Randomized trial of artificial surfactant (ALEC) given at birth to babies from 23 to 34 weeks gestation.

Artificial surfactant (ALEC) composed of dipalmitoylphosphatidylcholine and unsaturated phosphatidylglycerol in a ratio of 7:3 (w/w) and a dose of 50-100 mg was suspended in 1 ml of cold saline and used at birth as a prophylaxis against the respiratory distress syndrome and its complications in a two centre randomized prospective trial involving 341 babies from 23 to 34 weeks gestation regardless of their antenatal problems. The surfactant had little effect in babies above 29 weeks gestation and was most beneficial in babies under 30 weeks gestation (67 controls and 69 surfactant treated babies). In this subgroup the artificial surfactant significantly reduced the inspired oxygen and peak ventilator pressure requirements during the first 96 h, the incidence of intraventricular haemorrhages from 40% to 19% (P less than 0.01), the overall mortality from 36% to 17% (P less than 0.02), the mortality due to RDS from 31% to 9% (P less than 0.01), the need for more than 28 days oxygen from 37% to 21% (P = 0.05) and the use of pancuronium in ventilated babies from 52% to 27% (P less than 0.01). There were no apparent side effects. This protein free, artificial surfactant should be a useful addition to the therapy of babies under 30 weeks gestation to reduce the severity of their RDS and the incidence of serious complications.