Previous studies using scheduled repetitive courses of ACS have demonstrated limited benefit and concern over potential risk. We present the first study evaluating the impact of a single “rescue course” of ACS on neonatal outcome.
A multi-center, randomized, double blind, placebo controlled trial was performed. Eligible patients with singletons or twins were < 33 weeks (wks), had completed a single course of betamethasone before 30 wks and at least 14 days prior, and were judged to have a recurring threat of preterm delivery in the coming week. Patients were randomized to receive a single “rescue course” of ACS or placebo. Exclusion criteria included: PROM, advanced dilation (> 5 cm), chorioamnionitis, and other steroid use. The primary outcome was composite neonatal morbidity at < 34 wks.
437 patients were randomized (223 study group, 214 placebo group). 55% of patients in each group delivered at < 34 wks. The groups were similar in gestational age (GA) at randomization (29.4 wks) and at delivery (33.0 wks), proportion of twins, delivery route, delivery indications, APGAR scores, cord pH, birth weight, and head circumference. There was a significant reduction in composite neonatal morbidity < 34 wks in the “rescue steroid” group vs. placebo (42.5% vs. 63.3%, RR 0.67, 0.54.-0.83, p=0.0002) as well as significantly decreased RDS, ventilator support, and surfactant use. Perinatal mortality and other morbidities were similar in each group. When all 578 neonates were included in the analysis (regardless of GA at delivery), a significant reduction in composite morbidity in the “rescue steroid” group was still demonstrated (30.3% vs. 41.7%, RR 0.73, 0.58-0.91, P=.0055) as well improvement in other respiratory morbidities, but no other differences in outcome including head size and birth weight were evident.
Administration of a single “rescue course” of ACS before 33 wks improves neonatal outcome without apparent increased risk.
© 2008 Mosby, Inc. Published by Elsevier Inc. All rights reserved.