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Oscillatory ventilation reduced reintubation risk for preterm infants
Nasal high-frequency oscillatory ventilation, in a randomized trial of 206 preterm infants with respiratory failure.
Previous studies have supported the use of NHFOV as more effective for reducing CO2 and for lowering the risk of reintubation compared with NCPAP. But no randomized, controlled trials had compared the outcomes for preterm infants in particular, wrote Long Chen, MD, PhD, of Children’s Hospital of Chongqing Medical University, Chongqing, China, and colleagues.
Their study, published in Chest, was conducted at a single tertiary NICU in China between May 2017 and May 2018, and randomized infants with a gestational age less than 37 weeks to NHFOV (103 infants) or NCPAP (103 infants). Infants with major congenital abnormalities were excluded. The infants included 127 (61.7%) diagnosed with respiratory distress syndrome (RDS), 53 (25.7%) diagnosed with acute RDS (ARDS), and 26 (12.6%) diagnosed with both RDS and ARDS.
Overall, the reintubation rate within 6 hours was significantly lower among infants treated with NHFOV compared with those treated with NCPAP (15.5% vs. 34%, P = .002), and in the subset of infants with ARDS (23.5% vs. 52.6%, P = .032). Among infants with a gestational age of 32 weeks or less, reintuibation rates were also significantly lower among those treated with NHFOV (26.1% vs. 55.6%, P = .004).
In addition, PCO2 levels, 6 hours after extubation, were significantly lower among infants on NHFOV, compared with those on NCPAP (49.6 vs. 56.9 P = .00). The hospital stay, a secondary outcome, was significantly shorter among the infants treated with NHFOV, than those treated with NCPAP (22 days, vs. 27.6 days, P =.011).
Although the researchers observed some nasal trauma in NHFOV-treated patients, and intestinal dilation in both groups similar to side effects seen in previous studies, no feeding intolerance or skin lesions were associated with NHFOV. The study findings were consistent with those from previous studies, and suggested that the causes of respiratory failure might account for the differences between the treatment groups, they noted.
“RDS is primarily restrictive in the acute phase, and the high frequency oscillation over CPAP does not therefore bring any benefit. However, ARDS is both restrictive and obstructive in the acute phase due to the nature of ARDS,” and NHFOV is “able to improve oxygenation,” they added.
The study findings were limited by several factors including the use of data from a single center and the small number of infants younger than 28 weeks’ gestation, the researchers noted. However, they added, two international, multicenter, randomized controlled trials are in the works.
The study was supported by Social Livelihood Program of 38 Chongqing Science and Technology Commission, China. The researchers had no financial conflicts to disclose.
SOURCE: Long C et al. Chest. 2019; 155(4): 740-8.
Nasal high-frequency oscillatory ventilation, in a randomized trial of 206 preterm infants with respiratory failure.
Previous studies have supported the use of NHFOV as more effective for reducing CO2 and for lowering the risk of reintubation compared with NCPAP. But no randomized, controlled trials had compared the outcomes for preterm infants in particular, wrote Long Chen, MD, PhD, of Children’s Hospital of Chongqing Medical University, Chongqing, China, and colleagues.
Their study, published in Chest, was conducted at a single tertiary NICU in China between May 2017 and May 2018, and randomized infants with a gestational age less than 37 weeks to NHFOV (103 infants) or NCPAP (103 infants). Infants with major congenital abnormalities were excluded. The infants included 127 (61.7%) diagnosed with respiratory distress syndrome (RDS), 53 (25.7%) diagnosed with acute RDS (ARDS), and 26 (12.6%) diagnosed with both RDS and ARDS.
Overall, the reintubation rate within 6 hours was significantly lower among infants treated with NHFOV compared with those treated with NCPAP (15.5% vs. 34%, P = .002), and in the subset of infants with ARDS (23.5% vs. 52.6%, P = .032). Among infants with a gestational age of 32 weeks or less, reintuibation rates were also significantly lower among those treated with NHFOV (26.1% vs. 55.6%, P = .004).
In addition, PCO2 levels, 6 hours after extubation, were significantly lower among infants on NHFOV, compared with those on NCPAP (49.6 vs. 56.9 P = .00). The hospital stay, a secondary outcome, was significantly shorter among the infants treated with NHFOV, than those treated with NCPAP (22 days, vs. 27.6 days, P =.011).
Although the researchers observed some nasal trauma in NHFOV-treated patients, and intestinal dilation in both groups similar to side effects seen in previous studies, no feeding intolerance or skin lesions were associated with NHFOV. The study findings were consistent with those from previous studies, and suggested that the causes of respiratory failure might account for the differences between the treatment groups, they noted.
“RDS is primarily restrictive in the acute phase, and the high frequency oscillation over CPAP does not therefore bring any benefit. However, ARDS is both restrictive and obstructive in the acute phase due to the nature of ARDS,” and NHFOV is “able to improve oxygenation,” they added.
The study findings were limited by several factors including the use of data from a single center and the small number of infants younger than 28 weeks’ gestation, the researchers noted. However, they added, two international, multicenter, randomized controlled trials are in the works.
The study was supported by Social Livelihood Program of 38 Chongqing Science and Technology Commission, China. The researchers had no financial conflicts to disclose.
SOURCE: Long C et al. Chest. 2019; 155(4): 740-8.
Nasal high-frequency oscillatory ventilation, in a randomized trial of 206 preterm infants with respiratory failure.
Previous studies have supported the use of NHFOV as more effective for reducing CO2 and for lowering the risk of reintubation compared with NCPAP. But no randomized, controlled trials had compared the outcomes for preterm infants in particular, wrote Long Chen, MD, PhD, of Children’s Hospital of Chongqing Medical University, Chongqing, China, and colleagues.
Their study, published in Chest, was conducted at a single tertiary NICU in China between May 2017 and May 2018, and randomized infants with a gestational age less than 37 weeks to NHFOV (103 infants) or NCPAP (103 infants). Infants with major congenital abnormalities were excluded. The infants included 127 (61.7%) diagnosed with respiratory distress syndrome (RDS), 53 (25.7%) diagnosed with acute RDS (ARDS), and 26 (12.6%) diagnosed with both RDS and ARDS.
Overall, the reintubation rate within 6 hours was significantly lower among infants treated with NHFOV compared with those treated with NCPAP (15.5% vs. 34%, P = .002), and in the subset of infants with ARDS (23.5% vs. 52.6%, P = .032). Among infants with a gestational age of 32 weeks or less, reintuibation rates were also significantly lower among those treated with NHFOV (26.1% vs. 55.6%, P = .004).
In addition, PCO2 levels, 6 hours after extubation, were significantly lower among infants on NHFOV, compared with those on NCPAP (49.6 vs. 56.9 P = .00). The hospital stay, a secondary outcome, was significantly shorter among the infants treated with NHFOV, than those treated with NCPAP (22 days, vs. 27.6 days, P =.011).
Although the researchers observed some nasal trauma in NHFOV-treated patients, and intestinal dilation in both groups similar to side effects seen in previous studies, no feeding intolerance or skin lesions were associated with NHFOV. The study findings were consistent with those from previous studies, and suggested that the causes of respiratory failure might account for the differences between the treatment groups, they noted.
“RDS is primarily restrictive in the acute phase, and the high frequency oscillation over CPAP does not therefore bring any benefit. However, ARDS is both restrictive and obstructive in the acute phase due to the nature of ARDS,” and NHFOV is “able to improve oxygenation,” they added.
The study findings were limited by several factors including the use of data from a single center and the small number of infants younger than 28 weeks’ gestation, the researchers noted. However, they added, two international, multicenter, randomized controlled trials are in the works.
The study was supported by Social Livelihood Program of 38 Chongqing Science and Technology Commission, China. The researchers had no financial conflicts to disclose.
SOURCE: Long C et al. Chest. 2019; 155(4): 740-8.
FROM CHEST
Earlier diagnosis, treatment needed to curb dramatic rise in neonatal HSV
A 56% increase in neonatal herpes simplex virus (HSV) infection over 7 years was determined as part of a retrospective, multistate, longitudinal cohort study using information collected from the MarketScan Medicaid Database, reported Sanjay Mahant, MD, of the University of Toronto, and his associates.
Comprehensive coordinated care – as well as public health strategies targeting disease prevention, early diagnosis, and treatment – are needed to manage the growing number of neonates diagnosed with HSV, Dr. Mahant and his colleagues said.
A total of 900 newborn Medicaid enrollees aged 0-28 days were chosen from 2,107,124 births for inclusion in the study. All patients, who were diagnosed with HSV infection during hospital admission, were born during Jan. 1, 2009–Dec. 31, 2015.
Susceptibility to primary HSV-1 infection among younger women has been attributed to an increase in oral sex practices over the past 2 decades, which is putting adolescents and young adults at greater risk of genital HSV-1 infection (J Infect Dis. 2007;196[12]:1852-9). As a result, more “primary or nonprimary genital HSV-1 infections among childbearing women” are believed to be the likely cause for the increasing numbers of neonatal HSV cases, the authors speculated, citing a recent study (J Infect Dis. 2014 Feb 1;209[3]:315-7).
HSV, a rare infection typically contracted immediately before or after birth, has both high morbidity and mortality rates; transmission rates “after exposure and during delivery increase from 2% in recurrent infection to 25% and 60% in nonprimary and primary infections, respectively,” Dr. Mahant and his colleagues noted.
Over the study period, disease incidence grew from 3.4/10,000 births in 2009 (1/2,941 births) to 5.3/10,000 births in 2015 (1/1,886 births).
Dr. Mahant and his associates noted several limitations in the study that might explain the increase in incidence.
ICD diagnosis codes, which they characterized as imperfect in their ability to correctly identify neonatal HSV infections, may have led researchers to include infants who were not actually infected or (less likely) to have excluded infants who were infected. States participating in the MarketScan Medicaid Database also may have changed over the study period. Incomplete follow-up after hospitalization made it impossible to track infants who had changed insurers, moved to other states, or died during the study. They also cautioned that outcomes may not be transferable to the general population because outcomes were specific to Medicaid enrollees.
The total cost for initial hospitalization and treatments provided during 6 months of follow-up was $60,620,431 ($87,602 median cost per patient) for the cohort of 900 infants. This is significant given that the authors reported a median length of stay of 18 days for initial hospitalization. Of the 846 patients discharged (54, or 6%, died during initial hospitalization), follow-up data was available for 692 (81%). A total of 316 (46%) infants required at least one subsequent visit to the emergency room, and another 112 (16%) experienced at least one hospital readmission.
That Dr. Mahant and his colleagues “observed high health care use and associated payments over the first 6 months, including and after hospitalization for neonatal HSV” suggests that there is a need for comprehensive, coordinated care once neonatal patients receive a diagnosis of HSV.
“Public health strategies that are targeted on disease prevention and early diagnosis and treatment are needed,” they advised.
The authors had no relevant financial disclosures. The study was funded by the National Institutes of Health.
SOURCE: Mahant S et al. Pediatrics. 2019 Mar. doi: 10.1542/peds.2018-3233.
The rise in herpes simplex virus cases among neonates reported by Mahant et al. is significant, but there are other possible explanations that warrant additional research, James Gaensbauer, MD, and Joseph A. Grubenhoff, MD, wrote in an accompanying editorial.
Among those explanations, Dr. Gaensbauer and Dr. Grubenhoff cite recommendations made nationally in 2013 to screen asymptomatic infants who had been exposed to HSV at the time of delivery as one possible factor elevating the number of cases being reported. More widespread use of polymerase chain reaction (PCR)–based diagnostic testing, which is reported to be more sensitive, also could play a role in increasing the number of cases being identified.
As part of a larger diagnostic “conundrum” challenging clinicians, the editorialists noted that, at present, there is no uniform consensus for performing HSV testing and providing empirical treatment. “Current recommendations from the American Academy of Pediatrics identify and emphasize the importance of recognition of the factors associated with increased likelihood of HSV infection but do not specify a more comprehensive (e.g., all febrile infants) strategy.” Stakeholders should build flexibility into their recommended treatment approaches for the benefit of practitioners operating on the front lines, they advised.
Ultimately, if the increase in incidence of neonatal HSV cases proves largely attributable to the changing behaviors of young women, who have been engaging more frequently in oral sex, as Dr. Mahant and his colleagues suggest, further research will be warranted, cautioned Dr. Gaensbauer and Dr. Grubenhoff.
