Early dexamethasone - Attempting to prevent chronic lung disease

Background. We previously demonstrated improved survival and early outcomes in a pilot trial of 2 doses of intravenous dexamethasone for infants with surfactant-treated respiratory distress syndrome.(1) A multicenter, randomi zed, double-blind trial was undertaken to confirm these results. Methods. Infants <30 weeks' gestation were eligible if they had respiratory distress syndrome, required mechanical ventilation at 12 to 18 hours of ag e, and had received at least 1 dose of exogenous surfactant. Infants were e xcluded if sepsis or pneumonia was suspected or if congenital heart disease or chromosomal abnormalities were present. A total of 384 infants were enr olled-189 randomized to dexamethasone (.5mg/kg birth weight at 12-18 hours of age and a second dose 12 hours later) and 195 to an equal volume of sali ne placebo. Results. No differences were found in the dexamethasone versus placebo grou ps, respectively, regarding the primary outcomes of survival (79% vs 83%), survival without oxygen at 36 weeks' corrected gestational age (CGA; both 5 9%), and survival without oxygen at 36 weeks' CGA and without late glucocor ticoid therapy (46% vs 44%). No significant differences between the groups in estimates from Kaplan-Meier survival analyses were found for median days on oxygen (50 vs 56 days), ventilation (20 vs 27 days), days to regain bir th weight (15.5 vs 14 days), or length of stay (LOS; 88 vs 89 days). Infant s given early dexamethasone were less likely to receive later glucocorticoi d therapy for bronchopulmonary dysplasia during their hospitalization (27% vs 35%). No clinically significant side effects were noted in the dexametha sone group, although there were transient elevations in blood glucose and b lood pressure followed by a return to baseline by study day 10. Among infan ts who died (40 vs 33), there were no differences in the median days on oxy gen, ventilation, nor LOS. However, in survivors (149 vs 162), the followin g were observed: median days on oxygen 37 versus 45 days, ventilation 14 ve rsus 19 days, and LOS 79 versus 81 days, for the dexamethasone versus place bo groups, respectively. Conclusions. This dose of early intravenous dexamethasone did not reduce th e requirement for oxygen at 36 weeks' CGA and survival was not improved. Ho wever, early dexamethasone reduced the use of later prolonged dexamethasone therapy, and among survivors, reduced the median days on oxygen and ventil ation. We conclude that this course of early dexamethasone probably represe nts a near minimum dose for instituting a prophylactic regimen against bron chopulmonary dysplasia.