Pediatrics

Overwhelming numbers of early puberty cases among girls have been reported during the pandemic, according a report copublished by the Washington Post and The Fuller Project.

Early puberty is uncommon, affecting about 1 in every 5,000 to 10,000 children, with cases about 10 times higher in girls than boys. But since the pandemic started, doctors and parents around the world have noted a substantial surge in early puberty.

In some cases, girls as young as 5 have begun developing breasts and girls younger than 8 have started menstruation.

“I noticed that quite a few of my [girl patients] got their period after a lockdown,” Adiaha Spinks-Franklin, MD, a pediatrician at Texas Children’s Hospital, Houston, told the news outlets.

The condition, also called precocious puberty, is defined as puberty-related changes earlier than normal or expected, which starts around age 8 for girls and age 9 for boys. It can sometimes be caused by genetic syndromes, central nervous system issues, or tumors on the ovaries, adrenal glands, pituitary gland, or brain.

Pediatricians across the world have reported more precocious puberty cases, the news outlets reported, including in the United States, India, Italy, and Turkey.

A recent study found that more than 300 girls were referred to five pediatric endocrinology centers in Italy between March and September 2020, as opposed to 140 referrals during the same time period in 2019.

In another study, a Turkish pediatric endocrinology clinic reported 58 cases during the first year of the pandemic, as compared with 66 total cases during the 3 previous years.

Early puberty tends to mean there are other mental and physical issues, though in most cases, an exact cause can’t be found. Doctors have tied the current uptick to the stress of the pandemic and lockdowns, including reduced physical activity and increased consumption of unhealthy food, which are things linked to a higher risk of early puberty.

“I think it’s directly related to the amount of stress that the children have gone through,” Vaishakhi Rustagi, MD, a pediatric endocrinologist in Delhi, India, told the news outlets.

In a typical year, Dr. Rustagi sees about 20 patients with early puberty. Since mid-2020, she’s seen more than 300 girls with the condition. Imaging scans and ultrasounds haven’t found tumors, and the cause has been mostly unidentifiable, though Dr. Rustagi attributed it to stress and grief.

“These children have lost family members,” she said.

Early puberty is known to increase depression, eating disorders, substance abuse, and antisocial behavior, the news outlets reported.

The main treatment for the condition, a form of hormone therapy known as gonadotropin-releasing hormone analogue therapy, is known to work very well. But some patients and families may not seek treatment because of a lack of awareness or stigmas that come with menstruation.

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

Overwhelming numbers of early puberty cases among girls have been reported during the pandemic, according a report copublished by the Washington Post and The Fuller Project.

Early puberty is uncommon, affecting about 1 in every 5,000 to 10,000 children, with cases about 10 times higher in girls than boys. But since the pandemic started, doctors and parents around the world have noted a substantial surge in early puberty.

In some cases, girls as young as 5 have begun developing breasts and girls younger than 8 have started menstruation.

“I noticed that quite a few of my [girl patients] got their period after a lockdown,” Adiaha Spinks-Franklin, MD, a pediatrician at Texas Children’s Hospital, Houston, told the news outlets.

The condition, also called precocious puberty, is defined as puberty-related changes earlier than normal or expected, which starts around age 8 for girls and age 9 for boys. It can sometimes be caused by genetic syndromes, central nervous system issues, or tumors on the ovaries, adrenal glands, pituitary gland, or brain.

Pediatricians across the world have reported more precocious puberty cases, the news outlets reported, including in the United States, India, Italy, and Turkey.

A recent study found that more than 300 girls were referred to five pediatric endocrinology centers in Italy between March and September 2020, as opposed to 140 referrals during the same time period in 2019.

In another study, a Turkish pediatric endocrinology clinic reported 58 cases during the first year of the pandemic, as compared with 66 total cases during the 3 previous years.

Early puberty tends to mean there are other mental and physical issues, though in most cases, an exact cause can’t be found. Doctors have tied the current uptick to the stress of the pandemic and lockdowns, including reduced physical activity and increased consumption of unhealthy food, which are things linked to a higher risk of early puberty.

“I think it’s directly related to the amount of stress that the children have gone through,” Vaishakhi Rustagi, MD, a pediatric endocrinologist in Delhi, India, told the news outlets.

In a typical year, Dr. Rustagi sees about 20 patients with early puberty. Since mid-2020, she’s seen more than 300 girls with the condition. Imaging scans and ultrasounds haven’t found tumors, and the cause has been mostly unidentifiable, though Dr. Rustagi attributed it to stress and grief.

“These children have lost family members,” she said.

Early puberty is known to increase depression, eating disorders, substance abuse, and antisocial behavior, the news outlets reported.

The main treatment for the condition, a form of hormone therapy known as gonadotropin-releasing hormone analogue therapy, is known to work very well. But some patients and families may not seek treatment because of a lack of awareness or stigmas that come with menstruation.

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

Overwhelming numbers of early puberty cases among girls have been reported during the pandemic, according a report copublished by the Washington Post and The Fuller Project.

Early puberty is uncommon, affecting about 1 in every 5,000 to 10,000 children, with cases about 10 times higher in girls than boys. But since the pandemic started, doctors and parents around the world have noted a substantial surge in early puberty.

In some cases, girls as young as 5 have begun developing breasts and girls younger than 8 have started menstruation.

“I noticed that quite a few of my [girl patients] got their period after a lockdown,” Adiaha Spinks-Franklin, MD, a pediatrician at Texas Children’s Hospital, Houston, told the news outlets.

The condition, also called precocious puberty, is defined as puberty-related changes earlier than normal or expected, which starts around age 8 for girls and age 9 for boys. It can sometimes be caused by genetic syndromes, central nervous system issues, or tumors on the ovaries, adrenal glands, pituitary gland, or brain.

Pediatricians across the world have reported more precocious puberty cases, the news outlets reported, including in the United States, India, Italy, and Turkey.

A recent study found that more than 300 girls were referred to five pediatric endocrinology centers in Italy between March and September 2020, as opposed to 140 referrals during the same time period in 2019.

In another study, a Turkish pediatric endocrinology clinic reported 58 cases during the first year of the pandemic, as compared with 66 total cases during the 3 previous years.

Early puberty tends to mean there are other mental and physical issues, though in most cases, an exact cause can’t be found. Doctors have tied the current uptick to the stress of the pandemic and lockdowns, including reduced physical activity and increased consumption of unhealthy food, which are things linked to a higher risk of early puberty.

“I think it’s directly related to the amount of stress that the children have gone through,” Vaishakhi Rustagi, MD, a pediatric endocrinologist in Delhi, India, told the news outlets.

In a typical year, Dr. Rustagi sees about 20 patients with early puberty. Since mid-2020, she’s seen more than 300 girls with the condition. Imaging scans and ultrasounds haven’t found tumors, and the cause has been mostly unidentifiable, though Dr. Rustagi attributed it to stress and grief.

“These children have lost family members,” she said.

Early puberty is known to increase depression, eating disorders, substance abuse, and antisocial behavior, the news outlets reported.

The main treatment for the condition, a form of hormone therapy known as gonadotropin-releasing hormone analogue therapy, is known to work very well. But some patients and families may not seek treatment because of a lack of awareness or stigmas that come with menstruation.

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

On his last shift in the last hockey game of the regular season, our 14-year-old grandson broke his arm. Although this was his first fracture, the rest of the nuclear family has had ample experience with orthopedic trauma over the last year, both planned and unplanned.

As I drove Peter and my daughter-in-law to his first postsetting and casting appointment I told him how sorry I was that he had been told “no contact sports for the next 3 months.” This was a tough pill for a kid eager to begin his first high school lacrosse season. Then I asked him what the doctor had told him he could do in the way of activity.

Based on personal and professional experience I was not surprised when he told me that no one had suggested things he could be doing. In fact, being a cautious and thoughtful kid, he was concerned about what he should be doing around the house let alone any athletic activities. It turns out he wasn’t even lifting his laptop computer with two hands because some nurse had told him not to lift anything over 2 pounds.

I told him “Peter, even some of the most experienced doctors focus on the ‘can’ts’ and forget to tell you the ‘cans’ and ‘shoulds.’ While you’re in the waiting room make up a mental list of what you would like to be doing that you aren’t.”

As he climbed back in the car for the ride home I asked how the visit went. The x-ray showed good alignment and the doctor was pleased. But, as I predicted, they were already on the launch pad to the receptionist to make a follow-up appointment without the physician uttering a single word about what activities he could resume. Always a very coachable kid, Peter piped up with the list he had created in the waiting room and was relieved to hear that he could do anything as long as it didn’t hurt. In fact, the doctor encouraged him to use his fingers because it might speed the healing.

Not every patient, regardless of age, is as cautious as my grandson and in some circumstances the physician must err on the side of emphasizing the “don’ts.” However, in my experience, too many physicians forget to include a generous list of “can do’s” in their visit closing discussions. This oversight is a mistake for several reasons.

First, and maybe most importantly, even a brief discussion of “can do’s” can soften the depressing message that the patient will not be able to do things he or she enjoys. I can’t quote the references but I am sure there is plenty of evidence that depression slows the healing process.