“With their work, the authors contribute further nuance to a complicated and ongoing question: How do we correctly identify all infants with neonatal HSV in a timely manner while avoiding subjecting large numbers of children to unnecessary tests and empirical treatments?” This debate “is likely to be transformed by increasing availability of rapid PCR testing for HSV,” they said.
The “pathway to better clarity will depend on researchers and clinicians such as Mahant et al., who continue to provide important data and ask critical questions,” Dr. Gaensbauer and Dr. Grubenhoff concluded.
Dr. Gaensbauer and Dr. Grubenhoff are affiliated with the Denver Health Medical Center; the Children’s Hospital Colorado, Aurora; and the department of pediatrics at University of Colorado at Denver, Aurora. This is a summarization of their editorial, which accompanied the article by Mahant et al. (Pediatrics. 2019 Mar. doi: 10.1542/peds.2019-0159). They received no external funding and had no relevant financial disclosures.
The rise in herpes simplex virus cases among neonates reported by Mahant et al. is significant, but there are other possible explanations that warrant additional research, James Gaensbauer, MD, and Joseph A. Grubenhoff, MD, wrote in an accompanying editorial.
Among those explanations, Dr. Gaensbauer and Dr. Grubenhoff cite recommendations made nationally in 2013 to screen asymptomatic infants who had been exposed to HSV at the time of delivery as one possible factor elevating the number of cases being reported. More widespread use of polymerase chain reaction (PCR)–based diagnostic testing, which is reported to be more sensitive, also could play a role in increasing the number of cases being identified.
As part of a larger diagnostic “conundrum” challenging clinicians, the editorialists noted that, at present, there is no uniform consensus for performing HSV testing and providing empirical treatment. “Current recommendations from the American Academy of Pediatrics identify and emphasize the importance of recognition of the factors associated with increased likelihood of HSV infection but do not specify a more comprehensive (e.g., all febrile infants) strategy.” Stakeholders should build flexibility into their recommended treatment approaches for the benefit of practitioners operating on the front lines, they advised.
Ultimately, if the increase in incidence of neonatal HSV cases proves largely attributable to the changing behaviors of young women, who have been engaging more frequently in oral sex, as Dr. Mahant and his colleagues suggest, further research will be warranted, cautioned Dr. Gaensbauer and Dr. Grubenhoff.
“With their work, the authors contribute further nuance to a complicated and ongoing question: How do we correctly identify all infants with neonatal HSV in a timely manner while avoiding subjecting large numbers of children to unnecessary tests and empirical treatments?” This debate “is likely to be transformed by increasing availability of rapid PCR testing for HSV,” they said.
The “pathway to better clarity will depend on researchers and clinicians such as Mahant et al., who continue to provide important data and ask critical questions,” Dr. Gaensbauer and Dr. Grubenhoff concluded.
Dr. Gaensbauer and Dr. Grubenhoff are affiliated with the Denver Health Medical Center; the Children’s Hospital Colorado, Aurora; and the department of pediatrics at University of Colorado at Denver, Aurora. This is a summarization of their editorial, which accompanied the article by Mahant et al. (Pediatrics. 2019 Mar. doi: 10.1542/peds.2019-0159). They received no external funding and had no relevant financial disclosures.
The rise in herpes simplex virus cases among neonates reported by Mahant et al. is significant, but there are other possible explanations that warrant additional research, James Gaensbauer, MD, and Joseph A. Grubenhoff, MD, wrote in an accompanying editorial.
Among those explanations, Dr. Gaensbauer and Dr. Grubenhoff cite recommendations made nationally in 2013 to screen asymptomatic infants who had been exposed to HSV at the time of delivery as one possible factor elevating the number of cases being reported. More widespread use of polymerase chain reaction (PCR)–based diagnostic testing, which is reported to be more sensitive, also could play a role in increasing the number of cases being identified.
As part of a larger diagnostic “conundrum” challenging clinicians, the editorialists noted that, at present, there is no uniform consensus for performing HSV testing and providing empirical treatment. “Current recommendations from the American Academy of Pediatrics identify and emphasize the importance of recognition of the factors associated with increased likelihood of HSV infection but do not specify a more comprehensive (e.g., all febrile infants) strategy.” Stakeholders should build flexibility into their recommended treatment approaches for the benefit of practitioners operating on the front lines, they advised.
Ultimately, if the increase in incidence of neonatal HSV cases proves largely attributable to the changing behaviors of young women, who have been engaging more frequently in oral sex, as Dr. Mahant and his colleagues suggest, further research will be warranted, cautioned Dr. Gaensbauer and Dr. Grubenhoff.
“With their work, the authors contribute further nuance to a complicated and ongoing question: How do we correctly identify all infants with neonatal HSV in a timely manner while avoiding subjecting large numbers of children to unnecessary tests and empirical treatments?” This debate “is likely to be transformed by increasing availability of rapid PCR testing for HSV,” they said.
The “pathway to better clarity will depend on researchers and clinicians such as Mahant et al., who continue to provide important data and ask critical questions,” Dr. Gaensbauer and Dr. Grubenhoff concluded.
Dr. Gaensbauer and Dr. Grubenhoff are affiliated with the Denver Health Medical Center; the Children’s Hospital Colorado, Aurora; and the department of pediatrics at University of Colorado at Denver, Aurora. This is a summarization of their editorial, which accompanied the article by Mahant et al. (Pediatrics. 2019 Mar. doi: 10.1542/peds.2019-0159). They received no external funding and had no relevant financial disclosures.
A 56% increase in neonatal herpes simplex virus (HSV) infection over 7 years was determined as part of a retrospective, multistate, longitudinal cohort study using information collected from the MarketScan Medicaid Database, reported Sanjay Mahant, MD, of the University of Toronto, and his associates.
Comprehensive coordinated care – as well as public health strategies targeting disease prevention, early diagnosis, and treatment – are needed to manage the growing number of neonates diagnosed with HSV, Dr. Mahant and his colleagues said.
A total of 900 newborn Medicaid enrollees aged 0-28 days were chosen from 2,107,124 births for inclusion in the study. All patients, who were diagnosed with HSV infection during hospital admission, were born during Jan. 1, 2009–Dec. 31, 2015.
Susceptibility to primary HSV-1 infection among younger women has been attributed to an increase in oral sex practices over the past 2 decades, which is putting adolescents and young adults at greater risk of genital HSV-1 infection (J Infect Dis. 2007;196[12]:1852-9). As a result, more “primary or nonprimary genital HSV-1 infections among childbearing women” are believed to be the likely cause for the increasing numbers of neonatal HSV cases, the authors speculated, citing a recent study (J Infect Dis. 2014 Feb 1;209[3]:315-7).
HSV, a rare infection typically contracted immediately before or after birth, has both high morbidity and mortality rates; transmission rates “after exposure and during delivery increase from 2% in recurrent infection to 25% and 60% in nonprimary and primary infections, respectively,” Dr. Mahant and his colleagues noted.
Over the study period, disease incidence grew from 3.4/10,000 births in 2009 (1/2,941 births) to 5.3/10,000 births in 2015 (1/1,886 births).
Dr. Mahant and his associates noted several limitations in the study that might explain the increase in incidence.
ICD diagnosis codes, which they characterized as imperfect in their ability to correctly identify neonatal HSV infections, may have led researchers to include infants who were not actually infected or (less likely) to have excluded infants who were infected. States participating in the MarketScan Medicaid Database also may have changed over the study period. Incomplete follow-up after hospitalization made it impossible to track infants who had changed insurers, moved to other states, or died during the study. They also cautioned that outcomes may not be transferable to the general population because outcomes were specific to Medicaid enrollees.
The total cost for initial hospitalization and treatments provided during 6 months of follow-up was $60,620,431 ($87,602 median cost per patient) for the cohort of 900 infants. This is significant given that the authors reported a median length of stay of 18 days for initial hospitalization. Of the 846 patients discharged (54, or 6%, died during initial hospitalization), follow-up data was available for 692 (81%). A total of 316 (46%) infants required at least one subsequent visit to the emergency room, and another 112 (16%) experienced at least one hospital readmission.
That Dr. Mahant and his colleagues “observed high health care use and associated payments over the first 6 months, including and after hospitalization for neonatal HSV” suggests that there is a need for comprehensive, coordinated care once neonatal patients receive a diagnosis of HSV.
“Public health strategies that are targeted on disease prevention and early diagnosis and treatment are needed,” they advised.
The authors had no relevant financial disclosures. The study was funded by the National Institutes of Health.
SOURCE: Mahant S et al. Pediatrics. 2019 Mar. doi: 10.1542/peds.2018-3233.
A 56% increase in neonatal herpes simplex virus (HSV) infection over 7 years was determined as part of a retrospective, multistate, longitudinal cohort study using information collected from the MarketScan Medicaid Database, reported Sanjay Mahant, MD, of the University of Toronto, and his associates.
Comprehensive coordinated care – as well as public health strategies targeting disease prevention, early diagnosis, and treatment – are needed to manage the growing number of neonates diagnosed with HSV, Dr. Mahant and his colleagues said.
A total of 900 newborn Medicaid enrollees aged 0-28 days were chosen from 2,107,124 births for inclusion in the study. All patients, who were diagnosed with HSV infection during hospital admission, were born during Jan. 1, 2009–Dec. 31, 2015.
Susceptibility to primary HSV-1 infection among younger women has been attributed to an increase in oral sex practices over the past 2 decades, which is putting adolescents and young adults at greater risk of genital HSV-1 infection (J Infect Dis. 2007;196[12]:1852-9). As a result, more “primary or nonprimary genital HSV-1 infections among childbearing women” are believed to be the likely cause for the increasing numbers of neonatal HSV cases, the authors speculated, citing a recent study (J Infect Dis. 2014 Feb 1;209[3]:315-7).
HSV, a rare infection typically contracted immediately before or after birth, has both high morbidity and mortality rates; transmission rates “after exposure and during delivery increase from 2% in recurrent infection to 25% and 60% in nonprimary and primary infections, respectively,” Dr. Mahant and his colleagues noted.
Over the study period, disease incidence grew from 3.4/10,000 births in 2009 (1/2,941 births) to 5.3/10,000 births in 2015 (1/1,886 births).
Dr. Mahant and his associates noted several limitations in the study that might explain the increase in incidence.
ICD diagnosis codes, which they characterized as imperfect in their ability to correctly identify neonatal HSV infections, may have led researchers to include infants who were not actually infected or (less likely) to have excluded infants who were infected. States participating in the MarketScan Medicaid Database also may have changed over the study period. Incomplete follow-up after hospitalization made it impossible to track infants who had changed insurers, moved to other states, or died during the study. They also cautioned that outcomes may not be transferable to the general population because outcomes were specific to Medicaid enrollees.
The total cost for initial hospitalization and treatments provided during 6 months of follow-up was $60,620,431 ($87,602 median cost per patient) for the cohort of 900 infants. This is significant given that the authors reported a median length of stay of 18 days for initial hospitalization. Of the 846 patients discharged (54, or 6%, died during initial hospitalization), follow-up data was available for 692 (81%). A total of 316 (46%) infants required at least one subsequent visit to the emergency room, and another 112 (16%) experienced at least one hospital readmission.
That Dr. Mahant and his colleagues “observed high health care use and associated payments over the first 6 months, including and after hospitalization for neonatal HSV” suggests that there is a need for comprehensive, coordinated care once neonatal patients receive a diagnosis of HSV.
“Public health strategies that are targeted on disease prevention and early diagnosis and treatment are needed,” they advised.
The authors had no relevant financial disclosures. The study was funded by the National Institutes of Health.
SOURCE: Mahant S et al. Pediatrics. 2019 Mar. doi: 10.1542/peds.2018-3233.
FROM PEDIATRICS
Swedish strategies improve survival for premature infants
based on data from a study of two cohorts including 2,205 births at 22-26 weeks’ gestational age.
The impact of the recommendations has not been well studied, wrote Mikael Norman, MD, PhD, of the Karolinska Institutet, Stockholm, and his colleagues in JAMA. To determine the impact, the researchers compared data from 1,009 births at 22-26 weeks’ gestational age during 2004-2007 with 1,196 births at 22-26 weeks’ gestational age during 2014-2016, after the implementation of guidelines on “centralization of care, antenatal corticosteroid treatment, mode of delivery, a neonatologist attending at the birth, and resuscitation of infants delivered at 22, 23, and 24 weeks’ gestational age.”
