Randomized clinical trial of surfactant prophylaxis in retinopathy of prematurity.

Prophylactic lung surfactant is commonly used to reduce the severity of neonatal respiratory distress syndrome in premature infants. There is disagreement in the literature regarding the effect of prophylactic lung surfactant on the incidence of retinopathy of prematurity (ROP). Sixty-four infants, gestational age 23 to 32 weeks, birth weight 610 to 1250 g, were randomized to receive either intratracheal bovine surfactant prophylaxis or air control, at our institution, as part of a national double-masked multicenter trial. Forty-eight of these infants survived and underwent complete ophthalmologic examinations by a single masked examiner. ROP data were gathered retrospectively. ROP developed in 19 of the 23 (83%) who received surfactant and 15 of the 25 (60%) controls (P = .1). Analysis of the worst stage of ROP for each infant also revealed no difference between the surfactant and control groups (P = .4). Our retrospective analysis of ROP data in a prospective double-masked randomized study revealed no significant effect of surfactant on the incidence or severity of ROP.