Randomized Trial of 42-Day Compared with 9-Day Courses of Dexamethasone for the Treatment of Evolving Bronchopulmonary Dysplasia in Extremely Preterm Infants.

Abstract

To compare pulmonary and neurodevelopmental outcomes in extremely preterm infants with evolving bronchopulmonary dysplasia treated with either a 42-day course of dexamethasone or 9-day course(s) of dexamethasone. This was a prospective, randomized study in 59 infants ≤27 weeks of gestation born between October 2006 and December 2010, who at day 10-21 of life had ventilatory support with mean airway pressure ≥8 cm H₂O and FiO₂ ≥60%. Infants received dexamethasone 0.5 mg/k/day × 3 days followed by a slow taper (42-day group, n = 30) or dexamethasone 0.5 mg/k/day followed by a rapid taper (9-day group, n = 29). Infants in the 9-day group received additional 9-day courses if they again required entry support. The primary outcome was intact survival (normal neurologic examination, IQ >70, and functioning in school without supplemental educational support) at 7 years of age. The 42-day and 9-day groups were similar for mean gestational age (25 weeks) and all baseline characteristics. Nineteen of 29 infants (66%) in the 9-day group received only 1 course of dexamethasone; therefore, the total steroid dose for the 42-day group (7.56 mg/kg) was significantly greater than that for the 9-day group (4.04 mg/kg), P < .001. Infants in the 42-day group had shorter duration of ventilation (25 vs 37 days), P < .005, received fewer transfusions (2 vs 3.5), P < .01, and reached full enteral feeds earlier (40 vs 46 days), P < .05. Intact survival at school age was significantly increased in the 42-day group (75%) compared with the 9-day group (34%), P < .005. A 42-day tapering course of dexamethasone in extremely preterm infants at high risk for bronchopulmonary dysplasia decreased hospital morbidities and increased rate of survival without handicap compared with a treatment protocol that attempted to minimize steroid exposure.