The 1-year survival increased from 70% during 2004-2007 to 77% during 2014-2016; a significant improvement (P = .003).
In addition, 1-year survival with no major morbidity improved significantly between the two time periods, from 32% to 38%, respectively (P = .008).
The mothers and infants were part of EXPRESS (Extremely Preterm Infants in Sweden Study), a national, population-based, prospective cohort study. In most cases, gestational age was determined by routine antenatal ultrasound early in the second trimester, or by date of embryo transfer in cases of in vitro fertilization. The primary outcome was survival at the age of 1 year; the secondary outcome was survival at 1 year with no major neonatal comorbidity.
Among premature infants who survived at 1 year, some conditions were significantly more prevalent in the earlier birth cohort, compared with the later cohort, notably cystic periventricular leukomalacia (6% vs. 2%), any bronchopulmonary dysplasia (73% vs. 62%), and severe bronchopulmonary dysplasia (25% vs. 14%).
Although the proportion of premature births with a neonatologist attending was similar between the two cohorts, significantly more premature infants were born outside of university hospitals and transported to a level III neonatal ICU after birth during 2004-2007, compared with 2014-2016, the researchers noted.
The study findings were limited by several factors including the retrospective design of the second cohort, inability to account for fetal losses prior to 22 weeks’ gestational age, lack of data on the causes of fetal and infant deaths, potentially unknown confounding variables that impacted infant survival, and the small sample size of some gestational age groups, the researchers noted. However, the results show improvements in 1-year survival in the wake of specific guidelines on perinatal management.
Dr. Norman reported receiving grants from the Swedish Heart Lung Foundation and the H2020/European Union, as well as personal fees from a Swedish medical journal, the Swedish patient insurance, Liber, Studentlitteratur, and AbbVie. The study was funded by the Swedish Order of Freemasons’ Foundation for Children’s Welfare.
SOURCE: Norman M et al. JAMA. 2019;321:1188-99.
The wide variation in outcomes for preterm birth worldwide raise questions as to whether the success seen in Sweden is possible in other countries, Matthew A. Rysavy, MD, PhD, and Danielle E. Y. Ehret, MD, MPH, wrote in an accompanying editorial. Considerations include population demographics, current guidelines, gestational age at which intensive care is offered, and the nature of follow-up care.
Sweden already has low rates of perinatal mortality, and current guidelines call for use of antenatal corticosteroids for births at 22 weeks’ gestation. By contrast, in the United States, antenatal corticosteroids are not recommended until 23-24 weeks’ gestation, they noted.
The editorialists called particular attention to the improvements in survival at 1 year and survival without major morbidity at 22-23 weeks’ gestation. “At 22 weeks’ gestation, the stillbirth rate decreased from 65% of all births during 2004-2007 to 35% during 2014-2016, with a reciprocal increase in live births.”
Although the results are promising, and show the possibilities for improving survival, the editorialists wrote that ongoing follow up of children born prematurely is essential to inform future research, as “much remains unknown about the later-life effects of being born so early and of the therapies used to sustain life after birth.”
Dr. Rysavy is affiliated with the department of pediatrics at the University of Iowa, Iowa City; Dr. Ehret is affiliated with the department of pediatrics at the University of Vermont, Burlington. This is a summary of their editorial accompanying the article by Norman et al. (JAMA. 2019 Mar 26;321:1163-64). They reported no financial conflicts.
The wide variation in outcomes for preterm birth worldwide raise questions as to whether the success seen in Sweden is possible in other countries, Matthew A. Rysavy, MD, PhD, and Danielle E. Y. Ehret, MD, MPH, wrote in an accompanying editorial. Considerations include population demographics, current guidelines, gestational age at which intensive care is offered, and the nature of follow-up care.
Sweden already has low rates of perinatal mortality, and current guidelines call for use of antenatal corticosteroids for births at 22 weeks’ gestation. By contrast, in the United States, antenatal corticosteroids are not recommended until 23-24 weeks’ gestation, they noted.
The editorialists called particular attention to the improvements in survival at 1 year and survival without major morbidity at 22-23 weeks’ gestation. “At 22 weeks’ gestation, the stillbirth rate decreased from 65% of all births during 2004-2007 to 35% during 2014-2016, with a reciprocal increase in live births.”
Although the results are promising, and show the possibilities for improving survival, the editorialists wrote that ongoing follow up of children born prematurely is essential to inform future research, as “much remains unknown about the later-life effects of being born so early and of the therapies used to sustain life after birth.”
Dr. Rysavy is affiliated with the department of pediatrics at the University of Iowa, Iowa City; Dr. Ehret is affiliated with the department of pediatrics at the University of Vermont, Burlington. This is a summary of their editorial accompanying the article by Norman et al. (JAMA. 2019 Mar 26;321:1163-64). They reported no financial conflicts.
The wide variation in outcomes for preterm birth worldwide raise questions as to whether the success seen in Sweden is possible in other countries, Matthew A. Rysavy, MD, PhD, and Danielle E. Y. Ehret, MD, MPH, wrote in an accompanying editorial. Considerations include population demographics, current guidelines, gestational age at which intensive care is offered, and the nature of follow-up care.
Sweden already has low rates of perinatal mortality, and current guidelines call for use of antenatal corticosteroids for births at 22 weeks’ gestation. By contrast, in the United States, antenatal corticosteroids are not recommended until 23-24 weeks’ gestation, they noted.
The editorialists called particular attention to the improvements in survival at 1 year and survival without major morbidity at 22-23 weeks’ gestation. “At 22 weeks’ gestation, the stillbirth rate decreased from 65% of all births during 2004-2007 to 35% during 2014-2016, with a reciprocal increase in live births.”
Although the results are promising, and show the possibilities for improving survival, the editorialists wrote that ongoing follow up of children born prematurely is essential to inform future research, as “much remains unknown about the later-life effects of being born so early and of the therapies used to sustain life after birth.”
Dr. Rysavy is affiliated with the department of pediatrics at the University of Iowa, Iowa City; Dr. Ehret is affiliated with the department of pediatrics at the University of Vermont, Burlington. This is a summary of their editorial accompanying the article by Norman et al. (JAMA. 2019 Mar 26;321:1163-64). They reported no financial conflicts.
based on data from a study of two cohorts including 2,205 births at 22-26 weeks’ gestational age.
The impact of the recommendations has not been well studied, wrote Mikael Norman, MD, PhD, of the Karolinska Institutet, Stockholm, and his colleagues in JAMA. To determine the impact, the researchers compared data from 1,009 births at 22-26 weeks’ gestational age during 2004-2007 with 1,196 births at 22-26 weeks’ gestational age during 2014-2016, after the implementation of guidelines on “centralization of care, antenatal corticosteroid treatment, mode of delivery, a neonatologist attending at the birth, and resuscitation of infants delivered at 22, 23, and 24 weeks’ gestational age.”
The 1-year survival increased from 70% during 2004-2007 to 77% during 2014-2016; a significant improvement (P = .003).
In addition, 1-year survival with no major morbidity improved significantly between the two time periods, from 32% to 38%, respectively (P = .008).
The mothers and infants were part of EXPRESS (Extremely Preterm Infants in Sweden Study), a national, population-based, prospective cohort study. In most cases, gestational age was determined by routine antenatal ultrasound early in the second trimester, or by date of embryo transfer in cases of in vitro fertilization. The primary outcome was survival at the age of 1 year; the secondary outcome was survival at 1 year with no major neonatal comorbidity.
Among premature infants who survived at 1 year, some conditions were significantly more prevalent in the earlier birth cohort, compared with the later cohort, notably cystic periventricular leukomalacia (6% vs. 2%), any bronchopulmonary dysplasia (73% vs. 62%), and severe bronchopulmonary dysplasia (25% vs. 14%).
Although the proportion of premature births with a neonatologist attending was similar between the two cohorts, significantly more premature infants were born outside of university hospitals and transported to a level III neonatal ICU after birth during 2004-2007, compared with 2014-2016, the researchers noted.
The study findings were limited by several factors including the retrospective design of the second cohort, inability to account for fetal losses prior to 22 weeks’ gestational age, lack of data on the causes of fetal and infant deaths, potentially unknown confounding variables that impacted infant survival, and the small sample size of some gestational age groups, the researchers noted. However, the results show improvements in 1-year survival in the wake of specific guidelines on perinatal management.
Dr. Norman reported receiving grants from the Swedish Heart Lung Foundation and the H2020/European Union, as well as personal fees from a Swedish medical journal, the Swedish patient insurance, Liber, Studentlitteratur, and AbbVie. The study was funded by the Swedish Order of Freemasons’ Foundation for Children’s Welfare.
SOURCE: Norman M et al. JAMA. 2019;321:1188-99.
based on data from a study of two cohorts including 2,205 births at 22-26 weeks’ gestational age.
The impact of the recommendations has not been well studied, wrote Mikael Norman, MD, PhD, of the Karolinska Institutet, Stockholm, and his colleagues in JAMA. To determine the impact, the researchers compared data from 1,009 births at 22-26 weeks’ gestational age during 2004-2007 with 1,196 births at 22-26 weeks’ gestational age during 2014-2016, after the implementation of guidelines on “centralization of care, antenatal corticosteroid treatment, mode of delivery, a neonatologist attending at the birth, and resuscitation of infants delivered at 22, 23, and 24 weeks’ gestational age.”
The 1-year survival increased from 70% during 2004-2007 to 77% during 2014-2016; a significant improvement (P = .003).
In addition, 1-year survival with no major morbidity improved significantly between the two time periods, from 32% to 38%, respectively (P = .008).
The mothers and infants were part of EXPRESS (Extremely Preterm Infants in Sweden Study), a national, population-based, prospective cohort study. In most cases, gestational age was determined by routine antenatal ultrasound early in the second trimester, or by date of embryo transfer in cases of in vitro fertilization. The primary outcome was survival at the age of 1 year; the secondary outcome was survival at 1 year with no major neonatal comorbidity.
Among premature infants who survived at 1 year, some conditions were significantly more prevalent in the earlier birth cohort, compared with the later cohort, notably cystic periventricular leukomalacia (6% vs. 2%), any bronchopulmonary dysplasia (73% vs. 62%), and severe bronchopulmonary dysplasia (25% vs. 14%).
Although the proportion of premature births with a neonatologist attending was similar between the two cohorts, significantly more premature infants were born outside of university hospitals and transported to a level III neonatal ICU after birth during 2004-2007, compared with 2014-2016, the researchers noted.
The study findings were limited by several factors including the retrospective design of the second cohort, inability to account for fetal losses prior to 22 weeks’ gestational age, lack of data on the causes of fetal and infant deaths, potentially unknown confounding variables that impacted infant survival, and the small sample size of some gestational age groups, the researchers noted. However, the results show improvements in 1-year survival in the wake of specific guidelines on perinatal management.
Dr. Norman reported receiving grants from the Swedish Heart Lung Foundation and the H2020/European Union, as well as personal fees from a Swedish medical journal, the Swedish patient insurance, Liber, Studentlitteratur, and AbbVie. The study was funded by the Swedish Order of Freemasons’ Foundation for Children’s Welfare.
SOURCE: Norman M et al. JAMA. 2019;321:1188-99.
FROM JAMA
Antenatal steroids for preterm birth is cost effective
Administering antenatal corticosteroids to pregnant women at high risk for preterm birth was a cost-effective intervention that improved infant respiratory outcomes, according to a new study.
“This intervention has a potential cost saving in the United States of approximately $100 million dollars annually from the benefit in the immediate neonatal outcome alone,” Cynthia Gyamfi-Bannerman, MD, of Columbia University, New York, and her associates reported in JAMA Pediatrics. “Because late preterm birth comprises a large proportion of all preterm births, our findings have the potential for a large influence on public health.”
The researchers conducted a retrospective secondary analysis of the randomized Antenatal Late Preterm Steroids (ALPS) clinical trial October 2010 to February 2015. The trial enrolled randomly assigned antenatal administration of betamethasone or placebo to women pregnant with a singleton and at high risk for preterm birth while between 34 weeks, 6 days, and 36 weeks, 0 days, of gestation.
Antenatal corticosteroid administration was regarded as effective if a newborn did not require treatment in the first 72 hours for respiratory distress or illness. Treatment could include “continuous positive airway pressure or high-flow nasal cannula for 2 hours or more, supplemental oxygen with a fraction of inspired oxygen of 30% or more for 4 hours or more, and extracorporeal membrane oxygenation or mechanical ventilation,” Dr. Gyamfi-Bannerman and her associates wrote.
