Ten centre trial of artificial surfactant (artificial lung expanding compound) in very premature babies. Ten Centre Study Group.

A protein free artificial surfactant (artificial lung expanding compound; ALEC) composed of dipalmitoylphosphatidylcholine and phosphatidylglycerol was assessed for its effect on the main complications of prematurity in a prospective two stage randomised trial of 328 unselected babies delivered at between 25 and 29 weeks of gestation. Babies were randomised to receive approximately 100 mg artificial surfactant suspension or 1 ml saline. This was given at birth into the pharynx with up to three more endotracheal doses if the baby was intubated during the first day. Treatment with artificial surfactant reduced the neonatal mortality from 27% to 14%, the incidence of parenchymal brain haemorrhages from 24% to 16%, and the severity of the respiratory distress syndrome. In the first 10 days babies treated with artificial surfactant who survived averaged 19 hours less in greater than 30% oxygen, 20 hours less ventilation, and 17 hours less supplemental oxygen. Artificial surfactant had no effect on the incidence of pneumothoraces, pulmonary interstitial emphysema, patent ductus arteriosus, or postnatal infections and no serious side effects. Artificial surfactant (ALEC) given to very premature babies at birth significantly reduces their mortality and the respiratory support needed and should prove a valuable addition to treatment.

RCT Entities:   Population Interventions Outcomes