Second, and this is particularly true in older patients with orthopedic problems – failure to include a plan for return to activity can hinder recovery. I can recall more than a few patients who were seen in the emergency department and diagnosed with sprains but not given even the simplest instructions on how to begin moving the injured joint. When they finally returned to see me we had to begin the painful and unnecessary project of thawing a frozen joint.

Fortunately, we have evolved past the era when best rest was near the top of the list of our recommended remedies. However, there still remains a bias against activity in some situations. The most recent example is the evolving strategies for the management of concussion. There is some evidence that involving the patient in a return to activity plan may shorten the time to recovery. The myth about brain rest has been slow to die.

Finally, providing the patient with a personalized list of “can do’s” makes good business sense because it can head off those time-gobbling call backs that tie up you and your office staff. As an experienced physician, you have probably learned the most frequently asked “Can Jason do ... ?” questions. Make your own list and give the patient your answers. An ounce of anticipatory guidance is worth hours on the telephone or sorting through the email inbox.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

On his last shift in the last hockey game of the regular season, our 14-year-old grandson broke his arm. Although this was his first fracture, the rest of the nuclear family has had ample experience with orthopedic trauma over the last year, both planned and unplanned.

As I drove Peter and my daughter-in-law to his first postsetting and casting appointment I told him how sorry I was that he had been told “no contact sports for the next 3 months.” This was a tough pill for a kid eager to begin his first high school lacrosse season. Then I asked him what the doctor had told him he could do in the way of activity.

Based on personal and professional experience I was not surprised when he told me that no one had suggested things he could be doing. In fact, being a cautious and thoughtful kid, he was concerned about what he should be doing around the house let alone any athletic activities. It turns out he wasn’t even lifting his laptop computer with two hands because some nurse had told him not to lift anything over 2 pounds.

I told him “Peter, even some of the most experienced doctors focus on the ‘can’ts’ and forget to tell you the ‘cans’ and ‘shoulds.’ While you’re in the waiting room make up a mental list of what you would like to be doing that you aren’t.”

As he climbed back in the car for the ride home I asked how the visit went. The x-ray showed good alignment and the doctor was pleased. But, as I predicted, they were already on the launch pad to the receptionist to make a follow-up appointment without the physician uttering a single word about what activities he could resume. Always a very coachable kid, Peter piped up with the list he had created in the waiting room and was relieved to hear that he could do anything as long as it didn’t hurt. In fact, the doctor encouraged him to use his fingers because it might speed the healing.

Not every patient, regardless of age, is as cautious as my grandson and in some circumstances the physician must err on the side of emphasizing the “don’ts.” However, in my experience, too many physicians forget to include a generous list of “can do’s” in their visit closing discussions. This oversight is a mistake for several reasons.

First, and maybe most importantly, even a brief discussion of “can do’s” can soften the depressing message that the patient will not be able to do things he or she enjoys. I can’t quote the references but I am sure there is plenty of evidence that depression slows the healing process.

Second, and this is particularly true in older patients with orthopedic problems – failure to include a plan for return to activity can hinder recovery. I can recall more than a few patients who were seen in the emergency department and diagnosed with sprains but not given even the simplest instructions on how to begin moving the injured joint. When they finally returned to see me we had to begin the painful and unnecessary project of thawing a frozen joint.

Fortunately, we have evolved past the era when best rest was near the top of the list of our recommended remedies. However, there still remains a bias against activity in some situations. The most recent example is the evolving strategies for the management of concussion. There is some evidence that involving the patient in a return to activity plan may shorten the time to recovery. The myth about brain rest has been slow to die.

Finally, providing the patient with a personalized list of “can do’s” makes good business sense because it can head off those time-gobbling call backs that tie up you and your office staff. As an experienced physician, you have probably learned the most frequently asked “Can Jason do ... ?” questions. Make your own list and give the patient your answers. An ounce of anticipatory guidance is worth hours on the telephone or sorting through the email inbox.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

On his last shift in the last hockey game of the regular season, our 14-year-old grandson broke his arm. Although this was his first fracture, the rest of the nuclear family has had ample experience with orthopedic trauma over the last year, both planned and unplanned.

As I drove Peter and my daughter-in-law to his first postsetting and casting appointment I told him how sorry I was that he had been told “no contact sports for the next 3 months.” This was a tough pill for a kid eager to begin his first high school lacrosse season. Then I asked him what the doctor had told him he could do in the way of activity.

Based on personal and professional experience I was not surprised when he told me that no one had suggested things he could be doing. In fact, being a cautious and thoughtful kid, he was concerned about what he should be doing around the house let alone any athletic activities. It turns out he wasn’t even lifting his laptop computer with two hands because some nurse had told him not to lift anything over 2 pounds.

I told him “Peter, even some of the most experienced doctors focus on the ‘can’ts’ and forget to tell you the ‘cans’ and ‘shoulds.’ While you’re in the waiting room make up a mental list of what you would like to be doing that you aren’t.”

As he climbed back in the car for the ride home I asked how the visit went. The x-ray showed good alignment and the doctor was pleased. But, as I predicted, they were already on the launch pad to the receptionist to make a follow-up appointment without the physician uttering a single word about what activities he could resume. Always a very coachable kid, Peter piped up with the list he had created in the waiting room and was relieved to hear that he could do anything as long as it didn’t hurt. In fact, the doctor encouraged him to use his fingers because it might speed the healing.

Not every patient, regardless of age, is as cautious as my grandson and in some circumstances the physician must err on the side of emphasizing the “don’ts.” However, in my experience, too many physicians forget to include a generous list of “can do’s” in their visit closing discussions. This oversight is a mistake for several reasons.

First, and maybe most importantly, even a brief discussion of “can do’s” can soften the depressing message that the patient will not be able to do things he or she enjoys. I can’t quote the references but I am sure there is plenty of evidence that depression slows the healing process.

Second, and this is particularly true in older patients with orthopedic problems – failure to include a plan for return to activity can hinder recovery. I can recall more than a few patients who were seen in the emergency department and diagnosed with sprains but not given even the simplest instructions on how to begin moving the injured joint. When they finally returned to see me we had to begin the painful and unnecessary project of thawing a frozen joint.

Fortunately, we have evolved past the era when best rest was near the top of the list of our recommended remedies. However, there still remains a bias against activity in some situations. The most recent example is the evolving strategies for the management of concussion. There is some evidence that involving the patient in a return to activity plan may shorten the time to recovery. The myth about brain rest has been slow to die.

Finally, providing the patient with a personalized list of “can do’s” makes good business sense because it can head off those time-gobbling call backs that tie up you and your office staff. As an experienced physician, you have probably learned the most frequently asked “Can Jason do ... ?” questions. Make your own list and give the patient your answers. An ounce of anticipatory guidance is worth hours on the telephone or sorting through the email inbox.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Intravenous gentamicin therapy was associated with new laminin 332 – a major component of anchoring filaments in the dermal-epidermal junction – in the skin of five pediatric patients with intermediate or severe junctional epidermolysis bullosa (JEB) caused by nonsense variants.

The newly generated structural protein persisted during the 3-month randomized clinical trial and was associated with significant wound closure – with no signs of ototoxic effects, nephrotoxic effects, or anti–laminin 332 autoantibody induction, investigators recently reported in JAMA Dermatology.

JEB is a rare, autosomal recessive disorder caused mainly by nonsense variants (i.e., mutations) in the LAMA3, LAMB3, or LAMC2 genes that encode laminin, resulting in widespread blisters and erosions of the skin. Current treatment is limited to supportive management and palliative care, and children with its severe subtype are likely to die within the first year of life.

“With data indicating a robust response to short-term gentamicin treatment and the marked stability of laminin 332, we envision that gentamicin could be delivered as a short-term pulse therapy every 2-3 months for patients with JEB caused by nonsense variants,” the researchers wrote.

Of the five patients, ages 3 months to 10 years, three received 7.5 mg/kg IV gentamicin daily for 14 days, and two received 10 mg/kg daily for 24 days at the University of Southern California, Los Angeles.

All had confirmed nonsense variants in LAMA3 or LAMB3 in one or two alleles, and all had minimal laminin 332 expression at baseline as determined by immunofluorescence. After treatment, each of the children had increased, sustained expression of laminin 332.

The researchers monitored three open wounds in each patient. By 1 month, seven of nine wounds in those receiving the lower-dose therapy and all of the wounds in those receiving the higher-dose therapy showed at least 50% closure. By 3 months, eight of nine wounds in the lower-dose group, and all wounds in the higher-dose group showed greater than 85% closure.

In an interview, senior investigators Mei Chen, PhD, professor of dermatology, and David T. Woodley, MD, professor and chair of dermatology, both at USC, emphasized laminin’s long half-life.“Once these skin structural proteins are generated at the dermal-epidermal junction, they are long-lasting structures, which means the therapy can be pulsed rather than continuously delivered, which can obviate some of the known side effects of the medication,” Dr. Woodley said.

Gentamicin, an aminoglycoside, works as a “read-through therapy,” inducing ribosomal read-through of premature termination codons (PTCs) caused by nonsense mutations. The read-through allows translation to proceed and full-length proteins to be generated.