To tally the costs, the researchers used Medicaid rates to estimate the total in 2015 U.S. dollars for betamethasone, outpatient visits or inpatient stays to administer it, and all direct newborn care costs, including neonatal ICU daily costs stratified by respiratory illness severity. Betamethasone administration included an initial 12-mg intramuscular dose followed by another after 24 hours if the infant had not been delivered.
“Because therapy often persists for longer than this 72-hour duration, we measured costs through hospital discharge,” the authors wrote. “The analysis took the perspective of a third-party payer in which we included direct medical costs and associated overhead accruing to hospitals and medical payers for the care of enrolled patients and their infants.”
Among 2,821 mothers not lost to follow-up during the secondary analysis, 1,426 received betamethasone and 1,395 received placebo. For mothers who received betamethasone antenatally, the total mean cost was $4,681 per mother-infant pair. Total mean cost for those in the placebo group was $5,379 per pair, resulting in a significant mean $698 savings (P = .02). Respiratory morbidity was 2.9% lower in infants whose mothers received antenatal corticosteroid treatment.
“Thus, because the treated group had lower costs and this strategy was more effective, administration of betamethasone to women at risk for late preterm birth was judged to be a dominant strategy, which is defined as one in which costs are lower and effectiveness is higher than a comparator (incremental cost-effectiveness ratio [ICER], −23 986),” Dr. Gyamfi-Bannerman and her associates reported. ICER is defined as the difference in mean total cost per patient in the betamethasone and placebo arms divided by the difference in the effectiveness.
Study limitations were an inability to estimate costs according to quality-adjusted life years or to include families’/caregivers’ costs.
SOURCE: Gyamfi-Bannerman C. JAMA Pediatr. 2019 Mar 11. doi: 10.1001/jamapediatrics.2019.0032.
Administering antenatal corticosteroids to pregnant women at high risk for preterm birth was a cost-effective intervention that improved infant respiratory outcomes, according to a new study.
“This intervention has a potential cost saving in the United States of approximately $100 million dollars annually from the benefit in the immediate neonatal outcome alone,” Cynthia Gyamfi-Bannerman, MD, of Columbia University, New York, and her associates reported in JAMA Pediatrics. “Because late preterm birth comprises a large proportion of all preterm births, our findings have the potential for a large influence on public health.”
The researchers conducted a retrospective secondary analysis of the randomized Antenatal Late Preterm Steroids (ALPS) clinical trial October 2010 to February 2015. The trial enrolled randomly assigned antenatal administration of betamethasone or placebo to women pregnant with a singleton and at high risk for preterm birth while between 34 weeks, 6 days, and 36 weeks, 0 days, of gestation.
Antenatal corticosteroid administration was regarded as effective if a newborn did not require treatment in the first 72 hours for respiratory distress or illness. Treatment could include “continuous positive airway pressure or high-flow nasal cannula for 2 hours or more, supplemental oxygen with a fraction of inspired oxygen of 30% or more for 4 hours or more, and extracorporeal membrane oxygenation or mechanical ventilation,” Dr. Gyamfi-Bannerman and her associates wrote.
To tally the costs, the researchers used Medicaid rates to estimate the total in 2015 U.S. dollars for betamethasone, outpatient visits or inpatient stays to administer it, and all direct newborn care costs, including neonatal ICU daily costs stratified by respiratory illness severity. Betamethasone administration included an initial 12-mg intramuscular dose followed by another after 24 hours if the infant had not been delivered.
“Because therapy often persists for longer than this 72-hour duration, we measured costs through hospital discharge,” the authors wrote. “The analysis took the perspective of a third-party payer in which we included direct medical costs and associated overhead accruing to hospitals and medical payers for the care of enrolled patients and their infants.”
Among 2,821 mothers not lost to follow-up during the secondary analysis, 1,426 received betamethasone and 1,395 received placebo. For mothers who received betamethasone antenatally, the total mean cost was $4,681 per mother-infant pair. Total mean cost for those in the placebo group was $5,379 per pair, resulting in a significant mean $698 savings (P = .02). Respiratory morbidity was 2.9% lower in infants whose mothers received antenatal corticosteroid treatment.
“Thus, because the treated group had lower costs and this strategy was more effective, administration of betamethasone to women at risk for late preterm birth was judged to be a dominant strategy, which is defined as one in which costs are lower and effectiveness is higher than a comparator (incremental cost-effectiveness ratio [ICER], −23 986),” Dr. Gyamfi-Bannerman and her associates reported. ICER is defined as the difference in mean total cost per patient in the betamethasone and placebo arms divided by the difference in the effectiveness.
Study limitations were an inability to estimate costs according to quality-adjusted life years or to include families’/caregivers’ costs.
SOURCE: Gyamfi-Bannerman C. JAMA Pediatr. 2019 Mar 11. doi: 10.1001/jamapediatrics.2019.0032.
Administering antenatal corticosteroids to pregnant women at high risk for preterm birth was a cost-effective intervention that improved infant respiratory outcomes, according to a new study.
“This intervention has a potential cost saving in the United States of approximately $100 million dollars annually from the benefit in the immediate neonatal outcome alone,” Cynthia Gyamfi-Bannerman, MD, of Columbia University, New York, and her associates reported in JAMA Pediatrics. “Because late preterm birth comprises a large proportion of all preterm births, our findings have the potential for a large influence on public health.”
The researchers conducted a retrospective secondary analysis of the randomized Antenatal Late Preterm Steroids (ALPS) clinical trial October 2010 to February 2015. The trial enrolled randomly assigned antenatal administration of betamethasone or placebo to women pregnant with a singleton and at high risk for preterm birth while between 34 weeks, 6 days, and 36 weeks, 0 days, of gestation.
Antenatal corticosteroid administration was regarded as effective if a newborn did not require treatment in the first 72 hours for respiratory distress or illness. Treatment could include “continuous positive airway pressure or high-flow nasal cannula for 2 hours or more, supplemental oxygen with a fraction of inspired oxygen of 30% or more for 4 hours or more, and extracorporeal membrane oxygenation or mechanical ventilation,” Dr. Gyamfi-Bannerman and her associates wrote.
To tally the costs, the researchers used Medicaid rates to estimate the total in 2015 U.S. dollars for betamethasone, outpatient visits or inpatient stays to administer it, and all direct newborn care costs, including neonatal ICU daily costs stratified by respiratory illness severity. Betamethasone administration included an initial 12-mg intramuscular dose followed by another after 24 hours if the infant had not been delivered.
“Because therapy often persists for longer than this 72-hour duration, we measured costs through hospital discharge,” the authors wrote. “The analysis took the perspective of a third-party payer in which we included direct medical costs and associated overhead accruing to hospitals and medical payers for the care of enrolled patients and their infants.”
Among 2,821 mothers not lost to follow-up during the secondary analysis, 1,426 received betamethasone and 1,395 received placebo. For mothers who received betamethasone antenatally, the total mean cost was $4,681 per mother-infant pair. Total mean cost for those in the placebo group was $5,379 per pair, resulting in a significant mean $698 savings (P = .02). Respiratory morbidity was 2.9% lower in infants whose mothers received antenatal corticosteroid treatment.
“Thus, because the treated group had lower costs and this strategy was more effective, administration of betamethasone to women at risk for late preterm birth was judged to be a dominant strategy, which is defined as one in which costs are lower and effectiveness is higher than a comparator (incremental cost-effectiveness ratio [ICER], −23 986),” Dr. Gyamfi-Bannerman and her associates reported. ICER is defined as the difference in mean total cost per patient in the betamethasone and placebo arms divided by the difference in the effectiveness.
Study limitations were an inability to estimate costs according to quality-adjusted life years or to include families’/caregivers’ costs.
SOURCE: Gyamfi-Bannerman C. JAMA Pediatr. 2019 Mar 11. doi: 10.1001/jamapediatrics.2019.0032.
FROM JAMA PEDIATRICS
New noninvasive wireless devices aim to more gently monitor neonatal vital signs
and lowering the risk of iatrogenic injuries, according to a series of tests on neonates in two level III NICUs.
“By eliminating wired connections, these platforms also facilitate therapeutic skin-to-skin contact between neonates and parents, which is known to stabilize vital signs, reduce morbidity, and promote parental bonding,” lead author Ha Uk Chung of the University of Illinois at Urbana-Champaign and coauthors wrote in Science.
In an effort to replace current wired systems that rigidly attach to fragile neonate skin, the investigators created a pair of ultrathin, noninvasive devices that can capture and transmit full vital signs with clinical-grade precision. One of the devices is mounted on the chest and captures ECGs; the other records photoplethysmograms from the base of the foot. That data plus skin temperature is wirelessly transmitted and used to measure heart rate, respiration rate, blood oxygenation, and systolic blood pressure via pulse arrival time.
The devices were tested on neonates in two level III NICUs; the infants had gestational ages ranging from 28 weeks to full term, and the results “demonstrate[d] the full range of functions,” the investigators noted. Because the devices are smaller and lighter, they interface with infant skin with forces that are “nearly an order of magnitude smaller” than adhesives used with conventional NICU measuring systems. The coauthors also noted that these cost-effective systems have potential uses beyond typical hospital settings, including “potential relevance to global health.”
No conflicts of interest were reported.
SOURCE: Chung HU et al. Science. 2019 Mar 1. doi: 10.1126/science.aau0780.
and lowering the risk of iatrogenic injuries, according to a series of tests on neonates in two level III NICUs.
“By eliminating wired connections, these platforms also facilitate therapeutic skin-to-skin contact between neonates and parents, which is known to stabilize vital signs, reduce morbidity, and promote parental bonding,” lead author Ha Uk Chung of the University of Illinois at Urbana-Champaign and coauthors wrote in Science.
In an effort to replace current wired systems that rigidly attach to fragile neonate skin, the investigators created a pair of ultrathin, noninvasive devices that can capture and transmit full vital signs with clinical-grade precision. One of the devices is mounted on the chest and captures ECGs; the other records photoplethysmograms from the base of the foot. That data plus skin temperature is wirelessly transmitted and used to measure heart rate, respiration rate, blood oxygenation, and systolic blood pressure via pulse arrival time.
The devices were tested on neonates in two level III NICUs; the infants had gestational ages ranging from 28 weeks to full term, and the results “demonstrate[d] the full range of functions,” the investigators noted. Because the devices are smaller and lighter, they interface with infant skin with forces that are “nearly an order of magnitude smaller” than adhesives used with conventional NICU measuring systems. The coauthors also noted that these cost-effective systems have potential uses beyond typical hospital settings, including “potential relevance to global health.”
No conflicts of interest were reported.
SOURCE: Chung HU et al. Science. 2019 Mar 1. doi: 10.1126/science.aau0780.
and lowering the risk of iatrogenic injuries, according to a series of tests on neonates in two level III NICUs.
“By eliminating wired connections, these platforms also facilitate therapeutic skin-to-skin contact between neonates and parents, which is known to stabilize vital signs, reduce morbidity, and promote parental bonding,” lead author Ha Uk Chung of the University of Illinois at Urbana-Champaign and coauthors wrote in Science.
In an effort to replace current wired systems that rigidly attach to fragile neonate skin, the investigators created a pair of ultrathin, noninvasive devices that can capture and transmit full vital signs with clinical-grade precision. One of the devices is mounted on the chest and captures ECGs; the other records photoplethysmograms from the base of the foot. That data plus skin temperature is wirelessly transmitted and used to measure heart rate, respiration rate, blood oxygenation, and systolic blood pressure via pulse arrival time.
The devices were tested on neonates in two level III NICUs; the infants had gestational ages ranging from 28 weeks to full term, and the results “demonstrate[d] the full range of functions,” the investigators noted. Because the devices are smaller and lighter, they interface with infant skin with forces that are “nearly an order of magnitude smaller” than adhesives used with conventional NICU measuring systems. The coauthors also noted that these cost-effective systems have potential uses beyond typical hospital settings, including “potential relevance to global health.”
No conflicts of interest were reported.
SOURCE: Chung HU et al. Science. 2019 Mar 1. doi: 10.1126/science.aau0780.
FROM SCIENCE
Insulin-treated diabetes in pregnancy carries preterm risk
Women with insulin-treated diabetes are at significantly greater risk of preterm birth and of delivering babies who are large for gestational age (LGA), regardless of prepregnancy body weight, new findings suggest.
