant formula or other supplementation, the study authors found. Notably, 44% of women reported that their infant had been fed something other than breast milk while in the hospital, and about 60% said they stopped breastfeeding earlier than intended.

“This finding reiterates the importance of limiting in-hospital formula or other supplementation of breastfed infants to only those with medical necessity,” Dr. Hamner and colleagues said.

Despite improvements in maternity care practices that promote breastfeeding, including an increase in the number of births occurring in U.S. hospitals with a baby-friendly designation, many women continue to experience significant barriers to breastfeeding, the investigators pointed out. Currently, there are 592 baby-friendly hospitals in the United States, representing 28.29% of annual births.

“I think more hospitals becoming baby friendly would really help,” Mary Franklin, DNP, CNM, assistant professor at Case Western Reserve University, Cleveland, said in an interview. More needs to be done to support women during birth hospitalization and after they return home, so they can continue to breastfeed for “longer than the initial 6 weeks,” added Dr. Franklin, who is also director of the nurse midwifery and women’s health NP program.

The AAP recommends exclusive breastfeeding for about 6 months followed by complementary food introduction and continued breastfeeding through 12 months or beyond.

Like Dr. Hamner, Dr. Franklin emphasized that physicians have an important role to play in the initiation, duration, and exclusivity of breastfeeding. This includes promoting enrichment of the pregnancy experience with prenatal education and increased support from health care providers and peers. At delivery, obstetricians can delay cord clamping to facilitate early breastfeeding. They can also support the elimination of the central nursery in hospitals so that mother and baby stay together from birth. In addition, prescriptions can be written for breast pumps, which are covered by Medicaid.

The study received no outside funding. Dr. Hamner and coauthors disclosed having no potential financial conflicts of interest. Dr. Franklin also disclosed having no financial conflicts of interest.

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A first-ever study of the effect of evidence-based maternity care practices on prenatal breastfeeding intentions in women from low-income U.S. households shows that the use of “baby-friendly steps” during birth hospitalization made it possible for almost half to breastfeed exclusively for 1 month.

Analyses of national data from a longitudinal study of 1,080 women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) revealed that 47% were able to meet their prenatal intention to breastfeed without formula or other milk for at least 30 days.

The odds of meeting prenatal breastfeeding intentions more than quadrupled when babies received only breast milk (risk ratio, 4.4; 95% confidence interval, 3.4-5.7), the study showed. Breastfeeding within 1 hour of birth was also associated with greater likelihood of breastfeeding success (RR, 1.3; 95% CI, 1.0-1.6).

The study, led by Heather C. Hamner, PhD, MS, MPH, of the National Center for Chronic Disease Prevention and Health Promotion, , Atlanta, was reported online in Pediatrics.

“This study confirms the relationship between experiencing maternity care practices supportive of breastfeeding and meeting one’s breastfeeding intentions, and adds evidence specifically among low-income women, who are known to be at higher risk of not breastfeeding,” the study authors wrote.

Women from low-income households often face additional barriers to meeting their breastfeeding goals, including lack of access to professional lactation services, Dr. Hamner said in an interview. “We want physicians to know how important maternity care practices supportive of breastfeeding are to helping all women achieve their breastfeeding goals. Physicians can be champions for implementation of evidence-based maternity care practices in the hospitals and practices in which they work.”

Dr. Hamner emphasized that physicians need to discuss the importance of breastfeeding with patients and their families, brief them on what to expect in the maternity care setting, and ensure women are connected to lactation resources. The American Academy of Pediatrics is working to increase physician capacity to support breastfeeding through the Physician Engagement and Training Focused on Breastfeeding project.

For the study, Dr. Hamner and colleagues analyzed data from the longitudinal WIC Infant and Toddler Feeding Practices Study-2 (ITFPS-2), which assessed the impact of 6 steps from a 10-step maternity care protocol known as The Ten Steps To Successful Breastfeeding. These steps are part of the worldwide Baby-Friendly Hospital Initiative (BFHI), which has been shown to improve rates of breastfeeding initiation, duration, and exclusivity.