Gentamicin read-through therapy is also being investigated for recessive dystrophic epidermolysis bullosa (RDEB) attributable to nonsense mutations. The culprit mutations in this form of EB occur in a gene that encodes collagen type VII alpha 1, which, like laminin, is responsible for dermal-epidermal adherence. A clinical trial of intravenous gentamicin for RDEB is ongoing at USC, Dr. Chen said.


 

EBS-MD case report

It may also have a role in treating epidermolysis bullosa simplex with muscular dystrophy (EBS-MD), according to investigators in Madrid. Their case report, published in JAMA Dermatology, details how two 14-day courses of infused gentamicin therapy were followed by re-expression of plectin in the skin for 4-5 months and mild improvement in symptoms in one patient, a woman in her 30s, with a homozygous nonsense variant in PLEC1.

In an editorial accompanying the two reports, Anna L. Bruckner, MD, MSCS, professor of dermatology, University of Colorado at Denver, Aurora, and colleagues expressed cautious optimism and said that additional research on the feasibility, possible cumulative toxic effects, risk of microbial resistance, and overall clinical relevance is needed.

Still, the “investigators should be applauded for taking advantage of a readily available systemic treatment to target cutaneous and extracutaneous symptoms of patients who have very limited treatment options at this time,” they wrote. While all forms of EB are considered orphan disorders, JEB and EBS-MD have received less research attention than RDEB.

The JEB study evaluated patients with clinical assessments/quality of life surveys and with a validated clinical score that considers skin and mucosae – the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI). There were small positive changes in EBDASI scores, but data were incomplete and therefore difficult to interpret.

A “noteworthy” finding, the authors wrote, were improvements in emotions and functioning in two of the children who were eligible given their older ages for assessment with the Skindex-16 quality-of-life survey. The improvements suggest “potential psychosocial benefits” of the gentamicin therapy.

The JEB study was supported in part by grants from the EB Research Partnership and EB Medical Research Foundation and an award from the Congressionally Directed Medical Research Program. In addition to the grants, Dr. Woodley and Dr. Chen reported receiving personal fees from Phoenix Tissue Repair outside of the submitted work. For the EBS-MD case report, the authors reported no disclosures. Dr. Bruckner, corresponding author of the editorial, reported grants from several companies outside the submitted work.

Intravenous gentamicin therapy was associated with new laminin 332 – a major component of anchoring filaments in the dermal-epidermal junction – in the skin of five pediatric patients with intermediate or severe junctional epidermolysis bullosa (JEB) caused by nonsense variants.

The newly generated structural protein persisted during the 3-month randomized clinical trial and was associated with significant wound closure – with no signs of ototoxic effects, nephrotoxic effects, or anti–laminin 332 autoantibody induction, investigators recently reported in JAMA Dermatology.

JEB is a rare, autosomal recessive disorder caused mainly by nonsense variants (i.e., mutations) in the LAMA3, LAMB3, or LAMC2 genes that encode laminin, resulting in widespread blisters and erosions of the skin. Current treatment is limited to supportive management and palliative care, and children with its severe subtype are likely to die within the first year of life.

“With data indicating a robust response to short-term gentamicin treatment and the marked stability of laminin 332, we envision that gentamicin could be delivered as a short-term pulse therapy every 2-3 months for patients with JEB caused by nonsense variants,” the researchers wrote.

Of the five patients, ages 3 months to 10 years, three received 7.5 mg/kg IV gentamicin daily for 14 days, and two received 10 mg/kg daily for 24 days at the University of Southern California, Los Angeles.

All had confirmed nonsense variants in LAMA3 or LAMB3 in one or two alleles, and all had minimal laminin 332 expression at baseline as determined by immunofluorescence. After treatment, each of the children had increased, sustained expression of laminin 332.

The researchers monitored three open wounds in each patient. By 1 month, seven of nine wounds in those receiving the lower-dose therapy and all of the wounds in those receiving the higher-dose therapy showed at least 50% closure. By 3 months, eight of nine wounds in the lower-dose group, and all wounds in the higher-dose group showed greater than 85% closure.

In an interview, senior investigators Mei Chen, PhD, professor of dermatology, and David T. Woodley, MD, professor and chair of dermatology, both at USC, emphasized laminin’s long half-life.“Once these skin structural proteins are generated at the dermal-epidermal junction, they are long-lasting structures, which means the therapy can be pulsed rather than continuously delivered, which can obviate some of the known side effects of the medication,” Dr. Woodley said.

Gentamicin, an aminoglycoside, works as a “read-through therapy,” inducing ribosomal read-through of premature termination codons (PTCs) caused by nonsense mutations. The read-through allows translation to proceed and full-length proteins to be generated.

Gentamicin read-through therapy is also being investigated for recessive dystrophic epidermolysis bullosa (RDEB) attributable to nonsense mutations. The culprit mutations in this form of EB occur in a gene that encodes collagen type VII alpha 1, which, like laminin, is responsible for dermal-epidermal adherence. A clinical trial of intravenous gentamicin for RDEB is ongoing at USC, Dr. Chen said.


 

EBS-MD case report

It may also have a role in treating epidermolysis bullosa simplex with muscular dystrophy (EBS-MD), according to investigators in Madrid. Their case report, published in JAMA Dermatology, details how two 14-day courses of infused gentamicin therapy were followed by re-expression of plectin in the skin for 4-5 months and mild improvement in symptoms in one patient, a woman in her 30s, with a homozygous nonsense variant in PLEC1.

In an editorial accompanying the two reports, Anna L. Bruckner, MD, MSCS, professor of dermatology, University of Colorado at Denver, Aurora, and colleagues expressed cautious optimism and said that additional research on the feasibility, possible cumulative toxic effects, risk of microbial resistance, and overall clinical relevance is needed.

Still, the “investigators should be applauded for taking advantage of a readily available systemic treatment to target cutaneous and extracutaneous symptoms of patients who have very limited treatment options at this time,” they wrote. While all forms of EB are considered orphan disorders, JEB and EBS-MD have received less research attention than RDEB.

The JEB study evaluated patients with clinical assessments/quality of life surveys and with a validated clinical score that considers skin and mucosae – the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI). There were small positive changes in EBDASI scores, but data were incomplete and therefore difficult to interpret.

A “noteworthy” finding, the authors wrote, were improvements in emotions and functioning in two of the children who were eligible given their older ages for assessment with the Skindex-16 quality-of-life survey. The improvements suggest “potential psychosocial benefits” of the gentamicin therapy.

The JEB study was supported in part by grants from the EB Research Partnership and EB Medical Research Foundation and an award from the Congressionally Directed Medical Research Program. In addition to the grants, Dr. Woodley and Dr. Chen reported receiving personal fees from Phoenix Tissue Repair outside of the submitted work. For the EBS-MD case report, the authors reported no disclosures. Dr. Bruckner, corresponding author of the editorial, reported grants from several companies outside the submitted work.

Intravenous gentamicin therapy was associated with new laminin 332 – a major component of anchoring filaments in the dermal-epidermal junction – in the skin of five pediatric patients with intermediate or severe junctional epidermolysis bullosa (JEB) caused by nonsense variants.

The newly generated structural protein persisted during the 3-month randomized clinical trial and was associated with significant wound closure – with no signs of ototoxic effects, nephrotoxic effects, or anti–laminin 332 autoantibody induction, investigators recently reported in JAMA Dermatology.

JEB is a rare, autosomal recessive disorder caused mainly by nonsense variants (i.e., mutations) in the LAMA3, LAMB3, or LAMC2 genes that encode laminin, resulting in widespread blisters and erosions of the skin. Current treatment is limited to supportive management and palliative care, and children with its severe subtype are likely to die within the first year of life.

“With data indicating a robust response to short-term gentamicin treatment and the marked stability of laminin 332, we envision that gentamicin could be delivered as a short-term pulse therapy every 2-3 months for patients with JEB caused by nonsense variants,” the researchers wrote.

Of the five patients, ages 3 months to 10 years, three received 7.5 mg/kg IV gentamicin daily for 14 days, and two received 10 mg/kg daily for 24 days at the University of Southern California, Los Angeles.

All had confirmed nonsense variants in LAMA3 or LAMB3 in one or two alleles, and all had minimal laminin 332 expression at baseline as determined by immunofluorescence. After treatment, each of the children had increased, sustained expression of laminin 332.

The researchers monitored three open wounds in each patient. By 1 month, seven of nine wounds in those receiving the lower-dose therapy and all of the wounds in those receiving the higher-dose therapy showed at least 50% closure. By 3 months, eight of nine wounds in the lower-dose group, and all wounds in the higher-dose group showed greater than 85% closure.

In an interview, senior investigators Mei Chen, PhD, professor of dermatology, and David T. Woodley, MD, professor and chair of dermatology, both at USC, emphasized laminin’s long half-life.“Once these skin structural proteins are generated at the dermal-epidermal junction, they are long-lasting structures, which means the therapy can be pulsed rather than continuously delivered, which can obviate some of the known side effects of the medication,” Dr. Woodley said.