Researchers examined the role of maternal diabetes and weight on pregnancy outcomes in the population-based cohort study. The study comprised 649,043 live births in Finland between Jan. 1, 2004, and Dec. 31, 2014, including 4,000 in women with insulin-treated diabetes, 3,740 in women with type 2 diabetes, and 98,568 women with gestational diabetes.
Prepregnancy body mass index was normal for nearly 60% of mothers, while 4% were underweight, 21% were overweight, 8% were moderately obese, and 4% were severely obese.
Overall, the researchers found that women with insulin-treated diabetes had a 43-fold higher odds of having an LGA infant, compared with the reference group of women of normal BMI without diabetes (adjusted odds ratio [aOR], 43.80; 95% confidence interval, 40.88-46.93). And there was an 11-fold greater odds of having a preterm birth in this group (aOR, 11.17; 95% CI, 10.46-11.93).
The findings were published in JAMA Pediatrics.
“Smaller, but clearly statistically significant, increased LGA risks were found also for mothers with type 2 diabetes and gestational diabetes not treated with insulin, especially in combination with prepregnancy overweight or obesity that were stronger for type 2 diabetes than gestational diabetes,” wrote Linghua Kong, MSc, of the department of molecular medicine and surgery at Karolinska Institutet, and coauthors.
The aOR for LGA among women with type 2 diabetes was 9.57 (95% CI, 8.65-10.58), compared with the reference group. And for women with maternal gestational diabetes, the aOR for LGA was 3.80 (95% CI, 3.66-3.96).
Looking at the risk for preterm birth, the researchers found that the aOR among women with type 2 diabetes was 2.12 (95% CI, 1.90-2.36), while there was no association between gestational diabetes and preterm birth.
The researchers also reported that for women with gestational diabetes or no diabetes, the odds of preterm birth increased slightly as maternal prepregnancy BMI increased.
“Maternal glucose metabolism during pregnancy differs from that in the non-pregnant state; insulin resistance is increased, directing fat as the mother’s energy source to ensure adequate carbohydrate supply for the growing fetus,” the researchers wrote. “This increase in insulin resistance is mediated by a number of factors, such as increased levels of progesterone, estrogen, and human placental lactogen.”
The authors noted that their data did not include information on congenital anomalies, maternal complications such as preeclampsia, and grade of diabetes control during pregnancy. In addition, the data on maternal BMI was derived from a single time point.
“These findings may have implications for counseling and managing pregnancies to prevent adverse birth outcomes,” they wrote.
The study and some authors were supported by the THL National Institute for Health and Welfare, the Swedish Research Council, Stockholm County Council, the China Scholarship Council, and the Swedish Brain Foundation.
SOURCE: Kong L et al. JAMA Pediatr. 2019 Feb 25. doi: 10.1001/jamapediatrics.2018.5541.
Women with insulin-treated diabetes are at significantly greater risk of preterm birth and of delivering babies who are large for gestational age (LGA), regardless of prepregnancy body weight, new findings suggest.
Researchers examined the role of maternal diabetes and weight on pregnancy outcomes in the population-based cohort study. The study comprised 649,043 live births in Finland between Jan. 1, 2004, and Dec. 31, 2014, including 4,000 in women with insulin-treated diabetes, 3,740 in women with type 2 diabetes, and 98,568 women with gestational diabetes.
Prepregnancy body mass index was normal for nearly 60% of mothers, while 4% were underweight, 21% were overweight, 8% were moderately obese, and 4% were severely obese.
Overall, the researchers found that women with insulin-treated diabetes had a 43-fold higher odds of having an LGA infant, compared with the reference group of women of normal BMI without diabetes (adjusted odds ratio [aOR], 43.80; 95% confidence interval, 40.88-46.93). And there was an 11-fold greater odds of having a preterm birth in this group (aOR, 11.17; 95% CI, 10.46-11.93).
The findings were published in JAMA Pediatrics.
“Smaller, but clearly statistically significant, increased LGA risks were found also for mothers with type 2 diabetes and gestational diabetes not treated with insulin, especially in combination with prepregnancy overweight or obesity that were stronger for type 2 diabetes than gestational diabetes,” wrote Linghua Kong, MSc, of the department of molecular medicine and surgery at Karolinska Institutet, and coauthors.
The aOR for LGA among women with type 2 diabetes was 9.57 (95% CI, 8.65-10.58), compared with the reference group. And for women with maternal gestational diabetes, the aOR for LGA was 3.80 (95% CI, 3.66-3.96).
Looking at the risk for preterm birth, the researchers found that the aOR among women with type 2 diabetes was 2.12 (95% CI, 1.90-2.36), while there was no association between gestational diabetes and preterm birth.
The researchers also reported that for women with gestational diabetes or no diabetes, the odds of preterm birth increased slightly as maternal prepregnancy BMI increased.
“Maternal glucose metabolism during pregnancy differs from that in the non-pregnant state; insulin resistance is increased, directing fat as the mother’s energy source to ensure adequate carbohydrate supply for the growing fetus,” the researchers wrote. “This increase in insulin resistance is mediated by a number of factors, such as increased levels of progesterone, estrogen, and human placental lactogen.”
The authors noted that their data did not include information on congenital anomalies, maternal complications such as preeclampsia, and grade of diabetes control during pregnancy. In addition, the data on maternal BMI was derived from a single time point.
“These findings may have implications for counseling and managing pregnancies to prevent adverse birth outcomes,” they wrote.
The study and some authors were supported by the THL National Institute for Health and Welfare, the Swedish Research Council, Stockholm County Council, the China Scholarship Council, and the Swedish Brain Foundation.
SOURCE: Kong L et al. JAMA Pediatr. 2019 Feb 25. doi: 10.1001/jamapediatrics.2018.5541.
Women with insulin-treated diabetes are at significantly greater risk of preterm birth and of delivering babies who are large for gestational age (LGA), regardless of prepregnancy body weight, new findings suggest.
Researchers examined the role of maternal diabetes and weight on pregnancy outcomes in the population-based cohort study. The study comprised 649,043 live births in Finland between Jan. 1, 2004, and Dec. 31, 2014, including 4,000 in women with insulin-treated diabetes, 3,740 in women with type 2 diabetes, and 98,568 women with gestational diabetes.
Prepregnancy body mass index was normal for nearly 60% of mothers, while 4% were underweight, 21% were overweight, 8% were moderately obese, and 4% were severely obese.
Overall, the researchers found that women with insulin-treated diabetes had a 43-fold higher odds of having an LGA infant, compared with the reference group of women of normal BMI without diabetes (adjusted odds ratio [aOR], 43.80; 95% confidence interval, 40.88-46.93). And there was an 11-fold greater odds of having a preterm birth in this group (aOR, 11.17; 95% CI, 10.46-11.93).
The findings were published in JAMA Pediatrics.
“Smaller, but clearly statistically significant, increased LGA risks were found also for mothers with type 2 diabetes and gestational diabetes not treated with insulin, especially in combination with prepregnancy overweight or obesity that were stronger for type 2 diabetes than gestational diabetes,” wrote Linghua Kong, MSc, of the department of molecular medicine and surgery at Karolinska Institutet, and coauthors.
The aOR for LGA among women with type 2 diabetes was 9.57 (95% CI, 8.65-10.58), compared with the reference group. And for women with maternal gestational diabetes, the aOR for LGA was 3.80 (95% CI, 3.66-3.96).
Looking at the risk for preterm birth, the researchers found that the aOR among women with type 2 diabetes was 2.12 (95% CI, 1.90-2.36), while there was no association between gestational diabetes and preterm birth.
The researchers also reported that for women with gestational diabetes or no diabetes, the odds of preterm birth increased slightly as maternal prepregnancy BMI increased.
“Maternal glucose metabolism during pregnancy differs from that in the non-pregnant state; insulin resistance is increased, directing fat as the mother’s energy source to ensure adequate carbohydrate supply for the growing fetus,” the researchers wrote. “This increase in insulin resistance is mediated by a number of factors, such as increased levels of progesterone, estrogen, and human placental lactogen.”
The authors noted that their data did not include information on congenital anomalies, maternal complications such as preeclampsia, and grade of diabetes control during pregnancy. In addition, the data on maternal BMI was derived from a single time point.
“These findings may have implications for counseling and managing pregnancies to prevent adverse birth outcomes,” they wrote.
The study and some authors were supported by the THL National Institute for Health and Welfare, the Swedish Research Council, Stockholm County Council, the China Scholarship Council, and the Swedish Brain Foundation.
SOURCE: Kong L et al. JAMA Pediatr. 2019 Feb 25. doi: 10.1001/jamapediatrics.2018.5541.
FROM JAMA PEDIATRICS
Key clinical point:
Major finding: Pregnant women with insulin-treated diabetes have a 43-fold higher odds of having a child who is large for gestational age and 11-fold high risk for preterm birth.
Study details: A population-based cohort study of 649,043 live births in Finland between 2004 and 2014.
Disclosures: The study and some authors were supported by the THL National Institute for Health and Welfare, the Swedish Research Council, Stockholm County Council, the China Scholarship Council, and the Swedish Brain Foundation.
Source: Kong L et al. JAMA Pediatr. 2019 Feb 25. doi: 10.1001/jamapediatrics.2018.5541.
Umbilical cord milking tied to severe IVH in very premature neonates
Delayed cord clamping and cutting is safer
LAS VEGAS – Umbilical cord milking can cause severe intraventricular hemorrhage (IVH) in very premature neonates and should not be performed on these cerebrovascularly fragile premature babies.
Just six of these procedures would be needed to cause a case of severe IVH in neonates born at 23-27 weeks’ gestation, Michael W. Varner, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“Centers practicing umbilical cord milking should consider discontinuing this practice in infants 23-27 weeks’ gestation,” said Dr. Varner of the University of Utah, Salt Lake City.
The damage to the brains of very young preemies appears to be a direct result of the fluid overload caused by milking, he said. “From a mechanistic perspective, we can intuit that these findings are consistent with cord milking. This causes increasing venous return to the right atrium where it enters the foramen ovale and aorta. These very premature babies have more pulmonary vasoconstriction, which shunts more blood toward the brain. This results in fluctuations in flow in an immature brain with fragile germinal matrices and perhaps further compromised by chorioamnionitis inflammation, resulting in IVH.”
Premature Infants Receiving Milking or Delayed Cord Clamping (PREMOD2) was a noninferiority trial of umbilical cord milking compared to delayed cord clamping and cutting in preterm infants. Conducted at 11 sites in the United States and Europe, the study was halted prematurely when the data safety monitoring board determined that cord milking increased the risk of IVH in younger preemies and was no better than delayed cutting in the older preemies. The analysis presented at the meeting is the first public discussion of the data details.
The trial involved 474 premature neonates. They were randomized to placental transfusion via a 60-second delay in cord clamping and cutting or to umbilical cord milking, which involved grasping the cord and manually pushing the cord blood toward the infant four times before clamping. All participating sites received a video demonstrating the proper procedure. The cohort also was divided by gestational age: 23-27 weeks and 28-31 weeks.
The primary endpoint was a combination of severe IVH (grade 3 or higher) and neonatal death. Overall, the primary endpoint occurred in 29 of those randomized to cord milking (12%) and 20 randomized to delayed clamping (8%) – a significant difference.
This finding was largely driven by the treatment differences in the 23-27 week group, Dr. Varner said. Severe IVH occurred in 20 (22%) of those randomized to cord milking and five (6%) of those randomized to delayed clamping – a highly statistically significant difference with a P value of 0.0019.
In the 28-31 week group, there were no cases of severe IVH in the cord milking group, and three cases in the delayed clamping group; the difference was not statistically significant.
Overall, deaths were similar between the cord milking and cord clamping groups (17 and 15, respectively). Most of these deaths occurred in the younger group (14 in the cord milking group and 13 in the clamping group). There were five deaths in the older group: three in the cord milking group and two in the clamping group. None of these differences were statistically significant.
After seeing these data in a preplanned interim safety analysis, the Data Safety Monitoring Board stopped the study, saying that the intervention appeared dangerous for the younger babies, and no better than the delayed cutting and clamping for the older group, Dr. Varner said.
Since the trial was halted, investigators have been dissecting the data to identify any other intracranial hemorrhage risks particular to the infants. They found no significant differences in maternal characteristics at baseline, and – other than age and randomization– nothing significantly different between the infant groups. Severe persistent IVH occurred in almost 70% of the infants born at 23 weeks’ gestation but in only 7% in the delayed cord clamping group. The risks declined rapidly with increasing gestational age, although they were at all times greater than the risk of IVH in the cord clamping group.