After adjusting for sociodemographic and other factors, the study authors estimated risk ratios for associations between each of six maternity care practices assessed in ITFPS-2 and the success of women who reported an intention to breastfeed exclusively for 1 month. The six steps included initiation of breastfeeding within 1 hour of birth (step 4), showing moms how to breastfeed and maintain lactation (step 5), giving no food or drink other than breast milk unless medically indicated (step 6), rooming-in (step 7), breastfeeding on demand (step 8), and giving no pacifiers (step 9).

The analyses showed that only steps 4 and 6 – initiating breastfeeding at birth and giving only breast milk – remained significantly associated with meeting breastfeeding intentions. The results also revealed a dose-response relationship between the number of baby steps experienced during birth hospitalization and the likelihood of meeting breastfeeding goals, a finding in keeping with previous studies. In women who experienced all six steps, for example, 76% were breastfeeding exclusively at 1 month, compared with 16% of those who experienced zero to two steps.

Although the dose-response relationship did not appear to differ significantly by race or ethnicity, it was driven primarily by a hospital policy of providing infant formula or other supplementation, the study authors found. Notably, 44% of women reported that their infant had been fed something other than breast milk while in the hospital, and about 60% said they stopped breastfeeding earlier than intended.

“This finding reiterates the importance of limiting in-hospital formula or other supplementation of breastfed infants to only those with medical necessity,” Dr. Hamner and colleagues said.

Despite improvements in maternity care practices that promote breastfeeding, including an increase in the number of births occurring in U.S. hospitals with a baby-friendly designation, many women continue to experience significant barriers to breastfeeding, the investigators pointed out. Currently, there are 592 baby-friendly hospitals in the United States, representing 28.29% of annual births.

“I think more hospitals becoming baby friendly would really help,” Mary Franklin, DNP, CNM, assistant professor at Case Western Reserve University, Cleveland, said in an interview. More needs to be done to support women during birth hospitalization and after they return home, so they can continue to breastfeed for “longer than the initial 6 weeks,” added Dr. Franklin, who is also director of the nurse midwifery and women’s health NP program.

The AAP recommends exclusive breastfeeding for about 6 months followed by complementary food introduction and continued breastfeeding through 12 months or beyond.

Like Dr. Hamner, Dr. Franklin emphasized that physicians have an important role to play in the initiation, duration, and exclusivity of breastfeeding. This includes promoting enrichment of the pregnancy experience with prenatal education and increased support from health care providers and peers. At delivery, obstetricians can delay cord clamping to facilitate early breastfeeding. They can also support the elimination of the central nursery in hospitals so that mother and baby stay together from birth. In addition, prescriptions can be written for breast pumps, which are covered by Medicaid.

The study received no outside funding. Dr. Hamner and coauthors disclosed having no potential financial conflicts of interest. Dr. Franklin also disclosed having no financial conflicts of interest.

 

A first-ever study of the effect of evidence-based maternity care practices on prenatal breastfeeding intentions in women from low-income U.S. households shows that the use of “baby-friendly steps” during birth hospitalization made it possible for almost half to breastfeed exclusively for 1 month.

Analyses of national data from a longitudinal study of 1,080 women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) revealed that 47% were able to meet their prenatal intention to breastfeed without formula or other milk for at least 30 days.

The odds of meeting prenatal breastfeeding intentions more than quadrupled when babies received only breast milk (risk ratio, 4.4; 95% confidence interval, 3.4-5.7), the study showed. Breastfeeding within 1 hour of birth was also associated with greater likelihood of breastfeeding success (RR, 1.3; 95% CI, 1.0-1.6).

The study, led by Heather C. Hamner, PhD, MS, MPH, of the National Center for Chronic Disease Prevention and Health Promotion, , Atlanta, was reported online in Pediatrics.

“This study confirms the relationship between experiencing maternity care practices supportive of breastfeeding and meeting one’s breastfeeding intentions, and adds evidence specifically among low-income women, who are known to be at higher risk of not breastfeeding,” the study authors wrote.