Gentamicin, an aminoglycoside, works as a “read-through therapy,” inducing ribosomal read-through of premature termination codons (PTCs) caused by nonsense mutations. The read-through allows translation to proceed and full-length proteins to be generated.

Gentamicin read-through therapy is also being investigated for recessive dystrophic epidermolysis bullosa (RDEB) attributable to nonsense mutations. The culprit mutations in this form of EB occur in a gene that encodes collagen type VII alpha 1, which, like laminin, is responsible for dermal-epidermal adherence. A clinical trial of intravenous gentamicin for RDEB is ongoing at USC, Dr. Chen said.


 

EBS-MD case report

It may also have a role in treating epidermolysis bullosa simplex with muscular dystrophy (EBS-MD), according to investigators in Madrid. Their case report, published in JAMA Dermatology, details how two 14-day courses of infused gentamicin therapy were followed by re-expression of plectin in the skin for 4-5 months and mild improvement in symptoms in one patient, a woman in her 30s, with a homozygous nonsense variant in PLEC1.

In an editorial accompanying the two reports, Anna L. Bruckner, MD, MSCS, professor of dermatology, University of Colorado at Denver, Aurora, and colleagues expressed cautious optimism and said that additional research on the feasibility, possible cumulative toxic effects, risk of microbial resistance, and overall clinical relevance is needed.

Still, the “investigators should be applauded for taking advantage of a readily available systemic treatment to target cutaneous and extracutaneous symptoms of patients who have very limited treatment options at this time,” they wrote. While all forms of EB are considered orphan disorders, JEB and EBS-MD have received less research attention than RDEB.

The JEB study evaluated patients with clinical assessments/quality of life surveys and with a validated clinical score that considers skin and mucosae – the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI). There were small positive changes in EBDASI scores, but data were incomplete and therefore difficult to interpret.

A “noteworthy” finding, the authors wrote, were improvements in emotions and functioning in two of the children who were eligible given their older ages for assessment with the Skindex-16 quality-of-life survey. The improvements suggest “potential psychosocial benefits” of the gentamicin therapy.

The JEB study was supported in part by grants from the EB Research Partnership and EB Medical Research Foundation and an award from the Congressionally Directed Medical Research Program. In addition to the grants, Dr. Woodley and Dr. Chen reported receiving personal fees from Phoenix Tissue Repair outside of the submitted work. For the EBS-MD case report, the authors reported no disclosures. Dr. Bruckner, corresponding author of the editorial, reported grants from several companies outside the submitted work.

A cross-sectional study in the United Kingdom has revealed an association between social media use and lower life satisfaction among children and adolescents aged 10-21 years.

“[Our] study provides evidence for age- and sex-specific windows of sensitivity to social media use in adolescence,” lead author Amy Orben, PhD, of the University of Cambridge (England), and colleagues wrote. The findings were published in Nature Communications.

The researchers analyzed cross-sectional and longitudinal data from the Understanding Society dataset and the Millennium Cohort Study. The cross-sectional data was used to investigate the existence of developmental windows of sensitivity to social media, while the longitudinal data was used to evaluate whether sex-specific windows of sensitivity to social media were present during the adolescence period.

These two datasets comprised 84,011 participants aged 10-80 years old. After applying the modeling framework, 17,409 participants aged 10-21 years were included in the analysis.

Longitudinal analyses revealed different developmental windows of sensitivity to social media during adolescence, with higher estimated social media use predicting lower life satisfaction scores 1 year later (regression coefficient [beta], −0.02; 95% confidence interval, −0.03 to −0.01; P = .004).

Among females, the researchers observed a window of sensitivity to social media between the ages of 11 and 13, with higher estimated social media use predicting lower life satisfaction ratings 1 year later (age 11: beta, −0.11; 95% CI, −0.21 to −0.02; P = .020; age 12: beta, −0.14; 95% CI, −0.22 to −0.07; P < .001; age 13: beta, −0.08; 95% CI, −0.15 to −0.01; P = .019).

Among males, a similar window was observed between the ages of 14 and 15 (age 14: beta, −0.10; 95% CI, −0.17 to −0.03; P = .005; age 15: beta, –0.18; 95% CI, −0.29 to −0.08; P = .001).

Furthermore, they showed that a later increase in sensitivity to social media, which was present at age 19 for both females and males, suggested a different underlying process was present in late adolescence (females: beta, −0.16; 95% CI, −0.25 to −0.07; P < .001; males: beta, −0.16; 95% CI, −0.26 to −0.07; P = .001).

“Speculatively, this might be related to changes in the social environment such as a move away from home and subsequent disruptions in social networks,” the researchers wrote.

Importantly, Dr. Orben and colleagues noted that these results should be interpreted with caution. Owing to the cross-sectional nature of the data, causality cannot be inferred from these findings.

“The findings reported here may enable investigation of potential mechanisms of interest, for example, in datasets with pubertal or additional social measurements,” they wrote. “One could also carry out more targeted investigations, for example, by examining the mental health measures only completed by select age ranges in the datasets.”
 

Digital literacy is important, expert says

“Digital literacy and education about social media use is warranted for all ages, starting young,” Yalda T. Uhls, MBA, PhD, of the department of psychology at the University of California, Los Angeles, said in an interview. “Attending to underlying issues for vulnerable ages, such as anxiety, as well as parental support is critical.”

“I would urge social media platforms to pay attention to what kinds of content they are making available to ensure the highest possible quality, and to embed things like suggestions for pauses and other ways to check in on someone who may be experiencing distress when on socials,” Dr. Uhls said. “We also need to increase access to mental health resources for young people and social media could help provide information for those experiencing issues.”

This study was supported by the University of Cambridge and the UK Medical Research Council. The authors reported no relevant disclosures. Dr. Uhls had no relevant disclosures.

A cross-sectional study in the United Kingdom has revealed an association between social media use and lower life satisfaction among children and adolescents aged 10-21 years.

“[Our] study provides evidence for age- and sex-specific windows of sensitivity to social media use in adolescence,” lead author Amy Orben, PhD, of the University of Cambridge (England), and colleagues wrote. The findings were published in Nature Communications.

The researchers analyzed cross-sectional and longitudinal data from the Understanding Society dataset and the Millennium Cohort Study. The cross-sectional data was used to investigate the existence of developmental windows of sensitivity to social media, while the longitudinal data was used to evaluate whether sex-specific windows of sensitivity to social media were present during the adolescence period.

These two datasets comprised 84,011 participants aged 10-80 years old. After applying the modeling framework, 17,409 participants aged 10-21 years were included in the analysis.

Longitudinal analyses revealed different developmental windows of sensitivity to social media during adolescence, with higher estimated social media use predicting lower life satisfaction scores 1 year later (regression coefficient [beta], −0.02; 95% confidence interval, −0.03 to −0.01; P = .004).

Among females, the researchers observed a window of sensitivity to social media between the ages of 11 and 13, with higher estimated social media use predicting lower life satisfaction ratings 1 year later (age 11: beta, −0.11; 95% CI, −0.21 to −0.02; P = .020; age 12: beta, −0.14; 95% CI, −0.22 to −0.07; P < .001; age 13: beta, −0.08; 95% CI, −0.15 to −0.01; P = .019).

Among males, a similar window was observed between the ages of 14 and 15 (age 14: beta, −0.10; 95% CI, −0.17 to −0.03; P = .005; age 15: beta, –0.18; 95% CI, −0.29 to −0.08; P = .001).

Furthermore, they showed that a later increase in sensitivity to social media, which was present at age 19 for both females and males, suggested a different underlying process was present in late adolescence (females: beta, −0.16; 95% CI, −0.25 to −0.07; P < .001; males: beta, −0.16; 95% CI, −0.26 to −0.07; P = .001).

“Speculatively, this might be related to changes in the social environment such as a move away from home and subsequent disruptions in social networks,” the researchers wrote.

Importantly, Dr. Orben and colleagues noted that these results should be interpreted with caution. Owing to the cross-sectional nature of the data, causality cannot be inferred from these findings.

“The findings reported here may enable investigation of potential mechanisms of interest, for example, in datasets with pubertal or additional social measurements,” they wrote. “One could also carry out more targeted investigations, for example, by examining the mental health measures only completed by select age ranges in the datasets.”
 

Digital literacy is important, expert says

“Digital literacy and education about social media use is warranted for all ages, starting young,” Yalda T. Uhls, MBA, PhD, of the department of psychology at the University of California, Los Angeles, said in an interview. “Attending to underlying issues for vulnerable ages, such as anxiety, as well as parental support is critical.”

“I would urge social media platforms to pay attention to what kinds of content they are making available to ensure the highest possible quality, and to embed things like suggestions for pauses and other ways to check in on someone who may be experiencing distress when on socials,” Dr. Uhls said. “We also need to increase access to mental health resources for young people and social media could help provide information for those experiencing issues.”

This study was supported by the University of Cambridge and the UK Medical Research Council. The authors reported no relevant disclosures. Dr. Uhls had no relevant disclosures.

A cross-sectional study in the United Kingdom has revealed an association between social media use and lower life satisfaction among children and adolescents aged 10-21 years.

