The objective of this prospective, multicentre trial, carried out at 18 third level hospitals in Italy, was to evaluate efficacy of modified porcine
surfactant (
Curosurf), administered at birth to prevent the development of
respiratory distress syndrome (RDS) in premature infants. 287 babies with a gestational age of 24-30 weeks were randomized to prophylactic treatment with
Curosurf (80 mg/ml; dose 20 mg/kg) or to a control group receiving no
surfactant treatment in the delivery-room. Babies in both groups were eligible for rescue treatment with
surfactant (200 mg/kg) if they developed clinical symptoms of RDS and required
mechanical ventilation. The main end-point was to obtain, in the prophylaxis group, a 30% reduction in the incidence of grade 3-4 RDS. Median gestational age was 28 weeks in both groups and mean
birth weight 1010 and 1002 g, respectively for prophylaxis and control babies. There was a 32% reduction in the incidence of grade 3-4 RDS in the prophylaxis group (p < 0.05). This was associated with a significant reduction in mean maximum fraction of inspired
oxygen (0.57 vs 0.66%; p < 0.01), a decreased incidence of
pulmonary interstitial emphysema (7 vs 14%; p < 0.05) and a lowered mortality (21 vs 35%; p < 0.01). Combined unfavourable outcome (mortality +
bronchopulmonary dysplasia and/or grade 3-4 intraventricular
hemorrhage and/or grade 2-4
retinopathy of prematurity) was significantly lower in the prophylaxis than in the second group (41 vs 58%; p < 0.01). The favourable effects of prophylactic treatment were equally recorded in all the age groups, including the babies with the lowest gestational age (24-25 weeks). Multiple and logistic regression analysis confirmed that high gestational age and
surfactant prophylaxis were, independently, associated with a lower degree of RDS (p = 0.0001 and p = 0.0008, respectively) and a lower mortality (p = 0.0001 and p = 0.0045, respectively). We conclude that prophylaxis with modified natural
surfactant effectively prevents RDS in newborn babies between 24 and 30 weeks' gestation.