Women from low-income households often face additional barriers to meeting their breastfeeding goals, including lack of access to professional lactation services, Dr. Hamner said in an interview. “We want physicians to know how important maternity care practices supportive of breastfeeding are to helping all women achieve their breastfeeding goals. Physicians can be champions for implementation of evidence-based maternity care practices in the hospitals and practices in which they work.”

Dr. Hamner emphasized that physicians need to discuss the importance of breastfeeding with patients and their families, brief them on what to expect in the maternity care setting, and ensure women are connected to lactation resources. The American Academy of Pediatrics is working to increase physician capacity to support breastfeeding through the Physician Engagement and Training Focused on Breastfeeding project.

For the study, Dr. Hamner and colleagues analyzed data from the longitudinal WIC Infant and Toddler Feeding Practices Study-2 (ITFPS-2), which assessed the impact of 6 steps from a 10-step maternity care protocol known as The Ten Steps To Successful Breastfeeding. These steps are part of the worldwide Baby-Friendly Hospital Initiative (BFHI), which has been shown to improve rates of breastfeeding initiation, duration, and exclusivity.

After adjusting for sociodemographic and other factors, the study authors estimated risk ratios for associations between each of six maternity care practices assessed in ITFPS-2 and the success of women who reported an intention to breastfeed exclusively for 1 month. The six steps included initiation of breastfeeding within 1 hour of birth (step 4), showing moms how to breastfeed and maintain lactation (step 5), giving no food or drink other than breast milk unless medically indicated (step 6), rooming-in (step 7), breastfeeding on demand (step 8), and giving no pacifiers (step 9).

The analyses showed that only steps 4 and 6 – initiating breastfeeding at birth and giving only breast milk – remained significantly associated with meeting breastfeeding intentions. The results also revealed a dose-response relationship between the number of baby steps experienced during birth hospitalization and the likelihood of meeting breastfeeding goals, a finding in keeping with previous studies. In women who experienced all six steps, for example, 76% were breastfeeding exclusively at 1 month, compared with 16% of those who experienced zero to two steps.

Although the dose-response relationship did not appear to differ significantly by race or ethnicity, it was driven primarily by a hospital policy of providing infant formula or other supplementation, the study authors found. Notably, 44% of women reported that their infant had been fed something other than breast milk while in the hospital, and about 60% said they stopped breastfeeding earlier than intended.

“This finding reiterates the importance of limiting in-hospital formula or other supplementation of breastfed infants to only those with medical necessity,” Dr. Hamner and colleagues said.

Despite improvements in maternity care practices that promote breastfeeding, including an increase in the number of births occurring in U.S. hospitals with a baby-friendly designation, many women continue to experience significant barriers to breastfeeding, the investigators pointed out. Currently, there are 592 baby-friendly hospitals in the United States, representing 28.29% of annual births.

“I think more hospitals becoming baby friendly would really help,” Mary Franklin, DNP, CNM, assistant professor at Case Western Reserve University, Cleveland, said in an interview. More needs to be done to support women during birth hospitalization and after they return home, so they can continue to breastfeed for “longer than the initial 6 weeks,” added Dr. Franklin, who is also director of the nurse midwifery and women’s health NP program.

The AAP recommends exclusive breastfeeding for about 6 months followed by complementary food introduction and continued breastfeeding through 12 months or beyond.

Like Dr. Hamner, Dr. Franklin emphasized that physicians have an important role to play in the initiation, duration, and exclusivity of breastfeeding. This includes promoting enrichment of the pregnancy experience with prenatal education and increased support from health care providers and peers. At delivery, obstetricians can delay cord clamping to facilitate early breastfeeding. They can also support the elimination of the central nursery in hospitals so that mother and baby stay together from birth. In addition, prescriptions can be written for breast pumps, which are covered by Medicaid.

The study received no outside funding. Dr. Hamner and coauthors disclosed having no potential financial conflicts of interest. Dr. Franklin also disclosed having no financial conflicts of interest.

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Phthalate exposure via maternal and cord blood affects infant outcomes

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Tue, 03/01/2022 - 14:30

 

Exposure to phthalates through maternal blood and cord blood affected outcomes including head circumference and anogenital index for male and female infants, according to data from 65 mother-infant pairs.