“[Our] study provides evidence for age- and sex-specific windows of sensitivity to social media use in adolescence,” lead author Amy Orben, PhD, of the University of Cambridge (England), and colleagues wrote. The findings were published in Nature Communications.

The researchers analyzed cross-sectional and longitudinal data from the Understanding Society dataset and the Millennium Cohort Study. The cross-sectional data was used to investigate the existence of developmental windows of sensitivity to social media, while the longitudinal data was used to evaluate whether sex-specific windows of sensitivity to social media were present during the adolescence period.

These two datasets comprised 84,011 participants aged 10-80 years old. After applying the modeling framework, 17,409 participants aged 10-21 years were included in the analysis.

Longitudinal analyses revealed different developmental windows of sensitivity to social media during adolescence, with higher estimated social media use predicting lower life satisfaction scores 1 year later (regression coefficient [beta], −0.02; 95% confidence interval, −0.03 to −0.01; P = .004).

Among females, the researchers observed a window of sensitivity to social media between the ages of 11 and 13, with higher estimated social media use predicting lower life satisfaction ratings 1 year later (age 11: beta, −0.11; 95% CI, −0.21 to −0.02; P = .020; age 12: beta, −0.14; 95% CI, −0.22 to −0.07; P < .001; age 13: beta, −0.08; 95% CI, −0.15 to −0.01; P = .019).

Among males, a similar window was observed between the ages of 14 and 15 (age 14: beta, −0.10; 95% CI, −0.17 to −0.03; P = .005; age 15: beta, –0.18; 95% CI, −0.29 to −0.08; P = .001).

Furthermore, they showed that a later increase in sensitivity to social media, which was present at age 19 for both females and males, suggested a different underlying process was present in late adolescence (females: beta, −0.16; 95% CI, −0.25 to −0.07; P < .001; males: beta, −0.16; 95% CI, −0.26 to −0.07; P = .001).

“Speculatively, this might be related to changes in the social environment such as a move away from home and subsequent disruptions in social networks,” the researchers wrote.

Importantly, Dr. Orben and colleagues noted that these results should be interpreted with caution. Owing to the cross-sectional nature of the data, causality cannot be inferred from these findings.

“The findings reported here may enable investigation of potential mechanisms of interest, for example, in datasets with pubertal or additional social measurements,” they wrote. “One could also carry out more targeted investigations, for example, by examining the mental health measures only completed by select age ranges in the datasets.”
 

Digital literacy is important, expert says

“Digital literacy and education about social media use is warranted for all ages, starting young,” Yalda T. Uhls, MBA, PhD, of the department of psychology at the University of California, Los Angeles, said in an interview. “Attending to underlying issues for vulnerable ages, such as anxiety, as well as parental support is critical.”

“I would urge social media platforms to pay attention to what kinds of content they are making available to ensure the highest possible quality, and to embed things like suggestions for pauses and other ways to check in on someone who may be experiencing distress when on socials,” Dr. Uhls said. “We also need to increase access to mental health resources for young people and social media could help provide information for those experiencing issues.”

This study was supported by the University of Cambridge and the UK Medical Research Council. The authors reported no relevant disclosures. Dr. Uhls had no relevant disclosures.

There is a link between cannabis exposure during pregnancy and higher fasting glucose levels and adiposity in the offspring in early childhood, a new study suggests.

Research looking at the effect of prenatal exposure to cannabis on offspring is growing. It is known to affect childhood cognition and behavior; however, there is little work to date on how it affects metabolic outcomes, said lead author Brianna F. Moore, PhD.

“Officially, the American Academy of Obstetricians and Gynecologists recommends that women do not use cannabis during pregnancy or while breastfeeding to limit the effects on offspring. There’s really a lot we don’t know, but researchers across the country are starting to look into this more, and there are signs that it isn’t great for the offspring,” Dr. Moore, assistant professor at the Colorado School of Public Health in Aurora, said in an interview.

And she noted that while some women turn to cannabis to manage the challenging symptoms of pregnancy, “Clinicians should encourage pregnant women to refrain from using cannabis; it is best for these pregnant women to talk to their physicians about alternative ways of managing these symptoms.”

The findings were published online March 31 in the Journal of Clinical Endocrinology & Metabolism.
 

Study of mother and 5-year-old child pairs

The researchers assessed 103 sets of mothers and children from the Healthy Start study. At 27 weeks of gestation, the investigators assessed 12 metabolites of cannabis/cannabinoids in urine samples. Results from these samples were used to categorize fetal exposure to cannabis as either not exposed or exposed. They found that about 15% of the mothers had traceable amounts of cannabinoids, suggesting fetal cannabis exposure.

At follow-up, the study team assessed fat-free mass and fat mass using air displacement plethysmography among the offspring around age 5. They used generalized linear models to approximate the relationship between fetal exposure to cannabis with metabolic measures such as insulin, glucose, and homeostatic model assessment of insulin resistance (HOMA-IR), and adiposity measures such as body mass index, fat-free mass, fat mass, adiposity, and BMI z-scores.

The findings showed that, compared with nonexposed offspring, exposed offspring had greater:

• Fasting glucose (5.6 mg/dL; 95% confidence interval [CI], 0.8-10.3).
• Fat-free mass (1.2 kg; 95% CI, 0.4-2.0).
• Fat mass (1.0 kg; 95% CI, 0.3-1.7).
• Adiposity (2.6%; 95% CI, 0.1-5.2).

“This finding may suggest that fetal exposure to cannabis contributes to higher fasting glucose levels via a direct effect on the pancreatic β-cells. However, we cannot draw conclusions about β-cell response to glucose because we did not perform oral glucose tolerance tests,” the study authors wrote.

Notably, however, there was no relationship between BMI z-scores, BMI, or HOMA-IR and fasting insulin, the study team found.

Study limitations include the small sample size and lack of self-report data on cannabis use to differentiate between direct use and exposure to cannabis, Dr. Moore acknowledged.

Given the small sample size, the researchers were unable to look at dose-response, which future studies will focus on, Dr. Moore noted. Future efforts will also focus on comparing the effects of tetrahydrocannabinol (THC) and cannabidiol (CBD), Dr. Moore added.

“This is a relatively new field, so there’s still work to be done. This is just one study, and we need to study this more in other cohorts to confirm our findings,” she concluded.

Dr. Moore has reported no relevant financial relationships.

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

There is a link between cannabis exposure during pregnancy and higher fasting glucose levels and adiposity in the offspring in early childhood, a new study suggests.

Research looking at the effect of prenatal exposure to cannabis on offspring is growing. It is known to affect childhood cognition and behavior; however, there is little work to date on how it affects metabolic outcomes, said lead author Brianna F. Moore, PhD.

“Officially, the American Academy of Obstetricians and Gynecologists recommends that women do not use cannabis during pregnancy or while breastfeeding to limit the effects on offspring. There’s really a lot we don’t know, but researchers across the country are starting to look into this more, and there are signs that it isn’t great for the offspring,” Dr. Moore, assistant professor at the Colorado School of Public Health in Aurora, said in an interview.

And she noted that while some women turn to cannabis to manage the challenging symptoms of pregnancy, “Clinicians should encourage pregnant women to refrain from using cannabis; it is best for these pregnant women to talk to their physicians about alternative ways of managing these symptoms.”

The findings were published online March 31 in the Journal of Clinical Endocrinology & Metabolism.
 

Study of mother and 5-year-old child pairs

The researchers assessed 103 sets of mothers and children from the Healthy Start study. At 27 weeks of gestation, the investigators assessed 12 metabolites of cannabis/cannabinoids in urine samples. Results from these samples were used to categorize fetal exposure to cannabis as either not exposed or exposed. They found that about 15% of the mothers had traceable amounts of cannabinoids, suggesting fetal cannabis exposure.

At follow-up, the study team assessed fat-free mass and fat mass using air displacement plethysmography among the offspring around age 5. They used generalized linear models to approximate the relationship between fetal exposure to cannabis with metabolic measures such as insulin, glucose, and homeostatic model assessment of insulin resistance (HOMA-IR), and adiposity measures such as body mass index, fat-free mass, fat mass, adiposity, and BMI z-scores.

The findings showed that, compared with nonexposed offspring, exposed offspring had greater:

• Fasting glucose (5.6 mg/dL; 95% confidence interval [CI], 0.8-10.3).
• Fat-free mass (1.2 kg; 95% CI, 0.4-2.0).
• Fat mass (1.0 kg; 95% CI, 0.3-1.7).
• Adiposity (2.6%; 95% CI, 0.1-5.2).

“This finding may suggest that fetal exposure to cannabis contributes to higher fasting glucose levels via a direct effect on the pancreatic β-cells. However, we cannot draw conclusions about β-cell response to glucose because we did not perform oral glucose tolerance tests,” the study authors wrote.

Notably, however, there was no relationship between BMI z-scores, BMI, or HOMA-IR and fasting insulin, the study team found.

Study limitations include the small sample size and lack of self-report data on cannabis use to differentiate between direct use and exposure to cannabis, Dr. Moore acknowledged.

