Randomized placebo-controlled trial of a 42-day tapering course of dexamethasone to reduce the duration of ventilator dependency in very low birth weight infants: Outcome of study participants at 1-year adjusted age

Objective. Ventilator-dependent preterm infants are often treated with a pr olonged tapering course of dexamethasone to decrease the risk and severity of chronic lung disease. The objective of this study was to assess the effe ct of this therapy on developmental outcome at 1 year of age. Methods. Study participants were 118 very low birth weight infants who, at 15 to 25 days of life, were not weaning from assisted ventilation and were then enrolled in a randomized, placebo-controled, double-blind trial of a 4 2-day tapering course of dexamethasone. Infants were examined at 1 year of age, adjusted for prematurity, by a pediatrician and a child psychologist. A physical and neurologic examination was performed, and the Bayley Scales of Infant Development were administered. All examiners were blind to treatm ent group. Results. Groups were similar in terms of birth weight, gestational age, gen der, and race. A higher percentage of dexamethasone recipients had major in tracranial abnormalities diagnosed by ultrasonography (21% vs 11%). Group d ifferences were not found for Bayley Mental Development Index (median [rang e] for dexamethasone-treated group, 94 [50-123]; for placebo group, 90 [28- 117]) or Psychomotor Development Index Index (median [range]) for dexametha sone-treated group, 78 (50-109); for placebo-treated group, 81 [28-117]). M ore dexamethasone-treated infants had cerebral palsy (25% vs 7%) and abnorm al neurologic examination findings (45% vs 16%). In stratified analyses, ad justed for major cranial ultrasound abnormalities, these associations persi sted (OR values for cerebral palsy, 5.3; 95% CI: 1.3-21.4; OR values for ne urologic abnormality 3.6; 95% CI: 1.2-11.0). Conclusions. A 42-day tapering course of dexamethasone was associated with an increased risk of cerebral palsy. Possible explanations include an adver se effect of this therapy on brain development and/or improved survival of infants who either already have neurologic injury or who are at increased r isk for such injury.