Phthalates are recognized endocrine disruptors that have been associated with adverse birth outcomes, but the specific relationship between maternal phthalate exposure and birth outcomes has not been well studied, wrote Hsiao-Lin Hwa, MD, of National Taiwan University, Taipei, and colleagues.

Previous research suggests that trace exposure to hazardous chemicals during the fetal period “may cause fetal metabolic dysfunction and adversely change the morphology of body systems,” they said. In 2011, “the Taiwan Food and Drug Administration found that di‐2‐ethylhexyl phthalate (DEHP) and DiNP [di‐isononyl phthalate] had been illegally added as emulsifiers to replace palm oil in beverages and food,” they added. The researchers sought to examine the association between infant birth outcomes and phthalate exposure levels in the Taiwanese population after 2011. In a study published in Environmental Toxicology and Chemistry, the researchers recruited 65 pregnant women in Taiwan between 2016 and 2017. Birth length, birth weight, head circumference, anogenital distance (AGD), anoscrotal distance (ASD), and anofourchette distance (AFD) were measured for each newborn at the time of delivery. The average age of the women was 33.6 years, and the rate of low birth weight was 13.7%. The mean measures of birth length, birth weight, head circumference, and chest circumference were 47.6 cm, 3022 g, 32.9 cm, and 30.8 mm, respectively. The mean AFD and ASD were 14.2 mm and 22.3 mm, respectively.

The researchers tested for 12 phthalates in maternal blood and cord blood samples. Of these, the six most frequently detected phthalate metabolites were mono‐ethyl phthalate (MEP), mono‐isobutyl phthalate (MiBP), mono‐n‐butyl phthalate (MnBP), mono‐(2‐ethyl‐5‐oxohexyl)‐phthalate (MEOHP), mono‐(2‐ethyl‐5‐hydroxyhexyl) phthalate (MEHHP), and mono‐n‐octyl phthalate (MOP); these six were present in 80%–100% of the maternal blood samples.

Overall, the mean levels of MEP, MiBP, MnBP, and MEHP were relatively higher in both maternal and infant blood than other phthalates, the researchers noted. The mean concentrations of metabolites in maternal blood and infant cord blood were 0.03-2.27 ng/mL and 0.01-3.74 ng/mL, respectively.

Among male infants, levels of MMP, MiBP, and MEHP in maternal blood were inversely related to anogenital index (AGI), with P values for regression coefficients ranging from .011 to .033. In addition, the total concentration of MEHP, MEOHP, and MEHHP (designated as Σdi‐2‐ethylhexyl phthalate, ΣDEHP) was inversely related to AGI in males.

Among female infants, however, phthalates in cord blood, rather than maternal blood, were positively related to AGI, including MMP, MibP, MnBP, and MOP, with P values for regression coefficients ranging from .001 to .034.

Cord blood levels of MnBP, MEOHP, MEHP, and ΣDEHP were inversely associated with gestational age-adjusted head circumference in all infants, with beta coefficients of –0.15, –0.12, –0.01, and –0.01, respectively (P < .05 for all).

“The detection rates of MEHHP, MEOHP, and MEHP in the cord blood were lower than those in the maternal blood, particularly those of MEHHP and MEOHP, which were approximately 25% lower,” which may be caused by slow placental transfer, the researchers wrote in their discussion section. “The high detection rate of phthalate metabolites indicated that our subjects may continue to be exposed to these phthalates even after the 2011 Taiwan DEHP incident,” they noted.

The study findings were limited by several factors including the possibility for contamination of samples and other environmental confounders, the researchers noted. However, the results support the role of phthalates as endocrine disruptors, and the distinction in effects between males and females “may suggest that phthalate monoesters are potentially estrogenic and antiandrogenic chemicals,” they added.

“Further investigations involving multiple phthalate analyses during pregnancy and measurements throughout childhood are necessary to confirm our findings,” they concluded.
 