Given the small sample size, the researchers were unable to look at dose-response, which future studies will focus on, Dr. Moore noted. Future efforts will also focus on comparing the effects of tetrahydrocannabinol (THC) and cannabidiol (CBD), Dr. Moore added.

“This is a relatively new field, so there’s still work to be done. This is just one study, and we need to study this more in other cohorts to confirm our findings,” she concluded.

Dr. Moore has reported no relevant financial relationships.

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

There is a link between cannabis exposure during pregnancy and higher fasting glucose levels and adiposity in the offspring in early childhood, a new study suggests.

Research looking at the effect of prenatal exposure to cannabis on offspring is growing. It is known to affect childhood cognition and behavior; however, there is little work to date on how it affects metabolic outcomes, said lead author Brianna F. Moore, PhD.

“Officially, the American Academy of Obstetricians and Gynecologists recommends that women do not use cannabis during pregnancy or while breastfeeding to limit the effects on offspring. There’s really a lot we don’t know, but researchers across the country are starting to look into this more, and there are signs that it isn’t great for the offspring,” Dr. Moore, assistant professor at the Colorado School of Public Health in Aurora, said in an interview.

And she noted that while some women turn to cannabis to manage the challenging symptoms of pregnancy, “Clinicians should encourage pregnant women to refrain from using cannabis; it is best for these pregnant women to talk to their physicians about alternative ways of managing these symptoms.”

The findings were published online March 31 in the Journal of Clinical Endocrinology & Metabolism.
 

Study of mother and 5-year-old child pairs

The researchers assessed 103 sets of mothers and children from the Healthy Start study. At 27 weeks of gestation, the investigators assessed 12 metabolites of cannabis/cannabinoids in urine samples. Results from these samples were used to categorize fetal exposure to cannabis as either not exposed or exposed. They found that about 15% of the mothers had traceable amounts of cannabinoids, suggesting fetal cannabis exposure.

At follow-up, the study team assessed fat-free mass and fat mass using air displacement plethysmography among the offspring around age 5. They used generalized linear models to approximate the relationship between fetal exposure to cannabis with metabolic measures such as insulin, glucose, and homeostatic model assessment of insulin resistance (HOMA-IR), and adiposity measures such as body mass index, fat-free mass, fat mass, adiposity, and BMI z-scores.

The findings showed that, compared with nonexposed offspring, exposed offspring had greater:

• Fasting glucose (5.6 mg/dL; 95% confidence interval [CI], 0.8-10.3).
• Fat-free mass (1.2 kg; 95% CI, 0.4-2.0).
• Fat mass (1.0 kg; 95% CI, 0.3-1.7).
• Adiposity (2.6%; 95% CI, 0.1-5.2).

“This finding may suggest that fetal exposure to cannabis contributes to higher fasting glucose levels via a direct effect on the pancreatic β-cells. However, we cannot draw conclusions about β-cell response to glucose because we did not perform oral glucose tolerance tests,” the study authors wrote.

Notably, however, there was no relationship between BMI z-scores, BMI, or HOMA-IR and fasting insulin, the study team found.

Study limitations include the small sample size and lack of self-report data on cannabis use to differentiate between direct use and exposure to cannabis, Dr. Moore acknowledged.

Given the small sample size, the researchers were unable to look at dose-response, which future studies will focus on, Dr. Moore noted. Future efforts will also focus on comparing the effects of tetrahydrocannabinol (THC) and cannabidiol (CBD), Dr. Moore added.

“This is a relatively new field, so there’s still work to be done. This is just one study, and we need to study this more in other cohorts to confirm our findings,” she concluded.

Dr. Moore has reported no relevant financial relationships.

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

As they rolled me down the hallway to the OR, ceiling lights rhythmically passing above, I zoned out into a 1,000-mile stare. How did I get here? I started humming “Swing Low, Sweet Chariot,” praying for a miracle to happen. I thought back to my birth plan, meticulously crafted, a one-pager so that the no-nonsense labor and delivery nurses wouldn›t think me completely off my rocker. No C-section unless medically necessary. Those words laughed back at me – cackling, even. I’d planned out the whole birthing process and here we were, my team almost jogging me to the OR. I lay still, utterly gobsmacked and partially anesthetized.

If I squint my eyes and hallucinate just a bit, that is sort of what motherhood has been like.

It’s about knowing all the things that could go wrong and meeting the unplanned head-on. Motherhood has indeed been a whirlwind – so many physical, psychological, and emotional transformations. And to top it off, the added effort of giving birth in a pandemic. As an over-40 physician, you’d think I would have been better prepared.

I was, but in a sense, I was not. The knowledge, the wisdom, the experience of my medical training surrounded me, but even I panicked at times in the beginning: Am I feeding her correctly? Am I making enough food for her? Am I doing the best that I can for her? What more could I be doing for her?

Over time, I’ve learned to lighten up. Some. In those teachable moments with my daughter Gia, I’ve learned to not sugarcoat reality but encourage the hopeful. If Gia falls on the ground? “You’re okay, sweetie. Now get back up.” If Gia has a tantrum and starts hitting herself? “Honey, our hands are for hugs, not hurting ourselves. Let’s go play.” Eighty percent of motherhood right now is redirection and the other 20% is patience.

I remember this one time I was rushing out the door for work. After getting in the car with my keys, I realized I forgot my coffee back in the house. I left the car, went back in the house to grab the blessed joe, went back to the car, and couldn’t get in because it was locked. I panicked at that moment, went back inside the house, and found Gia playing with my extra key fob. My own daughter locked me out of my car. Of course, it wasn’t her fault. Deep breath and I offered her another kiss while simultaneously taking the key fob from her.

Before Gia could walk, she could climb the stairs in our home. Her father and I sometimes refer to her as “Lil Bamm-Bamm” because she is so strong. One day, Daddy was supposed to be watching her while Mommy was folding laundry upstairs. She was not allowed on the stairs, but what should I hear? Literally, the pitter-patter of little feet, running down the upstairs hallway. Her father had drifted off watching yet another episode of something Star Wars–related. My strong little girl made it up the stairs all by herself and Dad received a strong word. The Force was with me that day.

I would say that I feel like having a child ages you, but what does that really mean when you’re already old? I’ve become acutely aware of my lack of endurance, stamina, and bodily strength. My knees will creak when taking her upstairs to bed, an osseous dirge of a lullaby. Date nights become unintentionally less and less frequent. Friday night dress-up becomes Friday night dress-down. I’ve replaced stiletto heels with comfy sweats.

Once we put Gia down for the night, we are usually exhausted from the day, and the couch and TV are welcome respites. We exhale. As over-40 parents, we knew that having children late in life would bring its challenges. But I’d like to think that we are meeting them the best way that we can. Often I encourage my body to meet Gia at her eye level, see what she sees, play with her on her own terms, and match her energy. She absolutely loves it when I do this. I’m out of breath and my knees are sore by the end of our play session, but I wouldn’t have it any other way.

We are learning from each other. She has a bright and assertive personality, and I am protective of that innocence. Her innocence is without fear. I often wonder what she is thinking when I see her facial expressions. A side-eye, a fleeting giggle. Is she secretly contemplating the chronicity of the cosmos, or is it just gas? I look at her in stolen moments and still can’t believe that I grew a human inside me, and said human was extracted from me and is now walking around my house commanding her bidding. So surreal. The unromanticized, scientific ingredients that are at play from conception to delivery are nothing short of miraculous. And the miracles of parenting over 40 are present every day.

Dr. Tolliver is a family medicine physician at The Ohio State University Wexner Medical Center in Columbus. A version of this article first appeared on Medscape.com.

As they rolled me down the hallway to the OR, ceiling lights rhythmically passing above, I zoned out into a 1,000-mile stare. How did I get here? I started humming “Swing Low, Sweet Chariot,” praying for a miracle to happen. I thought back to my birth plan, meticulously crafted, a one-pager so that the no-nonsense labor and delivery nurses wouldn›t think me completely off my rocker. No C-section unless medically necessary. Those words laughed back at me – cackling, even. I’d planned out the whole birthing process and here we were, my team almost jogging me to the OR. I lay still, utterly gobsmacked and partially anesthetized.

If I squint my eyes and hallucinate just a bit, that is sort of what motherhood has been like.

It’s about knowing all the things that could go wrong and meeting the unplanned head-on. Motherhood has indeed been a whirlwind – so many physical, psychological, and emotional transformations. And to top it off, the added effort of giving birth in a pandemic. As an over-40 physician, you’d think I would have been better prepared.

I was, but in a sense, I was not. The knowledge, the wisdom, the experience of my medical training surrounded me, but even I panicked at times in the beginning: Am I feeding her correctly? Am I making enough food for her? Am I doing the best that I can for her? What more could I be doing for her?

Over time, I’ve learned to lighten up. Some. In those teachable moments with my daughter Gia, I’ve learned to not sugarcoat reality but encourage the hopeful. If Gia falls on the ground? “You’re okay, sweetie. Now get back up.” If Gia has a tantrum and starts hitting herself? “Honey, our hands are for hugs, not hurting ourselves. Let’s go play.” Eighty percent of motherhood right now is redirection and the other 20% is patience.