“Looking at the data by gestational age, it’s clear that the majority of the severe IVH occurrences were in the 23 weekers, and also occurred in the first 7 days of life,” Dr. Varner said.
The cohort will be followed for at least another year, he added, as investigators track neurodevelopmental outcomes.
Investigators are particularly interested in differences in motor and language skills, as well as general cognitive development.
The study was sponsored by theEunice Kennedy Shriver National Institute of Child Health and Development. Neither Dr. Varner nor any of the coauthors had any financial declarations.
SOURCE: Katheria AC et al. The Pregnancy Meeting, late breaking abstract 1.
Delayed cord clamping and cutting is safer
Delayed cord clamping and cutting is safer
LAS VEGAS – Umbilical cord milking can cause severe intraventricular hemorrhage (IVH) in very premature neonates and should not be performed on these cerebrovascularly fragile premature babies.
Just six of these procedures would be needed to cause a case of severe IVH in neonates born at 23-27 weeks’ gestation, Michael W. Varner, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“Centers practicing umbilical cord milking should consider discontinuing this practice in infants 23-27 weeks’ gestation,” said Dr. Varner of the University of Utah, Salt Lake City.
The damage to the brains of very young preemies appears to be a direct result of the fluid overload caused by milking, he said. “From a mechanistic perspective, we can intuit that these findings are consistent with cord milking. This causes increasing venous return to the right atrium where it enters the foramen ovale and aorta. These very premature babies have more pulmonary vasoconstriction, which shunts more blood toward the brain. This results in fluctuations in flow in an immature brain with fragile germinal matrices and perhaps further compromised by chorioamnionitis inflammation, resulting in IVH.”
Premature Infants Receiving Milking or Delayed Cord Clamping (PREMOD2) was a noninferiority trial of umbilical cord milking compared to delayed cord clamping and cutting in preterm infants. Conducted at 11 sites in the United States and Europe, the study was halted prematurely when the data safety monitoring board determined that cord milking increased the risk of IVH in younger preemies and was no better than delayed cutting in the older preemies. The analysis presented at the meeting is the first public discussion of the data details.
The trial involved 474 premature neonates. They were randomized to placental transfusion via a 60-second delay in cord clamping and cutting or to umbilical cord milking, which involved grasping the cord and manually pushing the cord blood toward the infant four times before clamping. All participating sites received a video demonstrating the proper procedure. The cohort also was divided by gestational age: 23-27 weeks and 28-31 weeks.
The primary endpoint was a combination of severe IVH (grade 3 or higher) and neonatal death. Overall, the primary endpoint occurred in 29 of those randomized to cord milking (12%) and 20 randomized to delayed clamping (8%) – a significant difference.
This finding was largely driven by the treatment differences in the 23-27 week group, Dr. Varner said. Severe IVH occurred in 20 (22%) of those randomized to cord milking and five (6%) of those randomized to delayed clamping – a highly statistically significant difference with a P value of 0.0019.
In the 28-31 week group, there were no cases of severe IVH in the cord milking group, and three cases in the delayed clamping group; the difference was not statistically significant.
Overall, deaths were similar between the cord milking and cord clamping groups (17 and 15, respectively). Most of these deaths occurred in the younger group (14 in the cord milking group and 13 in the clamping group). There were five deaths in the older group: three in the cord milking group and two in the clamping group. None of these differences were statistically significant.
After seeing these data in a preplanned interim safety analysis, the Data Safety Monitoring Board stopped the study, saying that the intervention appeared dangerous for the younger babies, and no better than the delayed cutting and clamping for the older group, Dr. Varner said.
Since the trial was halted, investigators have been dissecting the data to identify any other intracranial hemorrhage risks particular to the infants. They found no significant differences in maternal characteristics at baseline, and – other than age and randomization– nothing significantly different between the infant groups. Severe persistent IVH occurred in almost 70% of the infants born at 23 weeks’ gestation but in only 7% in the delayed cord clamping group. The risks declined rapidly with increasing gestational age, although they were at all times greater than the risk of IVH in the cord clamping group.
“Looking at the data by gestational age, it’s clear that the majority of the severe IVH occurrences were in the 23 weekers, and also occurred in the first 7 days of life,” Dr. Varner said.
The cohort will be followed for at least another year, he added, as investigators track neurodevelopmental outcomes.
Investigators are particularly interested in differences in motor and language skills, as well as general cognitive development.
The study was sponsored by theEunice Kennedy Shriver National Institute of Child Health and Development. Neither Dr. Varner nor any of the coauthors had any financial declarations.
SOURCE: Katheria AC et al. The Pregnancy Meeting, late breaking abstract 1.
LAS VEGAS – Umbilical cord milking can cause severe intraventricular hemorrhage (IVH) in very premature neonates and should not be performed on these cerebrovascularly fragile premature babies.
Just six of these procedures would be needed to cause a case of severe IVH in neonates born at 23-27 weeks’ gestation, Michael W. Varner, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“Centers practicing umbilical cord milking should consider discontinuing this practice in infants 23-27 weeks’ gestation,” said Dr. Varner of the University of Utah, Salt Lake City.
The damage to the brains of very young preemies appears to be a direct result of the fluid overload caused by milking, he said. “From a mechanistic perspective, we can intuit that these findings are consistent with cord milking. This causes increasing venous return to the right atrium where it enters the foramen ovale and aorta. These very premature babies have more pulmonary vasoconstriction, which shunts more blood toward the brain. This results in fluctuations in flow in an immature brain with fragile germinal matrices and perhaps further compromised by chorioamnionitis inflammation, resulting in IVH.”
Premature Infants Receiving Milking or Delayed Cord Clamping (PREMOD2) was a noninferiority trial of umbilical cord milking compared to delayed cord clamping and cutting in preterm infants. Conducted at 11 sites in the United States and Europe, the study was halted prematurely when the data safety monitoring board determined that cord milking increased the risk of IVH in younger preemies and was no better than delayed cutting in the older preemies. The analysis presented at the meeting is the first public discussion of the data details.
The trial involved 474 premature neonates. They were randomized to placental transfusion via a 60-second delay in cord clamping and cutting or to umbilical cord milking, which involved grasping the cord and manually pushing the cord blood toward the infant four times before clamping. All participating sites received a video demonstrating the proper procedure. The cohort also was divided by gestational age: 23-27 weeks and 28-31 weeks.
The primary endpoint was a combination of severe IVH (grade 3 or higher) and neonatal death. Overall, the primary endpoint occurred in 29 of those randomized to cord milking (12%) and 20 randomized to delayed clamping (8%) – a significant difference.
This finding was largely driven by the treatment differences in the 23-27 week group, Dr. Varner said. Severe IVH occurred in 20 (22%) of those randomized to cord milking and five (6%) of those randomized to delayed clamping – a highly statistically significant difference with a P value of 0.0019.
In the 28-31 week group, there were no cases of severe IVH in the cord milking group, and three cases in the delayed clamping group; the difference was not statistically significant.
Overall, deaths were similar between the cord milking and cord clamping groups (17 and 15, respectively). Most of these deaths occurred in the younger group (14 in the cord milking group and 13 in the clamping group). There were five deaths in the older group: three in the cord milking group and two in the clamping group. None of these differences were statistically significant.
After seeing these data in a preplanned interim safety analysis, the Data Safety Monitoring Board stopped the study, saying that the intervention appeared dangerous for the younger babies, and no better than the delayed cutting and clamping for the older group, Dr. Varner said.
Since the trial was halted, investigators have been dissecting the data to identify any other intracranial hemorrhage risks particular to the infants. They found no significant differences in maternal characteristics at baseline, and – other than age and randomization– nothing significantly different between the infant groups. Severe persistent IVH occurred in almost 70% of the infants born at 23 weeks’ gestation but in only 7% in the delayed cord clamping group. The risks declined rapidly with increasing gestational age, although they were at all times greater than the risk of IVH in the cord clamping group.
“Looking at the data by gestational age, it’s clear that the majority of the severe IVH occurrences were in the 23 weekers, and also occurred in the first 7 days of life,” Dr. Varner said.
The cohort will be followed for at least another year, he added, as investigators track neurodevelopmental outcomes.
Investigators are particularly interested in differences in motor and language skills, as well as general cognitive development.
The study was sponsored by theEunice Kennedy Shriver National Institute of Child Health and Development. Neither Dr. Varner nor any of the coauthors had any financial declarations.
SOURCE: Katheria AC et al. The Pregnancy Meeting, late breaking abstract 1.
REPORTING FROM THE PREGNANCY MEETING
Buprenorphine for NAS shows promise in reducing length of stay
In what is believed to be the first study of its kind to compare all available pharmacologic treatment options for relief of symptoms associated with neonatal abstinence syndrome (NAS), buprenorphine has the greatest probability of reducing duration of treatment and length of stay among newborns, reported Timothy Disher, PhD, of Dalhousie University School of Nursing, Halifax, N.S., and his associates.
It was noteworthy that the study also found morphine and phenobarbital monotherapies to be worst in overall effectiveness and ranking because these pharmacotherapies are the most frequently used treatments in the United States, according to the authors. Dr. Disher and his associates underscored the need for concern over the common rationale of treatment centers, especially in using phenobarbital, since the American Academy of Pediatrics “highlights that phenobarbital is most commonly used only as adjuvant therapy” and was not intended as a first-line treatment.
In their efforts to identify treatments that are most effective at easing the symptoms of NAS, Dr. Disher and his colleagues conducted a systematic review and network meta-analysis in June 2018, which included a search of the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, and the Web of Science Core Collection. In addition, they referenced ClinicalTrials.gov to identify relevant ongoing trials. Studies ultimately included in the review were randomized clinical trials comparing at least two pharmacotherapies prescribed for NAS that had been published in peer-reviewed journals.
Eighteen studies examining treatment for NAS among 1,072 newborns, including 10 studies published since 2000, were identified; the remaining studies were published between 1977 and 1986. Altogether, eight treatment interventions were examined across 10 studies
Dr. Disher and his associates reported that, during 2004-2014, there was a fivefold increase in the number of babies presenting with NAS, from 1.5/1,000 live births to 8.0/1,000, which represented a sevenfold increase in treatment cost in the Medicaid population during the same period, from $65.4 million to $462 million.
Although Dr. Disher and his colleagues acknowledged that buprenorphine was identified as best treatment by median ranks, “the ranks for most treatments are imprecise,” they said. According to results of their analysis, buprenorphine was associated with a reduction in 2.19 days of treatment, compared with clonidine, and 12.75 days, compared with morphine. In terms of secondary outcomes, buprenorphine was associated with a reduction in length of stay of 5.35 days, compared with clonidine, and 11.43 days, compared with morphine.
Seven of the studies evaluated (n = 394) included infants requiring adjuvant treatment. Agthe et al. reported that no infants in the concomitant diluted tincture of opium (DTO) and clonidine arm needed adjuvant treatment compared with five infants in the DTO-only arm who did. Surran et al. reported 2 of 32 infants who failed attempts to wean in the concomitant morphine and clonidine group compared with none of the 34 who were in the morphine and phenobarbital group.
In terms of adverse events, one study reported a seizure that was unrelated to treatment (Kraft et al). Agthe et al. reported three infants experiencing seizure in the DTO-only group compared with no infants who received concomitant clonidine. In Surran et al., three infants receiving concomitant phenobarbital and morphine were reported to be oversedated.
In general, the rationale explaining differences in why pharmacologic therapies affect treatment length is underdeveloped, the authors said. Buprenorphine, in particular, is favored because of its ease of dosing schedule and the possible improved safety profile given its longer half-life and greater micro-opioid receptor activity. It has been further suggested that the prolonged half-life of buprenorphine may be responsible for preventing sudden withdrawal symptoms. The researchers found no significant adverse events associated with buprenorphine treatment.
Although there were differences across buprenorphine treatment protocols, Dr. Disher and his colleagues noted that they were “broadly similar.” The authors conceded, however, that there is reason to question “how much of the observed improvement in buprenorphine may be attributable to the differences in optimization of the treatment and weaning protocols.”
Based on findings in this review, the authors caution that it is unlikely “that the current evidence base is sufficient to recommend specific large-scale changes in treatment away from the current standard of care.”
