Cited by 819Neonatal Respiratory Health ResearchInfant Development and Preterm CarePreterm Birth and Chorioamnionitis

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Antenatal Betamethasone for Women at Risk for Late Preterm Delivery

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Gyamfi-Bannerman, Cynthia, Thom, Elizabeth A., Blackwell, Sean C., Tita, Alan T.N., Reddy, Uma M., Saade, George R., Rouse, Dwight J., McKenna, David S., Clark, Erin A.S., Thorp, John M., Chien, Edward K., Peaceman, Alan M., Gibbs, Ronald S., Swamy, Geeta K., Norton, Mary E., Casey, Brian M., Caritis, Steve N., Tolosa, Jorge E., Sorokin, Yoram, VanDorsten, J. Peter, Jain, Lucky·2016·New England Journal of Medicine

DOI 10.1056/nejmoa1516783PMC PMC4823164

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Abstract

BACKGROUND: Infants who are born at 34 to 36 weeks of gestation (late preterm) are at greater risk for adverse respiratory and other outcomes than those born at 37 weeks of gestation or later. It is not known whether betamethasone administered to women at risk for late preterm delivery decreases the risks of neonatal morbidities. METHODS: We conducted a multicenter, randomized trial involving women with a singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation who were at high risk for delivery during the late preterm period (up to 36 weeks 6 days). The participants were assigned to receive two injections of betamethasone or matching placebo 24 hours apart. The primary outcome was a neonatal composite of treatment in the first 72 hours (the use of continuous positive airway pressure or high-flow nasal cannula for at least 2 hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 hours, extracorporeal membrane oxygenation, or mechanical ventilation) or stillbirth or neonatal death within 72 hours after delivery. RESULTS: The primary outcome occurred in 165 of 1427 infants (11.6%) in the betamethasone group and 202 of 1400 (14.4%) in the placebo group (relative risk in the betamethasone group, 0.80; 95% confidence interval [CI], 0.66 to 0.97; P=0.02). Severe respiratory complications, transient tachypnea of the newborn, surfactant use, and bronchopulmonary dysplasia also occurred significantly less frequently in the betamethasone group. There were no significant between-group differences in the incidence of chorioamnionitis or neonatal sepsis. Neonatal hypoglycemia was more common in the betamethasone group than in the placebo group (24.0% vs. 15.0%; relative risk, 1.60; 95% CI, 1.37 to 1.87; P<0.001). CONCLUSIONS: Administration of betamethasone to women at risk for late preterm delivery significantly reduced the rate of neonatal respiratory complications. (Funded by the National Heart, Lung, and Blood Institute and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT01222247.).

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Authors: Gyamfi-Bannerman, C., Thom, E. A., Blackwell, S. C., Tita, A. T. N., Reddy, U. M., Saade, G. R., Rouse, D. J., McKenna, D. S., Clark, E. A. S., Thorp, J. M., Chien, E. K., Peaceman, A. M., Gibbs, R. S., Swamy, G. K., Norton, M. E., Casey, B. M., Caritis, S. N., Tolosa, J. E., Sorokin, Y., VanDorsten, J. P., & Jain, L.
Affiliations: From Columbia University, New York (C.G.-B.); the George Washington University Biostatistics Center, Washington, DC (E.A.T.); the University of Texas Health Science Center at Children’s Memorial Hermann Hospital, Houston (S.C.B.), the University of Texas Medical Branch, Galveston (G.R.S.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.) — all in Texas; the University of Alabama at Birmingham, Birmingham (A.T.N.T.); the Eunice Kennedy Shriver National Institute of Child Health and...
Memorial Hermann (US)
Northwestern University (US)
ORCID: Thom, Elizabeth A.
Blackwell, Sean C.
Tita, Alan T.N.
Reddy, Uma M.
Rouse, Dwight J.
McKenna, David S.
Clark, Erin A.S.
Thorp, John M.
Chien, Edward K.
Peaceman, Alan M.
Gibbs, Ronald S.
Swamy, Geeta K.
Norton, Mary E.
Casey, Brian M.
Caritis, Steve N.
Tolosa, Jorge E.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2016-04-07
Volume: 374
Issue: 14
Pages: 1311-1320
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1516783
PMC: PMC4823164
OpenAlex: W2321364247
Cited by: 814
References: 82
Citations by year: 2026: 59 · 2025: 69 · 2024: 67 · 2023: 69 · 2022: 98 · 2021: 92 · 2020: 81 · 2019: 90 · 2018: 69 · 2017: 68 · 2016: 48
FWCI: 81.34
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Institutes of Health (5ul1tr001067-05, UL1TR000040)
National Heart, Lung, and Blood Institute (R01HL098554, U01HL098554, R01HL098354, HL098554, HL098354, U01HL098354)
National Center for Advancing Translational Sciences (UL1-TR001067)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD68282, HD40512, HD53118, U01HD036801, HD27917, U10HD040544, U10HD034208, HD-27915, U10HD040512, HD34116, HD68268, UG1HD034116, HD40545, (HD40500, UG1HD053097, U10HD027915, HD68258, U10HD040545, U10HD040560, HD 40544, U10HD068268, HD40560, HD53097, U10HD027917, U10HD036801, U10HD021410, HD 34208, HD 36801, U10HD053097, U10HD034116, HD27869, UG1HD068282, [HD21410, UG1HD068258, U10HD040500, U10HD040485, U10HD053118, U10HD068282, U10HD027869, U10HD034136, UG1HD068268, U10HD068258, UG1HD034208, U24HD036801, UG1HD040500, UG1HD040512, UG1HD027869, UG1HD040544, UG1HD040485, UG1HD027915, UG1HD040560, UG1HD040545, HD 40485)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Neonatal Respiratory Health Research
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
Health Sciences › Medicine › Obstetrics and Gynecology › Preterm Birth and Chorioamnionitis
Keywords: betamethasone, antenatal corticosteroids, late preterm birth, neonatal respiratory distress, bronchopulmonary dysplasia, transient tachypnea of the newborn, neonatal hypoglycemia, neonatal sepsis, chorioamnionitis, neonatal mortality, surfactants
MeSH terms: Adult, Betamethasone, Bronchopulmonary Dysplasia, Female, Premature Rupture of Fetal Membranes, Gestational Age, Glucocorticoids, Humans, Hypoglycemia, Infant, Newborn, Infant, Premature, Infant, Premature, Diseases, Injections, Intramuscular, Obstetric Labor, Premature, Oxygen Inhalation Therapy, Pregnancy, Pregnancy Trimester, Third, Pulmonary Surfactants, Respiration, Artificial, Respiratory Tract Diseases

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Antenatal Betamethasone for Women at Risk for Late Preterm Delivery

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