Prophylaxis of respiratory distress syndrome by treatment with modified porcine surfactant at birth: a multicentre prospective randomized trial

G Bevilacqua, S Parmigiani, B Robertson, G Caramia, P Catalani, F Chiappe, G Rinaldi, R Magaldi, F Pantarotto, G Spennati, S Calo', Gs Perotti, L Galoni, G Compagnoni, E Corbella, V Tripodi, S Garano, N Cassata, G Sulliotti, L GambiniP Gancia, P Serrao, A Nicolo', G Bonacini, Costantino Romagnoli, Mt Gandolfo, G De Nisi, A Mazza, F Uxa

Risultato della ricerca: Contributo in rivistaArticolo in rivista

53 Citazioni (Scopus)


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.
Lingua originaleEnglish
pagine (da-a)609-620
Numero di pagine12
RivistaJournal of Perinatal Medicine
Stato di pubblicazionePubblicato - 1996
Pubblicato esternamente


  • Biological Agents
  • Birth Weight
  • Gestational Age
  • Humans
  • Infant, Newborn
  • Italy
  • Phospholipids
  • Prospective Studies
  • Pulmonary Surfactants
  • Regression Analysis
  • Respiratory Distress Syndrome, Newborn


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