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Background Previous trials have shown that repeat courses of antenatal corticosteroids improve some neonatal outcomes in preterm infants but reduce birth weight and increase the risk of intrauterine growth restriction. We report long-term follow-up results of children enrolled in a randomized trial comparing single and repeat courses of antenatal corticosteroids.
Methods Women at 23 through 31 weeks of gestation who remained pregnant 7 days after an initial course of corticosteroids were randomly assigned to weekly courses of betamethasone, consisting of 12 mg given intramuscularly and repeated once at 24 hours, or an identical-appearing placebo. We studied the children who were born after these treatments when they were between 2 and 3 years of corrected age. Prespecified outcomes included scores on the Bayley Scales of Infant Development, anthropometric measurements, and the presence of cerebral palsy.
Results A total of 556 infants were available for follow-up; 486 children (87.4%) underwent physical examination and 465 (83.6%) underwent Bayley testing at a mean (±SD) corrected age of 29.3±4.6 months. There were no significant differences in Bayley results or anthropometric measurements. Six children (2.9% of pregnancies) in the repeat-corticosteroid group had cerebral palsy as compared with one child (0.5% of pregnancies) in the placebo group (relative risk, 5.7; 95% confidence interval, 0.7 to 46.7; P=0.12).
Conclusions Children who had been exposed to repeat as compared with single courses of antenatal corticosteroids did not differ significantly in physical or neurocognitive measures. Although the difference was not statistically significant, the higher rate of cerebral palsy among children who had been exposed to repeat doses of corticosteroids is of concern and warrants further study. (ClinicalTrials.gov number, NCT00015002
[ClinicalTrials.gov]
.)
Source Information
From Columbia University, New York (R.J.W., F.M.); Drexel University, Philadelphia (R.J.W.); Wayne State University, Detroit (Y.S.); George Washington University Biostatistics Center, Washington, DC (L.M.); Ohio State University, Columbus (F.J.); University of Utah, Salt Lake City (D.J.D.); National Institute of Child Health and Human Development, Bethesda, MD (C.Y.S.); Northwestern University, Chicago (A.M.P.); University of Texas Southwestern Medical Center, Dallas (K.J.L.); University of Pittsburgh Magee–Womens Hospital, Pittsburgh (S.N.C.); Case Western Reserve University, Cleveland (B.M.); Wake Forest University School of Medicine, Winston-Salem, NC (M.H.); University of Alabama, Birmingham (D.J.R.); University of North Carolina, Chapel Hill (J.M.T.); University of Texas, Houston (S.R.); Brown University, Providence, RI (M.W.C.); and Vanderbilt University, Nashville (S.G.G.).
Address reprint requests to Dr. Wapner at the Department of Obstetrics and Gynecology, Columbia University Medical Center, 622W 168th St., PH 16-66, New York, NY 10032.
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