Despite recent research, which proposes trying nonpharmacologic treatments first and incorporating shared rooms for families and infants to reduce length of stay when treatment is required, up to 70% of infants ultimately require pharmacologic treatment. When drug therapy is needed, the average length of stay and overall treatment costs double, 10.9 vs. 22 days and $20,708 vs. $44,720, respectively.
Since results of the analysis show benefit, however variable, in reducing the length of treatment, “continued efforts to identify the optimal pharmacological agents are justified,” urged Dr. Disher and his associates.
Ultimately, before buprenorphine can be considered as a universally accepted standard of care in the treatment of NAS, “a large multisite pragmatic trial that compares buprenorphine with other treatments” will be needed.
One of the researchers – Chris Cameron, PhD – is an employee and holds shares of the Cornerstone Research Group, which provides consultant services to various pharmaceutical and device companies. Dr. Disher is a subcontractor for the Cornerstone Research Group. There were no other disclosures to report.
SOURCE: Disher T et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2018.5044.
Most of the 50%-80% of newborns treated for NAS are treated pharmacologically in newborn ICUs at significant cost ($93,400 for mean stay of 23 days). To date, the wide variations in care, including pharmacologic options for treating NAS, leave clinicians with no consensus regarding which medication is best. The further absence of high-quality studies that depict effective management strategies for NAS offers “little guidance to inform best practice recommendations,” Elisha M. Wachman, MD, and Martha M. Werler, DSc, wrote in an editorial published with the study.
The network analysis approach followed by Disher et al. requires some assumptions, namely “minimal bias and homogeneity of methods,” the authors observed. Yet, some of the randomized, clinical trials included in their evaluation were “not blinded and thus carry high risk of bias.” In addition, given the varied methods employed across the studies cited, “the primary findings of this meta-analysis warrant further discussion.”
Disher et al. concede that the benefits afforded with buprenorphine treatment could be more pronounced because of the dosing and weaning methods rather than from the effect of the medicine alone. Given that some studies cited did experience a shorter absolute median length of treatment with morphine, it is possible that the shortened lengths of treatment and stay concerning buprenorphine treatment “may be overestimates,” suggested Dr. Wachman and Dr. Werler.
Because of the extent of variability across studies cited, “results of the network meta-analysis by Disher et al. should be interpreted with caution.” It is worth noting that most of the studies evaluated did not “examine long-term outcomes beyond the initial birth hospitalization.” The question is: Does shorter length of treatment lead to improved long-term outcomes, or “does it put the infant at risk for readmission and altered neurobehavior and development?”
Although the researchers provide evidence of buprenorphine’s effectiveness in significantly shortening length of treatment, compared with morphine, “results should be interpreted with caution given the small number of RCTs, small sample sizes, heterogeneous methods and study populations, and lack of long-term outcome data.”
Dr. Wachman is affiliated with the department of pediatrics, Boston Medical Center. Dr. Werler is chair of the department of epidemiology, Boston University School of Public Health. The authors were supported by a grant from the National Institute of Child Health and Human Development. Dr. Werler also is supported by a grant from the Centers for Disease Control and Prevention/Massachusetts Department of Public Health. This editorial accompanied the article by Disher et al. (JAMA Pediatrics. 2019. doi: 10. 1001/jamapediatric.2018.5029).
Most of the 50%-80% of newborns treated for NAS are treated pharmacologically in newborn ICUs at significant cost ($93,400 for mean stay of 23 days). To date, the wide variations in care, including pharmacologic options for treating NAS, leave clinicians with no consensus regarding which medication is best. The further absence of high-quality studies that depict effective management strategies for NAS offers “little guidance to inform best practice recommendations,” Elisha M. Wachman, MD, and Martha M. Werler, DSc, wrote in an editorial published with the study.
The network analysis approach followed by Disher et al. requires some assumptions, namely “minimal bias and homogeneity of methods,” the authors observed. Yet, some of the randomized, clinical trials included in their evaluation were “not blinded and thus carry high risk of bias.” In addition, given the varied methods employed across the studies cited, “the primary findings of this meta-analysis warrant further discussion.”
Disher et al. concede that the benefits afforded with buprenorphine treatment could be more pronounced because of the dosing and weaning methods rather than from the effect of the medicine alone. Given that some studies cited did experience a shorter absolute median length of treatment with morphine, it is possible that the shortened lengths of treatment and stay concerning buprenorphine treatment “may be overestimates,” suggested Dr. Wachman and Dr. Werler.
Because of the extent of variability across studies cited, “results of the network meta-analysis by Disher et al. should be interpreted with caution.” It is worth noting that most of the studies evaluated did not “examine long-term outcomes beyond the initial birth hospitalization.” The question is: Does shorter length of treatment lead to improved long-term outcomes, or “does it put the infant at risk for readmission and altered neurobehavior and development?”
Although the researchers provide evidence of buprenorphine’s effectiveness in significantly shortening length of treatment, compared with morphine, “results should be interpreted with caution given the small number of RCTs, small sample sizes, heterogeneous methods and study populations, and lack of long-term outcome data.”
Dr. Wachman is affiliated with the department of pediatrics, Boston Medical Center. Dr. Werler is chair of the department of epidemiology, Boston University School of Public Health. The authors were supported by a grant from the National Institute of Child Health and Human Development. Dr. Werler also is supported by a grant from the Centers for Disease Control and Prevention/Massachusetts Department of Public Health. This editorial accompanied the article by Disher et al. (JAMA Pediatrics. 2019. doi: 10. 1001/jamapediatric.2018.5029).
Most of the 50%-80% of newborns treated for NAS are treated pharmacologically in newborn ICUs at significant cost ($93,400 for mean stay of 23 days). To date, the wide variations in care, including pharmacologic options for treating NAS, leave clinicians with no consensus regarding which medication is best. The further absence of high-quality studies that depict effective management strategies for NAS offers “little guidance to inform best practice recommendations,” Elisha M. Wachman, MD, and Martha M. Werler, DSc, wrote in an editorial published with the study.
The network analysis approach followed by Disher et al. requires some assumptions, namely “minimal bias and homogeneity of methods,” the authors observed. Yet, some of the randomized, clinical trials included in their evaluation were “not blinded and thus carry high risk of bias.” In addition, given the varied methods employed across the studies cited, “the primary findings of this meta-analysis warrant further discussion.”
Disher et al. concede that the benefits afforded with buprenorphine treatment could be more pronounced because of the dosing and weaning methods rather than from the effect of the medicine alone. Given that some studies cited did experience a shorter absolute median length of treatment with morphine, it is possible that the shortened lengths of treatment and stay concerning buprenorphine treatment “may be overestimates,” suggested Dr. Wachman and Dr. Werler.
Because of the extent of variability across studies cited, “results of the network meta-analysis by Disher et al. should be interpreted with caution.” It is worth noting that most of the studies evaluated did not “examine long-term outcomes beyond the initial birth hospitalization.” The question is: Does shorter length of treatment lead to improved long-term outcomes, or “does it put the infant at risk for readmission and altered neurobehavior and development?”
Although the researchers provide evidence of buprenorphine’s effectiveness in significantly shortening length of treatment, compared with morphine, “results should be interpreted with caution given the small number of RCTs, small sample sizes, heterogeneous methods and study populations, and lack of long-term outcome data.”
Dr. Wachman is affiliated with the department of pediatrics, Boston Medical Center. Dr. Werler is chair of the department of epidemiology, Boston University School of Public Health. The authors were supported by a grant from the National Institute of Child Health and Human Development. Dr. Werler also is supported by a grant from the Centers for Disease Control and Prevention/Massachusetts Department of Public Health. This editorial accompanied the article by Disher et al. (JAMA Pediatrics. 2019. doi: 10. 1001/jamapediatric.2018.5029).
In what is believed to be the first study of its kind to compare all available pharmacologic treatment options for relief of symptoms associated with neonatal abstinence syndrome (NAS), buprenorphine has the greatest probability of reducing duration of treatment and length of stay among newborns, reported Timothy Disher, PhD, of Dalhousie University School of Nursing, Halifax, N.S., and his associates.
It was noteworthy that the study also found morphine and phenobarbital monotherapies to be worst in overall effectiveness and ranking because these pharmacotherapies are the most frequently used treatments in the United States, according to the authors. Dr. Disher and his associates underscored the need for concern over the common rationale of treatment centers, especially in using phenobarbital, since the American Academy of Pediatrics “highlights that phenobarbital is most commonly used only as adjuvant therapy” and was not intended as a first-line treatment.
In their efforts to identify treatments that are most effective at easing the symptoms of NAS, Dr. Disher and his colleagues conducted a systematic review and network meta-analysis in June 2018, which included a search of the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, and the Web of Science Core Collection. In addition, they referenced ClinicalTrials.gov to identify relevant ongoing trials. Studies ultimately included in the review were randomized clinical trials comparing at least two pharmacotherapies prescribed for NAS that had been published in peer-reviewed journals.
Eighteen studies examining treatment for NAS among 1,072 newborns, including 10 studies published since 2000, were identified; the remaining studies were published between 1977 and 1986. Altogether, eight treatment interventions were examined across 10 studies
Dr. Disher and his associates reported that, during 2004-2014, there was a fivefold increase in the number of babies presenting with NAS, from 1.5/1,000 live births to 8.0/1,000, which represented a sevenfold increase in treatment cost in the Medicaid population during the same period, from $65.4 million to $462 million.
Although Dr. Disher and his colleagues acknowledged that buprenorphine was identified as best treatment by median ranks, “the ranks for most treatments are imprecise,” they said. According to results of their analysis, buprenorphine was associated with a reduction in 2.19 days of treatment, compared with clonidine, and 12.75 days, compared with morphine. In terms of secondary outcomes, buprenorphine was associated with a reduction in length of stay of 5.35 days, compared with clonidine, and 11.43 days, compared with morphine.
Seven of the studies evaluated (n = 394) included infants requiring adjuvant treatment. Agthe et al. reported that no infants in the concomitant diluted tincture of opium (DTO) and clonidine arm needed adjuvant treatment compared with five infants in the DTO-only arm who did. Surran et al. reported 2 of 32 infants who failed attempts to wean in the concomitant morphine and clonidine group compared with none of the 34 who were in the morphine and phenobarbital group.
In terms of adverse events, one study reported a seizure that was unrelated to treatment (Kraft et al). Agthe et al. reported three infants experiencing seizure in the DTO-only group compared with no infants who received concomitant clonidine. In Surran et al., three infants receiving concomitant phenobarbital and morphine were reported to be oversedated.
In general, the rationale explaining differences in why pharmacologic therapies affect treatment length is underdeveloped, the authors said. Buprenorphine, in particular, is favored because of its ease of dosing schedule and the possible improved safety profile given its longer half-life and greater micro-opioid receptor activity. It has been further suggested that the prolonged half-life of buprenorphine may be responsible for preventing sudden withdrawal symptoms. The researchers found no significant adverse events associated with buprenorphine treatment.
Although there were differences across buprenorphine treatment protocols, Dr. Disher and his colleagues noted that they were “broadly similar.” The authors conceded, however, that there is reason to question “how much of the observed improvement in buprenorphine may be attributable to the differences in optimization of the treatment and weaning protocols.”
Based on findings in this review, the authors caution that it is unlikely “that the current evidence base is sufficient to recommend specific large-scale changes in treatment away from the current standard of care.”
Despite recent research, which proposes trying nonpharmacologic treatments first and incorporating shared rooms for families and infants to reduce length of stay when treatment is required, up to 70% of infants ultimately require pharmacologic treatment. When drug therapy is needed, the average length of stay and overall treatment costs double, 10.9 vs. 22 days and $20,708 vs. $44,720, respectively.
Since results of the analysis show benefit, however variable, in reducing the length of treatment, “continued efforts to identify the optimal pharmacological agents are justified,” urged Dr. Disher and his associates.
Ultimately, before buprenorphine can be considered as a universally accepted standard of care in the treatment of NAS, “a large multisite pragmatic trial that compares buprenorphine with other treatments” will be needed.
One of the researchers – Chris Cameron, PhD – is an employee and holds shares of the Cornerstone Research Group, which provides consultant services to various pharmaceutical and device companies. Dr. Disher is a subcontractor for the Cornerstone Research Group. There were no other disclosures to report.
SOURCE: Disher T et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2018.5044.
In what is believed to be the first study of its kind to compare all available pharmacologic treatment options for relief of symptoms associated with neonatal abstinence syndrome (NAS), buprenorphine has the greatest probability of reducing duration of treatment and length of stay among newborns, reported Timothy Disher, PhD, of Dalhousie University School of Nursing, Halifax, N.S., and his associates.