I remember this one time I was rushing out the door for work. After getting in the car with my keys, I realized I forgot my coffee back in the house. I left the car, went back in the house to grab the blessed joe, went back to the car, and couldn’t get in because it was locked. I panicked at that moment, went back inside the house, and found Gia playing with my extra key fob. My own daughter locked me out of my car. Of course, it wasn’t her fault. Deep breath and I offered her another kiss while simultaneously taking the key fob from her.

Before Gia could walk, she could climb the stairs in our home. Her father and I sometimes refer to her as “Lil Bamm-Bamm” because she is so strong. One day, Daddy was supposed to be watching her while Mommy was folding laundry upstairs. She was not allowed on the stairs, but what should I hear? Literally, the pitter-patter of little feet, running down the upstairs hallway. Her father had drifted off watching yet another episode of something Star Wars–related. My strong little girl made it up the stairs all by herself and Dad received a strong word. The Force was with me that day.

I would say that I feel like having a child ages you, but what does that really mean when you’re already old? I’ve become acutely aware of my lack of endurance, stamina, and bodily strength. My knees will creak when taking her upstairs to bed, an osseous dirge of a lullaby. Date nights become unintentionally less and less frequent. Friday night dress-up becomes Friday night dress-down. I’ve replaced stiletto heels with comfy sweats.

Once we put Gia down for the night, we are usually exhausted from the day, and the couch and TV are welcome respites. We exhale. As over-40 parents, we knew that having children late in life would bring its challenges. But I’d like to think that we are meeting them the best way that we can. Often I encourage my body to meet Gia at her eye level, see what she sees, play with her on her own terms, and match her energy. She absolutely loves it when I do this. I’m out of breath and my knees are sore by the end of our play session, but I wouldn’t have it any other way.

We are learning from each other. She has a bright and assertive personality, and I am protective of that innocence. Her innocence is without fear. I often wonder what she is thinking when I see her facial expressions. A side-eye, a fleeting giggle. Is she secretly contemplating the chronicity of the cosmos, or is it just gas? I look at her in stolen moments and still can’t believe that I grew a human inside me, and said human was extracted from me and is now walking around my house commanding her bidding. So surreal. The unromanticized, scientific ingredients that are at play from conception to delivery are nothing short of miraculous. And the miracles of parenting over 40 are present every day.

Dr. Tolliver is a family medicine physician at The Ohio State University Wexner Medical Center in Columbus. A version of this article first appeared on Medscape.com.

As they rolled me down the hallway to the OR, ceiling lights rhythmically passing above, I zoned out into a 1,000-mile stare. How did I get here? I started humming “Swing Low, Sweet Chariot,” praying for a miracle to happen. I thought back to my birth plan, meticulously crafted, a one-pager so that the no-nonsense labor and delivery nurses wouldn›t think me completely off my rocker. No C-section unless medically necessary. Those words laughed back at me – cackling, even. I’d planned out the whole birthing process and here we were, my team almost jogging me to the OR. I lay still, utterly gobsmacked and partially anesthetized.

If I squint my eyes and hallucinate just a bit, that is sort of what motherhood has been like.

It’s about knowing all the things that could go wrong and meeting the unplanned head-on. Motherhood has indeed been a whirlwind – so many physical, psychological, and emotional transformations. And to top it off, the added effort of giving birth in a pandemic. As an over-40 physician, you’d think I would have been better prepared.

I was, but in a sense, I was not. The knowledge, the wisdom, the experience of my medical training surrounded me, but even I panicked at times in the beginning: Am I feeding her correctly? Am I making enough food for her? Am I doing the best that I can for her? What more could I be doing for her?

Over time, I’ve learned to lighten up. Some. In those teachable moments with my daughter Gia, I’ve learned to not sugarcoat reality but encourage the hopeful. If Gia falls on the ground? “You’re okay, sweetie. Now get back up.” If Gia has a tantrum and starts hitting herself? “Honey, our hands are for hugs, not hurting ourselves. Let’s go play.” Eighty percent of motherhood right now is redirection and the other 20% is patience.

I remember this one time I was rushing out the door for work. After getting in the car with my keys, I realized I forgot my coffee back in the house. I left the car, went back in the house to grab the blessed joe, went back to the car, and couldn’t get in because it was locked. I panicked at that moment, went back inside the house, and found Gia playing with my extra key fob. My own daughter locked me out of my car. Of course, it wasn’t her fault. Deep breath and I offered her another kiss while simultaneously taking the key fob from her.

Before Gia could walk, she could climb the stairs in our home. Her father and I sometimes refer to her as “Lil Bamm-Bamm” because she is so strong. One day, Daddy was supposed to be watching her while Mommy was folding laundry upstairs. She was not allowed on the stairs, but what should I hear? Literally, the pitter-patter of little feet, running down the upstairs hallway. Her father had drifted off watching yet another episode of something Star Wars–related. My strong little girl made it up the stairs all by herself and Dad received a strong word. The Force was with me that day.

I would say that I feel like having a child ages you, but what does that really mean when you’re already old? I’ve become acutely aware of my lack of endurance, stamina, and bodily strength. My knees will creak when taking her upstairs to bed, an osseous dirge of a lullaby. Date nights become unintentionally less and less frequent. Friday night dress-up becomes Friday night dress-down. I’ve replaced stiletto heels with comfy sweats.

Once we put Gia down for the night, we are usually exhausted from the day, and the couch and TV are welcome respites. We exhale. As over-40 parents, we knew that having children late in life would bring its challenges. But I’d like to think that we are meeting them the best way that we can. Often I encourage my body to meet Gia at her eye level, see what she sees, play with her on her own terms, and match her energy. She absolutely loves it when I do this. I’m out of breath and my knees are sore by the end of our play session, but I wouldn’t have it any other way.

We are learning from each other. She has a bright and assertive personality, and I am protective of that innocence. Her innocence is without fear. I often wonder what she is thinking when I see her facial expressions. A side-eye, a fleeting giggle. Is she secretly contemplating the chronicity of the cosmos, or is it just gas? I look at her in stolen moments and still can’t believe that I grew a human inside me, and said human was extracted from me and is now walking around my house commanding her bidding. So surreal. The unromanticized, scientific ingredients that are at play from conception to delivery are nothing short of miraculous. And the miracles of parenting over 40 are present every day.

Dr. Tolliver is a family medicine physician at The Ohio State University Wexner Medical Center in Columbus. A version of this article first appeared on Medscape.com.

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.

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.

When polio paralyzed a 3-year-old girl in Lilongwe, Malawi, in November 2021, public health experts in Malawi’s Ministry of Health responded quickly. The ministry partnered with the Global Polio Eradication Initiative, the World Health Organization, and the United Nations International Children’s Emergency Fund to mobilize a surge team of personnel and resources to vaccinate all 2.9 million Malawian children aged under 5 years, WHO reported in a news release.

The first of four sequential campaigns began on March 20 and expanded on March 24 to neighboring Mozambique, Tanzania, and Zambia. The multinational, multiagency effort aims to include Zimbabwean children as well and deliver over 80 million supplemental doses of bivalent oral polio vaccines to over 23 million children in these five countries by July.

Because it takes multiple polio vaccine doses to become fully immunized, the children are expected to receive four rounds of vaccine regardless of their vaccination history.

“It is important to conduct the campaigns now to boost the immunity of our children,” Annie Chauma-Mwale, MBBS, MPH, the chief medical officer of epidemiology and surveillance in Malawi’s Ministry of Health in Lilongwe, said in an interview. “Polio is not only a medical issue. Polio is also a socioeconomic issue with long-term impacts on the child, the country, and the globe.

“In Malawi, we are using our community health and health care facility structures to ensure we do not miss any eligible child,” explained Dr. Chauma-Mwale, who is also the deputy incident manager of the poliovirus outbreak response. “We aim to play our role in the global eradication of polio by protecting the vulnerable and curtailing any potential transmission as early as possible.”

Of the three variants of wild, naturally occurring poliovirus, types 2 and 3 have been eradicated, but wild poliovirus type 1 (WPV1) remains endemic in Afghanistan and Pakistan.

As reported recently by this news organization, the girl in Malawi was infected with a WPV1 strain that had been circulating for years in Pakistan’s Sindh Province.

Malawi’s most recent clinically confirmed WPV1 case was reported in 1992, and this is the first WPV1 case detected in Africa since 2016. The continent was declared free of indigenous wild polio in 2020 and is still considered free of wild poliovirus because the child’s illness was imported from elsewhere.

The 3-year-old girl developed acute flaccid paralysis in November 2021. In February 2022, virus from her stool was sequenced by the National Institute of Communicable Disease in South Africa and the U.S. Centers for Disease Control and Prevention. On Feb. 16, Malawi was notified of the case, which was genetically linked to a sequence detected in Sindh Province around 2 years earlier.
 

‘Do not ignore polio’

Within 24 hours, the Government of Malawi declared a public health emergency and activated the national Emergency Operations Centre. Within 72 hours, the GPEI rapid response team arrived in the country. The Ministry of Health partnered with GPEI, WHO, and UNICEF to mobilize the campaign and begin vaccinating children on March 20.

