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.

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.