Early or selective surfactant (colfosceril palmitate, Exosurf) for intubated babies at 26 to 29 weeks gestation. A European double-blind trial with sequential analysis. European Exosurf Study Group

Abstract

Objective: To compare a policy of giving surfactant to all intubated babies of gestational age 26 to 29 weeks with a policy of treating only those babies developing respiratory distress syndrome (RDS).

Design: Randomized, double-blind, placebo-controlled.

Setting: Twenty-two neonatal intensive care units in 5 countries.

Interventions: Blinded administration of either surfactant (colfosceril palmitate, Exosurf) or air placebo, within 2 hours of birth. Babies in either group developing RDS during the following 18 hours received 2 unblinded doses of surfactant 12 hours apart. Babies without RDS received a 2nd dose of surfactant or air as originally randomized 18 hours after the 1st dose.

Outcome measures: Primary: survival to 28 days without brain damage (cysts or hydrocephalus-blinded ultrasound assessment with central review). Secondary: incidence of RDS; durations of intubation, intensive care, and oxygen therapy.

Safety: incidences of pneumothorax, pulmonary interstitial emphysema, persistent ductus arteriosus, infection, and necrotizing enterocolitis.

Results: Two hundred twelve babies randomized to early and 208 to selective surfactant. One hundred five early babies and 142 selective babies developed RDS requiring unblinded surfactant (50% versus 68%; 95% CI of difference, 9% to 27%). At age 28 days, 175 early and 163 selective babies survived (83% versus 78%, 95% CI, -3% to 12%), 140 early and 131 selective without brain damage (66% versus 63%, 95% CI, -6% to 12%, P = 0.41). Significant reductions were seen in the incidence of pneumothorax (18% early versus 26% selective) and pulmonary interstitial emphysema (14% versus 22%) (95% CI for both, 1% to 16%).

Conclusions: Early surfactant reduces short-term morbidity, but any difference in outcome at 28 days is likely to be small.