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PEDIATRICS Vol. 105 No. 3 March 2000, pp. 542-548
Attempting To Prevent Chronic Lung Disease
Received Feb 16, 1999; accepted Jul 20, 1999.
,
,
From the Departments of Pediatrics (Neonatology) and
Biostatistics, * Children's Hospital at Strong, Rochester, New York;
Westchester Medical Center, Valhalla, New York; § Albany Medical
College, Albany, New York; Cape Fear Valley Medical Center,
Fayetteville, North Carolina.
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, randomized, 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 age, and had received at least 1 dose of exogenous surfactant. Infants were excluded if sepsis or pneumonia was suspected or if congenital heart disease or chromosomal abnormalities were present. A total of 384 infants were enrolled
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 saline placebo.
Results. No differences were found in the dexamethasone versus placebo groups, respectively, regarding the primary outcomes of survival (79% vs 83%), survival without oxygen at 36 weeks' corrected gestational age (CGA; both 59%), and survival without oxygen at 36 weeks' CGA and without late glucocorticoid 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 birth weight (15.5 vs 14 days), or length of stay (LOS; 88 vs 89 days). Infants given early dexamethasone were less likely to receive later glucocorticoid therapy for bronchopulmonary dysplasia during their hospitalization (27% vs 35%). No clinically significant side effects were noted in the dexamethasone group, although there were transient elevations in blood glucose and blood pressure followed by a return to baseline by study day 10. Among infants who died (40 vs 33), there were no differences in the median days on oxygen, ventilation, nor LOS. However, in survivors (149 vs 162), the following were observed: median days on oxygen 37 versus 45 days, ventilation 14 versus 19 days, and LOS 79 versus 81 days, for the dexamethasone versus placebo groups, respectively.
Conclusions. This dose of early intravenous dexamethasone did not reduce the requirement for oxygen at 36 weeks' CGA and survival was not improved. However, early dexamethasone reduced the use of later prolonged dexamethasone therapy, and among survivors, reduced the median days on oxygen and ventilation. We conclude that this course of early dexamethasone probably represents a near minimum dose for instituting a prophylactic regimen against bronchopulmonary dys- plasia. Key words: neonate, bronchopulmonary dysplasia, glucocorticoids, randomized clinical trials, respiratory distress syndrome.
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