 

 

Direct clinical implications remain uncertain

“Phthalates are a group of chemicals that are used to make plastic more durable; they are found in multiple everyday materials, food products, and common household products,” Marissa Platner, MD, of Emory University, Atlanta, said in an interview. “It is known that we are exposed to phthalates on a routine basis but the long-term effects of this exposure are unclear,” she said.

Dr. Marissa Platner

The current study findings “were not entirely surprising given data from prior animal studies because they do imply that there is some placental transfer of the phthalate metabolites that can cause adverse effects on the developing fetus,” said Dr. Platner. “However, they also demonstrate that the placenta acts as a filter for certain larger molecules to protect the fetus,” she said.

“This study was based on a small sample size, therefore the clinical implications are not clear,” Dr. Platner noted. “However it may be worthwhile after further research to encourage our pregnant patients to try to decrease their exposure to phthalates,” she said.

Dr. Platner identified two areas for additional research to explore the role of phthalate exposure.

“The first would be to assess the level of maternal phthalate exposure throughout the pregnancy instead of just at one point in time, and the second would be to assess how the reproductive system differences at birth translate to long-term outcomes in children, such as early puberty in females or decreased fertility in males,” she said.  

The study was funded by the Ministry of Science and Technology of Taiwan and the Far Eastern Memorial Hospital‐National Taiwan University Hospital. The researchers and Dr. Platner had no financial conflicts to disclose.

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Exposure to phthalates through maternal blood and cord blood affected outcomes including head circumference and anogenital index for male and female infants, according to data from 65 mother-infant pairs.

Phthalates are recognized endocrine disruptors that have been associated with adverse birth outcomes, but the specific relationship between maternal phthalate exposure and birth outcomes has not been well studied, wrote Hsiao-Lin Hwa, MD, of National Taiwan University, Taipei, and colleagues.

Previous research suggests that trace exposure to hazardous chemicals during the fetal period “may cause fetal metabolic dysfunction and adversely change the morphology of body systems,” they said. In 2011, “the Taiwan Food and Drug Administration found that di‐2‐ethylhexyl phthalate (DEHP) and DiNP [di‐isononyl phthalate] had been illegally added as emulsifiers to replace palm oil in beverages and food,” they added. The researchers sought to examine the association between infant birth outcomes and phthalate exposure levels in the Taiwanese population after 2011. In a study published in Environmental Toxicology and Chemistry, the researchers recruited 65 pregnant women in Taiwan between 2016 and 2017. Birth length, birth weight, head circumference, anogenital distance (AGD), anoscrotal distance (ASD), and anofourchette distance (AFD) were measured for each newborn at the time of delivery. The average age of the women was 33.6 years, and the rate of low birth weight was 13.7%. The mean measures of birth length, birth weight, head circumference, and chest circumference were 47.6 cm, 3022 g, 32.9 cm, and 30.8 mm, respectively. The mean AFD and ASD were 14.2 mm and 22.3 mm, respectively.

The researchers tested for 12 phthalates in maternal blood and cord blood samples. Of these, the six most frequently detected phthalate metabolites were mono‐ethyl phthalate (MEP), mono‐isobutyl phthalate (MiBP), mono‐n‐butyl phthalate (MnBP), mono‐(2‐ethyl‐5‐oxohexyl)‐phthalate (MEOHP), mono‐(2‐ethyl‐5‐hydroxyhexyl) phthalate (MEHHP), and mono‐n‐octyl phthalate (MOP); these six were present in 80%–100% of the maternal blood samples.

Overall, the mean levels of MEP, MiBP, MnBP, and MEHP were relatively higher in both maternal and infant blood than other phthalates, the researchers noted. The mean concentrations of metabolites in maternal blood and infant cord blood were 0.03-2.27 ng/mL and 0.01-3.74 ng/mL, respectively.

Among male infants, levels of MMP, MiBP, and MEHP in maternal blood were inversely related to anogenital index (AGI), with P values for regression coefficients ranging from .011 to .033. In addition, the total concentration of MEHP, MEOHP, and MEHHP (designated as Σdi‐2‐ethylhexyl phthalate, ΣDEHP) was inversely related to AGI in males.

