Long-term outcomes after repeat doses of antenatal corticosteroids.

Abstract

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].).

• Authors: Ronald J Wapner, Yoram Sorokin, Lisa Mele, Francee Johnson, Donald J Dudley, Catherine Y Spong, Alan M Peaceman, Kenneth J Leveno, Fergal Malone, Steve N Caritis, Brian Mercer, Margaret Harper, Dwight J Rouse, John M Thorp, Susan Ramin, Marshall W Carpenter, Steven G Gabbe, National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network
• Journal: The New England journal of medicine (N Engl J Med) Vol. 357 Issue 12 Pg. 1190-8 (Sep 20 2007) ISSN: 1533-4406 [Electronic] United States
• PMID: 17881751 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: Copyright 2007 Massachusetts Medical Society.

Chemical References

• Glucocorticoids
• Betamethasone

Topics

• Adult
• Betamethasone (administration & dosage, adverse effects)
• Body Size (drug effects)
• Cerebral Palsy (epidemiology)
• Child Development (drug effects)
• Child, Preschool
• Female
• Follow-Up Studies
• Glucocorticoids (administration & dosage, adverse effects)
• Health Status
• Humans
• Male
• Pregnancy
• Prenatal Care