Exogenous surfactant for treatment of respiratory distress syndrome in premature infants.

A prospective, randomized and controlled trial was conducted to evaluate the efficacy and safety of surfactant in the treatment of respiratory distress syndrome (RDS) in infants. Eighteen premature infants with RDS were studied. Group I consisted of 9 premature infants with a mean birth weight of 1,455 +/- 265.9 g and a mean gestational age of 31.4 +/- 1.3 weeks. Group II consisted of 9 premature infants with a mean birth weight of 1,411 +/- 379.0 g and a mean gestational age of 30.6 +/- 1.7 weeks. Reconstituted bovine surfactant (Surfactant TA, Tokyo Tanabe Co., Japan), 120 mg/kg body weight was suspended in 4 ml normal saline and delivered to the lungs of the patients in group I through an endotracheal tube via a catheter in five divided doses (mean age at this point was 5.7 +/- 4.5 hours). An air placebo (4 ml per kilogram) was given to the patients in group II. The results showed that significant improvement in oxygenation, characterized by (1) an increase in the ratio of arterial to alveolar oxygen tension; (2) a decrease in the fractional inspiratory oxygen concentration; and (3) changes in mean airway pressure and ventilatory index, were noted in the surfactant-treated group. Pneumothorax was found in one surfactant-treated infant and one control infant. Pulmonary interstitial emphysema was found in one control infant. One control infant later developed bronchopulmonary dysplasia. Four (44.4%) of the surfactant-treated infants and four (44.4%) of the control infants had evidence of patient ductus arteriosus. The mean duration from birth to extubation in the surfactant-treated infants was 121.9 +/- 1.9 hours.