‘’We rely on clinicians to support the surveillance of polio through case searches, both active and passive,” Mike Nenani Chisema, MBBS, MPH, the program manager of the expanded program on immunization and the polio response operations manager in Malawi’s Ministry of Health, said in an interview.

He noted that the young girl was diagnosed correctly and millions of children are now being protected against the disease, thanks to the acumen of one hospital clinician.

“Remember, we still have polio in some countries, and every country is at risk,” he cautioned. “Don’t forget to look for the obvious and do not ignore polio, regardless of economic status.’’

According to GPEI, all countries – especially those with weak immunization and other public health programs whose residents trade or travel to and from endemic countries – are at risk for imported polio.

Anita Gupta, DO, MPP, PharmD, an adjunct assistant professor of anesthesiology and critical care medicine and pain medicine at the Johns Hopkins University, Baltimore, said that she welcomes this effort.

“Given the decades of published evidence and understanding on the vaccine’s safety and efficacy, this program in Malawi is the right step to take,” Gupta, who is not involved in the campaigns, said in an interview. “Polio is preventable, and acting now will prevent spread later.”

Dr. Chauma-Mwale and Dr. Chisema are employees of Malawi’s Ministry of Health. Dr. Gupta disclosed no relevant financial relationships.

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

When polio paralyzed a 3-year-old girl in Lilongwe, Malawi, in November 2021, public health experts in Malawi’s Ministry of Health responded quickly. The ministry partnered with the Global Polio Eradication Initiative, the World Health Organization, and the United Nations International Children’s Emergency Fund to mobilize a surge team of personnel and resources to vaccinate all 2.9 million Malawian children aged under 5 years, WHO reported in a news release.

The first of four sequential campaigns began on March 20 and expanded on March 24 to neighboring Mozambique, Tanzania, and Zambia. The multinational, multiagency effort aims to include Zimbabwean children as well and deliver over 80 million supplemental doses of bivalent oral polio vaccines to over 23 million children in these five countries by July.

Because it takes multiple polio vaccine doses to become fully immunized, the children are expected to receive four rounds of vaccine regardless of their vaccination history.

“It is important to conduct the campaigns now to boost the immunity of our children,” Annie Chauma-Mwale, MBBS, MPH, the chief medical officer of epidemiology and surveillance in Malawi’s Ministry of Health in Lilongwe, said in an interview. “Polio is not only a medical issue. Polio is also a socioeconomic issue with long-term impacts on the child, the country, and the globe.

“In Malawi, we are using our community health and health care facility structures to ensure we do not miss any eligible child,” explained Dr. Chauma-Mwale, who is also the deputy incident manager of the poliovirus outbreak response. “We aim to play our role in the global eradication of polio by protecting the vulnerable and curtailing any potential transmission as early as possible.”

Of the three variants of wild, naturally occurring poliovirus, types 2 and 3 have been eradicated, but wild poliovirus type 1 (WPV1) remains endemic in Afghanistan and Pakistan.

As reported recently by this news organization, the girl in Malawi was infected with a WPV1 strain that had been circulating for years in Pakistan’s Sindh Province.

Malawi’s most recent clinically confirmed WPV1 case was reported in 1992, and this is the first WPV1 case detected in Africa since 2016. The continent was declared free of indigenous wild polio in 2020 and is still considered free of wild poliovirus because the child’s illness was imported from elsewhere.

The 3-year-old girl developed acute flaccid paralysis in November 2021. In February 2022, virus from her stool was sequenced by the National Institute of Communicable Disease in South Africa and the U.S. Centers for Disease Control and Prevention. On Feb. 16, Malawi was notified of the case, which was genetically linked to a sequence detected in Sindh Province around 2 years earlier.
 

‘Do not ignore polio’

Within 24 hours, the Government of Malawi declared a public health emergency and activated the national Emergency Operations Centre. Within 72 hours, the GPEI rapid response team arrived in the country. The Ministry of Health partnered with GPEI, WHO, and UNICEF to mobilize the campaign and begin vaccinating children on March 20.

‘’We rely on clinicians to support the surveillance of polio through case searches, both active and passive,” Mike Nenani Chisema, MBBS, MPH, the program manager of the expanded program on immunization and the polio response operations manager in Malawi’s Ministry of Health, said in an interview.

He noted that the young girl was diagnosed correctly and millions of children are now being protected against the disease, thanks to the acumen of one hospital clinician.

“Remember, we still have polio in some countries, and every country is at risk,” he cautioned. “Don’t forget to look for the obvious and do not ignore polio, regardless of economic status.’’

According to GPEI, all countries – especially those with weak immunization and other public health programs whose residents trade or travel to and from endemic countries – are at risk for imported polio.

Anita Gupta, DO, MPP, PharmD, an adjunct assistant professor of anesthesiology and critical care medicine and pain medicine at the Johns Hopkins University, Baltimore, said that she welcomes this effort.

“Given the decades of published evidence and understanding on the vaccine’s safety and efficacy, this program in Malawi is the right step to take,” Gupta, who is not involved in the campaigns, said in an interview. “Polio is preventable, and acting now will prevent spread later.”

Dr. Chauma-Mwale and Dr. Chisema are employees of Malawi’s Ministry of Health. Dr. Gupta disclosed no relevant financial relationships.

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

When polio paralyzed a 3-year-old girl in Lilongwe, Malawi, in November 2021, public health experts in Malawi’s Ministry of Health responded quickly. The ministry partnered with the Global Polio Eradication Initiative, the World Health Organization, and the United Nations International Children’s Emergency Fund to mobilize a surge team of personnel and resources to vaccinate all 2.9 million Malawian children aged under 5 years, WHO reported in a news release.

The first of four sequential campaigns began on March 20 and expanded on March 24 to neighboring Mozambique, Tanzania, and Zambia. The multinational, multiagency effort aims to include Zimbabwean children as well and deliver over 80 million supplemental doses of bivalent oral polio vaccines to over 23 million children in these five countries by July.

Because it takes multiple polio vaccine doses to become fully immunized, the children are expected to receive four rounds of vaccine regardless of their vaccination history.

“It is important to conduct the campaigns now to boost the immunity of our children,” Annie Chauma-Mwale, MBBS, MPH, the chief medical officer of epidemiology and surveillance in Malawi’s Ministry of Health in Lilongwe, said in an interview. “Polio is not only a medical issue. Polio is also a socioeconomic issue with long-term impacts on the child, the country, and the globe.

“In Malawi, we are using our community health and health care facility structures to ensure we do not miss any eligible child,” explained Dr. Chauma-Mwale, who is also the deputy incident manager of the poliovirus outbreak response. “We aim to play our role in the global eradication of polio by protecting the vulnerable and curtailing any potential transmission as early as possible.”

Of the three variants of wild, naturally occurring poliovirus, types 2 and 3 have been eradicated, but wild poliovirus type 1 (WPV1) remains endemic in Afghanistan and Pakistan.

As reported recently by this news organization, the girl in Malawi was infected with a WPV1 strain that had been circulating for years in Pakistan’s Sindh Province.

Malawi’s most recent clinically confirmed WPV1 case was reported in 1992, and this is the first WPV1 case detected in Africa since 2016. The continent was declared free of indigenous wild polio in 2020 and is still considered free of wild poliovirus because the child’s illness was imported from elsewhere.

The 3-year-old girl developed acute flaccid paralysis in November 2021. In February 2022, virus from her stool was sequenced by the National Institute of Communicable Disease in South Africa and the U.S. Centers for Disease Control and Prevention. On Feb. 16, Malawi was notified of the case, which was genetically linked to a sequence detected in Sindh Province around 2 years earlier.
 

‘Do not ignore polio’

Within 24 hours, the Government of Malawi declared a public health emergency and activated the national Emergency Operations Centre. Within 72 hours, the GPEI rapid response team arrived in the country. The Ministry of Health partnered with GPEI, WHO, and UNICEF to mobilize the campaign and begin vaccinating children on March 20.

‘’We rely on clinicians to support the surveillance of polio through case searches, both active and passive,” Mike Nenani Chisema, MBBS, MPH, the program manager of the expanded program on immunization and the polio response operations manager in Malawi’s Ministry of Health, said in an interview.

He noted that the young girl was diagnosed correctly and millions of children are now being protected against the disease, thanks to the acumen of one hospital clinician.

“Remember, we still have polio in some countries, and every country is at risk,” he cautioned. “Don’t forget to look for the obvious and do not ignore polio, regardless of economic status.’’

According to GPEI, all countries – especially those with weak immunization and other public health programs whose residents trade or travel to and from endemic countries – are at risk for imported polio.

Anita Gupta, DO, MPP, PharmD, an adjunct assistant professor of anesthesiology and critical care medicine and pain medicine at the Johns Hopkins University, Baltimore, said that she welcomes this effort.

“Given the decades of published evidence and understanding on the vaccine’s safety and efficacy, this program in Malawi is the right step to take,” Gupta, who is not involved in the campaigns, said in an interview. “Polio is preventable, and acting now will prevent spread later.”

Dr. Chauma-Mwale and Dr. Chisema are employees of Malawi’s Ministry of Health. Dr. Gupta disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.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.

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.

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.

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.