Early intravenous dexamethasone (dex) for the prevention of BPD in surfactant treated babies with RDS. 1138

We previously demonstrated improved survival and early outcomes in a pilot trial of 2 doses of dex for babies with RDS (Pediatr Res 1994;36:122-128). A multicenter randomized double blind trial was undertaken to confirm these results. 384 babies < 30w gestation were enrolled - 189 randomized to dex(0.5mg/kg birth weight @ 12-18 h of age and a second dose 12h later) and 195 to an equal volume of saline placebo. No differences were found in the dex v placebo groups, respectively, regarding the primary outcomes of survival (79% v 83%), survival without O2 @ 36w corrected age (both 59%), and survival without O2 @ 36w corrected age & without late steroids(46% v 44%). No significant differences between the groups in estimates from Kaplan-Meier survival analyses were found for median days on O2(50 v 56d), ventilation (20 v 27d), days to regain birth weight (15.5 v 14d), nor length of stay (LOS)(88 v 89d). Babies given early dex were less likely to receive later steroids for BPD during their hospitalization (25% v 35%, p=0.042, χ²). No clinically significant side effects were noted in the dex group although there were transient elevations in blood glucose and blood pressure with a return to baseline by study day 10. In babies who died (40 v 33), there were no differences in the median days on O2, ventilation, nor LOS. However, in survivors (149 v 162), the following were observed: median days on O2 (37 v 45d; p=.016), ventilation (14 v 19d; p=.018) and LOS (79 v 81d; p=.212), for the dex v placebo groups, respectively. These results show that early dex reduced the need for later prolonged dex therapy (which has a higher likelihood of sequelae) and that early dex has a beneficial effect on babies who survive as reflected in the median days on O2 and ventilation. The use of later steroids for BPD probably reduced the magnitude of the differences between the groups on the primary outcomes. We conclude that this course of early dex represents a minimally effective prophylactic regimen and that finding the optimal dosing schedule merits further study.