It was noteworthy that the study also found morphine and phenobarbital monotherapies to be worst in overall effectiveness and ranking because these pharmacotherapies are the most frequently used treatments in the United States, according to the authors. Dr. Disher and his associates underscored the need for concern over the common rationale of treatment centers, especially in using phenobarbital, since the American Academy of Pediatrics “highlights that phenobarbital is most commonly used only as adjuvant therapy” and was not intended as a first-line treatment.
In their efforts to identify treatments that are most effective at easing the symptoms of NAS, Dr. Disher and his colleagues conducted a systematic review and network meta-analysis in June 2018, which included a search of the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, and the Web of Science Core Collection. In addition, they referenced ClinicalTrials.gov to identify relevant ongoing trials. Studies ultimately included in the review were randomized clinical trials comparing at least two pharmacotherapies prescribed for NAS that had been published in peer-reviewed journals.
Eighteen studies examining treatment for NAS among 1,072 newborns, including 10 studies published since 2000, were identified; the remaining studies were published between 1977 and 1986. Altogether, eight treatment interventions were examined across 10 studies
Dr. Disher and his associates reported that, during 2004-2014, there was a fivefold increase in the number of babies presenting with NAS, from 1.5/1,000 live births to 8.0/1,000, which represented a sevenfold increase in treatment cost in the Medicaid population during the same period, from $65.4 million to $462 million.
Although Dr. Disher and his colleagues acknowledged that buprenorphine was identified as best treatment by median ranks, “the ranks for most treatments are imprecise,” they said. According to results of their analysis, buprenorphine was associated with a reduction in 2.19 days of treatment, compared with clonidine, and 12.75 days, compared with morphine. In terms of secondary outcomes, buprenorphine was associated with a reduction in length of stay of 5.35 days, compared with clonidine, and 11.43 days, compared with morphine.
Seven of the studies evaluated (n = 394) included infants requiring adjuvant treatment. Agthe et al. reported that no infants in the concomitant diluted tincture of opium (DTO) and clonidine arm needed adjuvant treatment compared with five infants in the DTO-only arm who did. Surran et al. reported 2 of 32 infants who failed attempts to wean in the concomitant morphine and clonidine group compared with none of the 34 who were in the morphine and phenobarbital group.
In terms of adverse events, one study reported a seizure that was unrelated to treatment (Kraft et al). Agthe et al. reported three infants experiencing seizure in the DTO-only group compared with no infants who received concomitant clonidine. In Surran et al., three infants receiving concomitant phenobarbital and morphine were reported to be oversedated.
In general, the rationale explaining differences in why pharmacologic therapies affect treatment length is underdeveloped, the authors said. Buprenorphine, in particular, is favored because of its ease of dosing schedule and the possible improved safety profile given its longer half-life and greater micro-opioid receptor activity. It has been further suggested that the prolonged half-life of buprenorphine may be responsible for preventing sudden withdrawal symptoms. The researchers found no significant adverse events associated with buprenorphine treatment.
Although there were differences across buprenorphine treatment protocols, Dr. Disher and his colleagues noted that they were “broadly similar.” The authors conceded, however, that there is reason to question “how much of the observed improvement in buprenorphine may be attributable to the differences in optimization of the treatment and weaning protocols.”
Based on findings in this review, the authors caution that it is unlikely “that the current evidence base is sufficient to recommend specific large-scale changes in treatment away from the current standard of care.”
Despite recent research, which proposes trying nonpharmacologic treatments first and incorporating shared rooms for families and infants to reduce length of stay when treatment is required, up to 70% of infants ultimately require pharmacologic treatment. When drug therapy is needed, the average length of stay and overall treatment costs double, 10.9 vs. 22 days and $20,708 vs. $44,720, respectively.
Since results of the analysis show benefit, however variable, in reducing the length of treatment, “continued efforts to identify the optimal pharmacological agents are justified,” urged Dr. Disher and his associates.
Ultimately, before buprenorphine can be considered as a universally accepted standard of care in the treatment of NAS, “a large multisite pragmatic trial that compares buprenorphine with other treatments” will be needed.
One of the researchers – Chris Cameron, PhD – is an employee and holds shares of the Cornerstone Research Group, which provides consultant services to various pharmaceutical and device companies. Dr. Disher is a subcontractor for the Cornerstone Research Group. There were no other disclosures to report.
SOURCE: Disher T et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2018.5044.
FROM JAMA PEDIATRICS
Key clinical point: A larger study comparing buprenorphine and morphine is needed to confirm study findings.
Major finding: Although morphine and phenobarbital are prescribed most frequently in the United States, they were found to be the least effective treatments available.
Study details: Systematic review and network meta-analysis.
Disclosures: The authors had no financial relationships relevant to this article to disclose.
Source: Disher T et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2018.5044.
Device approved to treat PDA in premature infants
weighing as little as 2 pounds.
PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.
FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.
“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.
Find the full press release on the Abbott website.
weighing as little as 2 pounds.
PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.
FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.
“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.
Find the full press release on the Abbott website.
weighing as little as 2 pounds.
PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.
FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.
“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.
Find the full press release on the Abbott website.
Intrapartum molecular GBS screening reduced newborn early-onset disease, antibiotic use
Point-of-care intrapartum molecular screening of group B Streptococcus reduced the incidence of early-onset disease cases and antibiotic use, according to research published in Obstetrics & Gynecology.
Najoua El Helali, PharmD, from the Service de Microbiologie Clinique at Groupe Hospitalier Paris Saint-Joseph, and her colleagues measured the rate of early-onset disease group B Streptococcus (GBS) in a single-center study analyzing antenatal culture screening for 4 years prior to implementation (2006-2009) of polymerase chain reaction (PCR) screening (2010-2015). There were 11,226 deliveries (11,818 live births) during the antenatal screening period and 18,835 deliveries (18,980 live births) during the PCR screening period. Overall, 4% of deliveries during the antenatal period and 0.1% of deliveries during the intrapartum period were not screened for GBS (P less than .001).
During 2006-2015, the rate of early-onset disease of GBS decreased to 0.21/1,000 cases from 1.01/1,000 cases (risk ratio, 0.25; 95% confidence interval, 0.14-0.43; P = .026), while the rate of probable early-onset disease GBS decreased to 0.73/1,000 cases from 2.8/1,000 cases (RR, 0.25; (95% CI, 0.14-0.43; P less than .001).
For patients with early-onset GBS, length of stay in hospital decreased by 64%, and antibiotic therapy decreased by 60%, but there was no significant difference in average length of stay or duration of antibiotic therapy during the study period. There was a reduction in annual delivery- and treatment-associated costs of early-onset disease GBS from $41,875 to $11,945, while the estimated extra cost of PCR screening to avoid one additional case of early-onset disease GBS was $5,819 and a cost increase of $49 per newborn.
“The additional PCR costs were offset in part by the reduction in early-onset GBS disease treatment costs,” the investigators said.
“A randomized, controlled multicenter study is probably needed to evaluate the cost-effectiveness of this prevention strategy and demonstrate a better efficacy in populations where poorly followed women are of unknown GBS status at presentation for delivery,” the researchers said. “In term newborns, however, using infection rate as an endpoint is problematic given the sample size needed.”
The researchers said their study was potentially limited by lack of a control group and population selection, and described mothers in their center as “mostly well-informed and well-monitored during their pregnancy.”
The authors reported no relevant conflicts of interest.
SOURCE: El Helali N et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003057.
Point-of-care intrapartum molecular screening of group B Streptococcus reduced the incidence of early-onset disease cases and antibiotic use, according to research published in Obstetrics & Gynecology.
Najoua El Helali, PharmD, from the Service de Microbiologie Clinique at Groupe Hospitalier Paris Saint-Joseph, and her colleagues measured the rate of early-onset disease group B Streptococcus (GBS) in a single-center study analyzing antenatal culture screening for 4 years prior to implementation (2006-2009) of polymerase chain reaction (PCR) screening (2010-2015). There were 11,226 deliveries (11,818 live births) during the antenatal screening period and 18,835 deliveries (18,980 live births) during the PCR screening period. Overall, 4% of deliveries during the antenatal period and 0.1% of deliveries during the intrapartum period were not screened for GBS (P less than .001).
During 2006-2015, the rate of early-onset disease of GBS decreased to 0.21/1,000 cases from 1.01/1,000 cases (risk ratio, 0.25; 95% confidence interval, 0.14-0.43; P = .026), while the rate of probable early-onset disease GBS decreased to 0.73/1,000 cases from 2.8/1,000 cases (RR, 0.25; (95% CI, 0.14-0.43; P less than .001).
For patients with early-onset GBS, length of stay in hospital decreased by 64%, and antibiotic therapy decreased by 60%, but there was no significant difference in average length of stay or duration of antibiotic therapy during the study period. There was a reduction in annual delivery- and treatment-associated costs of early-onset disease GBS from $41,875 to $11,945, while the estimated extra cost of PCR screening to avoid one additional case of early-onset disease GBS was $5,819 and a cost increase of $49 per newborn.
“The additional PCR costs were offset in part by the reduction in early-onset GBS disease treatment costs,” the investigators said.
“A randomized, controlled multicenter study is probably needed to evaluate the cost-effectiveness of this prevention strategy and demonstrate a better efficacy in populations where poorly followed women are of unknown GBS status at presentation for delivery,” the researchers said. “In term newborns, however, using infection rate as an endpoint is problematic given the sample size needed.”
The researchers said their study was potentially limited by lack of a control group and population selection, and described mothers in their center as “mostly well-informed and well-monitored during their pregnancy.”
The authors reported no relevant conflicts of interest.
SOURCE: El Helali N et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003057.
Point-of-care intrapartum molecular screening of group B Streptococcus reduced the incidence of early-onset disease cases and antibiotic use, according to research published in Obstetrics & Gynecology.
Najoua El Helali, PharmD, from the Service de Microbiologie Clinique at Groupe Hospitalier Paris Saint-Joseph, and her colleagues measured the rate of early-onset disease group B Streptococcus (GBS) in a single-center study analyzing antenatal culture screening for 4 years prior to implementation (2006-2009) of polymerase chain reaction (PCR) screening (2010-2015). There were 11,226 deliveries (11,818 live births) during the antenatal screening period and 18,835 deliveries (18,980 live births) during the PCR screening period. Overall, 4% of deliveries during the antenatal period and 0.1% of deliveries during the intrapartum period were not screened for GBS (P less than .001).
During 2006-2015, the rate of early-onset disease of GBS decreased to 0.21/1,000 cases from 1.01/1,000 cases (risk ratio, 0.25; 95% confidence interval, 0.14-0.43; P = .026), while the rate of probable early-onset disease GBS decreased to 0.73/1,000 cases from 2.8/1,000 cases (RR, 0.25; (95% CI, 0.14-0.43; P less than .001).
For patients with early-onset GBS, length of stay in hospital decreased by 64%, and antibiotic therapy decreased by 60%, but there was no significant difference in average length of stay or duration of antibiotic therapy during the study period. There was a reduction in annual delivery- and treatment-associated costs of early-onset disease GBS from $41,875 to $11,945, while the estimated extra cost of PCR screening to avoid one additional case of early-onset disease GBS was $5,819 and a cost increase of $49 per newborn.
“The additional PCR costs were offset in part by the reduction in early-onset GBS disease treatment costs,” the investigators said.
“A randomized, controlled multicenter study is probably needed to evaluate the cost-effectiveness of this prevention strategy and demonstrate a better efficacy in populations where poorly followed women are of unknown GBS status at presentation for delivery,” the researchers said. “In term newborns, however, using infection rate as an endpoint is problematic given the sample size needed.”
The researchers said their study was potentially limited by lack of a control group and population selection, and described mothers in their center as “mostly well-informed and well-monitored during their pregnancy.”
The authors reported no relevant conflicts of interest.
SOURCE: El Helali N et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003057.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point:
Major finding: The rate of early-onset disease group B Streptococcus decreased from 1.01/1,000 cases to 0.21/1,000 cases across the antenatal and intrapartum periods.
Study details: A single-center study of antenatal culture screening for 11,226 deliveries during 2006-2009 and intrapartum PCR screening for 18,835 deliveries during 2010-2015.
Disclosures: The authors reported no relevant conflicts of interest.
Source: El Helali N et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003057.
