Abstract
ABSTRACT: Bronchopulmonary dysplasia is an important complication of ventilation in babies for which treatment with steroids has been advocated. We report the results of a phase I study of early i.v. dexamethasone to prevent the development of bronchopulmonary dysplasia in a high-risk population of ventilated premature babies, < 30 wk gestation, with surfactant-treated respiratory distress syndrome. This study used a limited dexamethasone dosing regimen to minimize toxicity but used administration early in the course of acute lung disease to interrupt the injury cycle. Forty babies were enrolled; 19 were randomized to receive dexamethasone (0.5 mg/kg birth weight at 12–18 h of age and a second dose 12 h later) and 21 were randomized to receive placebo (i.v. saline). The dexamethasone group required less ventilatory support (mean airway, peak in-spiratory and end expiratory pressures, and intermittent mandatory ventilation) and supplemental oxygen after study d 4 (all p < 0.05, repeated measures analysis of variance). Improved tidal volume in the dexamethasone group, as measured by pulmonary function testing of infants who remained intubated, was seen on study d 7 (p = 0.02, t test). The dexamethasone group required shorter hospitalizations (median of 95 d versus 106 d, p = 0.01) (proportional hazards regression). Survival in the dexa methasone group was 89% versus 67% in the placebo group (p = 0.08, x2 analysis). Survival without bronchopulmonary dysplasia, diagnosed at 36 wk corrected gestational age, was 68% in the dexamethasone group versus 43% in the placebo group (p = 0.14). Mean blood pressure was elevated on study d 4 through 7 in the dexamethasone group, but this difference resolved by study d 10 without pharmacologic intervention. No differences in hyperglycemia, incidence of intraventricular hemorrhage (or its severity), or days to regain birth weight were seen. Early administration of dexamethasone resulted in short-term and suggested long-term benefits without significant complications. The results of this trial justify a large scale, broader-based (phase II) trial in premature babies with respiratory distress syndrome to determine the limits of effectiveness and the incidence of less-frequent potential side effects.
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Sanders, R., Cox, C., Phelps, D. et al. Two Doses of Early Intravenous Dexamethasone for the Prevention of Bronchopulmonary Dysplasia in Babies with Respiratory Distress Syndrome. Pediatr Res 36 (Suppl 1), 122–128 (1994). https://doi.org/10.1203/00006450-199407001-00022
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DOI: https://doi.org/10.1203/00006450-199407001-00022
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