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Early treatment of respiratory distress syndrome with bovine surfactant in very preterm infants: A multicenter controlled clinical trial
Author(s) -
Gortner L.,
Bartmann P.,
Pohlandt F.,
Bernsau U.,
Porz F.,
Hellwege H. H.,
Seitz R. C.,
Hieronimi G.,
Bremer C.,
Jorch G.,
Hentschel R.,
Reiter H. L.,
Wolf H.,
Ball F.
Publication year - 1992
Publication title -
pediatric pulmonology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.866
H-Index - 106
eISSN - 1099-0496
pISSN - 8755-6863
DOI - 10.1002/ppul.1950140103
Subject(s) - medicine , bronchopulmonary dysplasia , respiratory distress , gestational age , pulmonary surfactant , surfactant therapy , birth weight , ductus arteriosus , pediatrics , low birth weight , neonatal respiratory distress syndrome , multicenter trial , neonatal intensive care unit , incidence (geometry) , anesthesia , randomized controlled trial , multicenter study , pregnancy , genetics , physics , optics , biology , thermodynamics
To determine the effect of bovine surfactant (SF‐RI 1, Alveofact) administered during the first hour following birth to very premature infants [gestational age (GA). 25‐30 weeks] in a multicenter, controlled trial. Hypothesis : Survival without bronchopulmonary dysplasia (BPD; definition: ventilator dependency or FiO 2 > 0.3 during spontaneous respiration) at day 28 is increased in surfactant‐treated infants (sequential analysis). Patients and methods : Thirty‐four infants [GA 28.0 ± 1.5 SD weeks, birth weight (BW), 1,048 ± 299 g] received 50 mg/kg BW surfactant, whereas 35 infants (GA, 27.6 ± 1.5 weeks, BW 969 ± 269 g) served as controls. Retreatment with surfactant (up to three identical doses) 12‐24 hours after the previous dose was permitted if FiO 2 was > 0.5. Results : Survival without BPD was significantly higher in surfactant treated infants (26/34) compared to controls (14/35; P=0.003). but in the incidence of pulmonary air leaks, patent ductus arteriosus, intracranial hemorrhage, and nosocomial infections they were not different. Conclusion : Bovine surfactant treatment improves survival without BPD in very premature infants at risk for neonatal respiratory distress syndrome (RDS). © 1992 Wiley‐Liss, Inc.