Among female infants, however, phthalates in cord blood, rather than maternal blood, were positively related to AGI, including MMP, MibP, MnBP, and MOP, with P values for regression coefficients ranging from .001 to .034.

Cord blood levels of MnBP, MEOHP, MEHP, and ΣDEHP were inversely associated with gestational age-adjusted head circumference in all infants, with beta coefficients of –0.15, –0.12, –0.01, and –0.01, respectively (P < .05 for all).

“The detection rates of MEHHP, MEOHP, and MEHP in the cord blood were lower than those in the maternal blood, particularly those of MEHHP and MEOHP, which were approximately 25% lower,” which may be caused by slow placental transfer, the researchers wrote in their discussion section. “The high detection rate of phthalate metabolites indicated that our subjects may continue to be exposed to these phthalates even after the 2011 Taiwan DEHP incident,” they noted.

The study findings were limited by several factors including the possibility for contamination of samples and other environmental confounders, the researchers noted. However, the results support the role of phthalates as endocrine disruptors, and the distinction in effects between males and females “may suggest that phthalate monoesters are potentially estrogenic and antiandrogenic chemicals,” they added.

“Further investigations involving multiple phthalate analyses during pregnancy and measurements throughout childhood are necessary to confirm our findings,” they concluded.
 

 

 

Direct clinical implications remain uncertain

“Phthalates are a group of chemicals that are used to make plastic more durable; they are found in multiple everyday materials, food products, and common household products,” Marissa Platner, MD, of Emory University, Atlanta, said in an interview. “It is known that we are exposed to phthalates on a routine basis but the long-term effects of this exposure are unclear,” she said.

Dr. Marissa Platner

The current study findings “were not entirely surprising given data from prior animal studies because they do imply that there is some placental transfer of the phthalate metabolites that can cause adverse effects on the developing fetus,” said Dr. Platner. “However, they also demonstrate that the placenta acts as a filter for certain larger molecules to protect the fetus,” she said.

“This study was based on a small sample size, therefore the clinical implications are not clear,” Dr. Platner noted. “However it may be worthwhile after further research to encourage our pregnant patients to try to decrease their exposure to phthalates,” she said.

Dr. Platner identified two areas for additional research to explore the role of phthalate exposure.

“The first would be to assess the level of maternal phthalate exposure throughout the pregnancy instead of just at one point in time, and the second would be to assess how the reproductive system differences at birth translate to long-term outcomes in children, such as early puberty in females or decreased fertility in males,” she said.  

The study was funded by the Ministry of Science and Technology of Taiwan and the Far Eastern Memorial Hospital‐National Taiwan University Hospital. The researchers and Dr. Platner had no financial conflicts to disclose.

 

Exposure to phthalates through maternal blood and cord blood affected outcomes including head circumference and anogenital index for male and female infants, according to data from 65 mother-infant pairs.

Phthalates are recognized endocrine disruptors that have been associated with adverse birth outcomes, but the specific relationship between maternal phthalate exposure and birth outcomes has not been well studied, wrote Hsiao-Lin Hwa, MD, of National Taiwan University, Taipei, and colleagues.

Previous research suggests that trace exposure to hazardous chemicals during the fetal period “may cause fetal metabolic dysfunction and adversely change the morphology of body systems,” they said. In 2011, “the Taiwan Food and Drug Administration found that di‐2‐ethylhexyl phthalate (DEHP) and DiNP [di‐isononyl phthalate] had been illegally added as emulsifiers to replace palm oil in beverages and food,” they added. The researchers sought to examine the association between infant birth outcomes and phthalate exposure levels in the Taiwanese population after 2011. In a study published in Environmental Toxicology and Chemistry, the researchers recruited 65 pregnant women in Taiwan between 2016 and 2017. Birth length, birth weight, head circumference, anogenital distance (AGD), anoscrotal distance (ASD), and anofourchette distance (AFD) were measured for each newborn at the time of delivery. The average age of the women was 33.6 years, and the rate of low birth weight was 13.7%. The mean measures of birth length, birth weight, head circumference, and chest circumference were 47.6 cm, 3022 g, 32.9 cm, and 30.8 mm, respectively. The mean AFD and ASD were 14.2 mm and 22.3 mm, respectively.

