Use of surfactant for prevention of respiratory distress syndrome in newborn infants in spontaneous breathing. A randomized multicentre clinical pilot-study.

Abstract

Objective: To evaluate the impact of administration of surfactant to premature infants in the delivery-room on respiratory distress syndrome (RDS) and short-term (28 days) mortality and outcome in a developing country where mechanical ventilators for infants were not available at the time of the study and neonatal mortality rate is extremely high.

Design: Babies with gestational age 28-33 wks were randomly assigned to receive porcine surfactant prophylaxis (200 mg/kg endotracheally) in the delivery-room or routine assistance in 4 hospitals in Romania. After randomization, supplemental oxygen and continuous airway positive pressure were allowed if available. No rescue treatment was allowed. Diagnosis of RDS was done by means of Silverman score > or = 3 within 24 hrs + requirement of supplemental oxygen > or = 40%. Other examinations were performed depending on local availability.

Results: 53 babies were analyzed, and 28 were given prophylaxis while 25 resulted controls. The two groups did not differ for gestational age and birth weight (mean values for prophylaxis and control infants respectively: 30.6 +/- 1.6 vs 30.2 +/- 1.7 wks and 1457 +/- 258 vs 1397 +/- 388 g.), nor for sex, type of delivery and Apgar score. Mortality 0-28 days was 42.8 vs 48% in the prophylaxis vs control group (p = ns), due prevalently to intracerebral haemorrhage in both groups. Babies given surfactant tended to die later than controls. The Silverman score resulted significantly reduced in the first 24 hours in the babies given prophylaxis vs the controls (p < 0.05) and values of PaO2/FiO2 ratio were almost constantly higher in the babies that received surfactant compared to the control infants during the first three days of life, even if the differences were not significant.

Conclusion: Our data confirm that prophylaxis of RDS with surfactant in the delivery-room is able to improve the clinical conditions of the babies, however without the complete support of neonatal intensive care it does not resolve the problem of survival and unfavourable outcome in the babies with the lowest gestational ages. This kind of approach might anyhow facilitate the transport of the baby from a peripheral delivery-room to few equipped neonatal intensive care units to be created.