Title | Association of Antenatal Corticosteroids and Magnesium Sulfate Therapy With Neurodevelopmental Outcome in Extremely Preterm Children. |
Publication Type | Journal Article |
Year of Publication | 2020 |
Authors | Gentle SJ, Carlo WA, Tan S, Gargano M, Ambalavanan N, Chawla S, Bell EF, Bann CM, Hintz SR, Heyne RJ, Tita A, Higgins RD |
Corporate Authors | Eunice Kennedy Shriver National Institute of Child Health and Human Development(NICHD) Neonatal Research Network |
Journal | Obstet Gynecol |
Volume | 135 |
Issue | 6 |
Pagination | 1377-1386 |
Date Published | 2020 06 |
ISSN | 1873-233X |
Keywords | Adrenal Cortex Hormones, Child, Preschool, Databases, Factual, Female, Gestational Age, Humans, Infant, Infant Mortality, Infant, Extremely Premature, Infant, Newborn, Logistic Models, Magnesium Sulfate, Male, Neurodevelopmental Disorders, Pregnancy, Pregnancy Outcome, Prenatal Care, Prenatal Exposure Delayed Effects, Prospective Studies, United States |
Abstract | OBJECTIVE: To test the primary hypothesis that extremely preterm children antenatally exposed to both magnesium sulfate and antenatal corticosteroids have a lower rate of severe neurodevelopmental impairment or death compared with those exposed to antenatal corticosteroids alone. METHODS: This was a prospective observational study of children born at 22 0/7-26 6/7 weeks of gestation from 2011 to 2014 at Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network hospitals (N=3,093). The primary outcome was severe neurodevelopmental impairment or death at 18-26 months of corrected age follow-up based on exposure to antenatal corticosteroids and magnesium sulfate or antenatal corticosteroids alone. Secondary outcomes included components of severe neurodevelopmental impairment by exposure group and comparisons of severe neurodevelopmental impairment or death between children exposed to both antenatal corticosteroids and magnesium sulfate with those exposed to magnesium sulfate alone or to neither antenatal corticosteroids nor magnesium sulfate. Logistic regression models adjusted for background characteristics. RESULTS: Children exposed to both antenatal corticosteroids and magnesium sulfate had a lower rate of severe neurodevelopmental impairment or death (813/2,239, 36.3%) compared with those exposed to antenatal corticosteroids alone (225/508, 44.3%; adjusted odds ratio [aOR] 0.73; 95% CI 0.58-0.91), magnesium sulfate alone (47/89, 53%; aOR 0.49; 95% CI 0.29-0.82), or neither therapy (121/251; 48.2%; aOR 0.66, 95% CI 0.49-0.89). Similarly, children exposed to both antenatal corticosteroids and magnesium sulfate had a lower rate of death compared with either or neither therapy, but the rate of severe neurodevelopmental impairment among survivors did not differ between exposure groups. CONCLUSION: In children born between 22 0/7 and 26 6/7 weeks of gestation, exposure to both antenatal corticosteroids and magnesium sulfate was associated with lower rates of severe neurodevelopmental impairment or death and death compared with exposure to antenatal corticosteroids alone. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT00063063. |
DOI | 10.1097/AOG.0000000000003882 |
Alternate Journal | Obstet Gynecol |
PubMed ID | 32459430 |
PubMed Central ID | PMC7278037 |
Grant List | UG1 HD068263 / HD / NICHD NIH HHS / United States U10 HD021373 / HD / NICHD NIH HHS / United States UG1 HD087226 / HD / NICHD NIH HHS / United States UG1 HD068270 / HD / NICHD NIH HHS / United States UG1 HD053089 / HD / NICHD NIH HHS / United States UG1 HD034216 / HD / NICHD NIH HHS / United States UG1 HD027904 / HD / NICHD NIH HHS / United States UG1 HD027880 / HD / NICHD NIH HHS / United States UG1 HD053109 / HD / NICHD NIH HHS / United States UG1 HD027851 / HD / NICHD NIH HHS / United States UG1 HD068244 / HD / NICHD NIH HHS / United States UG1 HD027853 / HD / NICHD NIH HHS / United States UG1 HD087229 / HD / NICHD NIH HHS / United States UG1 HD040689 / HD / NICHD NIH HHS / United States UG1 HD068284 / HD / NICHD NIH HHS / United States UG1 HD021385 / HD / NICHD NIH HHS / United States UG1 HD040492 / HD / NICHD NIH HHS / United States UG1 HD021364 / HD / NICHD NIH HHS / United States UG1 HD068278 / HD / NICHD NIH HHS / United States U24 HD095254 / HD / NICHD NIH HHS / United States |