The researchers tested for 12 phthalates in maternal blood and cord blood samples. Of these, the six most frequently detected phthalate metabolites were mono‐ethyl phthalate (MEP), mono‐isobutyl phthalate (MiBP), mono‐n‐butyl phthalate (MnBP), mono‐(2‐ethyl‐5‐oxohexyl)‐phthalate (MEOHP), mono‐(2‐ethyl‐5‐hydroxyhexyl) phthalate (MEHHP), and mono‐n‐octyl phthalate (MOP); these six were present in 80%–100% of the maternal blood samples.

Overall, the mean levels of MEP, MiBP, MnBP, and MEHP were relatively higher in both maternal and infant blood than other phthalates, the researchers noted. The mean concentrations of metabolites in maternal blood and infant cord blood were 0.03-2.27 ng/mL and 0.01-3.74 ng/mL, respectively.

Among male infants, levels of MMP, MiBP, and MEHP in maternal blood were inversely related to anogenital index (AGI), with P values for regression coefficients ranging from .011 to .033. In addition, the total concentration of MEHP, MEOHP, and MEHHP (designated as Σdi‐2‐ethylhexyl phthalate, ΣDEHP) was inversely related to AGI in males.

Among female infants, however, phthalates in cord blood, rather than maternal blood, were positively related to AGI, including MMP, MibP, MnBP, and MOP, with P values for regression coefficients ranging from .001 to .034.

Cord blood levels of MnBP, MEOHP, MEHP, and ΣDEHP were inversely associated with gestational age-adjusted head circumference in all infants, with beta coefficients of –0.15, –0.12, –0.01, and –0.01, respectively (P < .05 for all).

“The detection rates of MEHHP, MEOHP, and MEHP in the cord blood were lower than those in the maternal blood, particularly those of MEHHP and MEOHP, which were approximately 25% lower,” which may be caused by slow placental transfer, the researchers wrote in their discussion section. “The high detection rate of phthalate metabolites indicated that our subjects may continue to be exposed to these phthalates even after the 2011 Taiwan DEHP incident,” they noted.

The study findings were limited by several factors including the possibility for contamination of samples and other environmental confounders, the researchers noted. However, the results support the role of phthalates as endocrine disruptors, and the distinction in effects between males and females “may suggest that phthalate monoesters are potentially estrogenic and antiandrogenic chemicals,” they added.

“Further investigations involving multiple phthalate analyses during pregnancy and measurements throughout childhood are necessary to confirm our findings,” they concluded.
 

 

 

Direct clinical implications remain uncertain

“Phthalates are a group of chemicals that are used to make plastic more durable; they are found in multiple everyday materials, food products, and common household products,” Marissa Platner, MD, of Emory University, Atlanta, said in an interview. “It is known that we are exposed to phthalates on a routine basis but the long-term effects of this exposure are unclear,” she said.

Dr. Marissa Platner

The current study findings “were not entirely surprising given data from prior animal studies because they do imply that there is some placental transfer of the phthalate metabolites that can cause adverse effects on the developing fetus,” said Dr. Platner. “However, they also demonstrate that the placenta acts as a filter for certain larger molecules to protect the fetus,” she said.

“This study was based on a small sample size, therefore the clinical implications are not clear,” Dr. Platner noted. “However it may be worthwhile after further research to encourage our pregnant patients to try to decrease their exposure to phthalates,” she said.

Dr. Platner identified two areas for additional research to explore the role of phthalate exposure.

“The first would be to assess the level of maternal phthalate exposure throughout the pregnancy instead of just at one point in time, and the second would be to assess how the reproductive system differences at birth translate to long-term outcomes in children, such as early puberty in females or decreased fertility in males,” she said.  

The study was funded by the Ministry of Science and Technology of Taiwan and the Far Eastern Memorial Hospital‐National Taiwan University Hospital. The researchers and Dr. Platner had no financial conflicts to disclose.

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