Exogenous human surfactant for treatment of severe respiratory distress syndrome: A randomized prospective clinical trial*

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We performed a randomized, prospective clinical trial comparing intratracheal administration of human surfactant with conventional treatment with intermittent mandatory mechanical ventilation alone for treatment of severe respiratory distress syndrome in preterm infants of <30 weeks gestation. Twenty-two infants (mean gestational age 27.0 weeks, mean birth weight 987 gm) were given surfactant, and 23 infants (mean gestational age 27.2 week, mean birth weight 1055 gm) received intermittent mandatory ventilation. Infants given surfactant required less FiO2 during the first week, had lower mean airway pressure during the first 48 hours, and had improved ventilatory index and a/A Po2 ratio. Death or the occurrence of bronchopulmonary dysplasia was significantly less among infants given surfactant (P=0.019). Pneumothorax, pulmonary interstitial emphysema, and need for Fio2≥0.3 for >30 days was significantly less in the surfactant group. This trial confirms the efficacy of treatment with human surfactant in preterm infants with severe respiratory distress syndrome.

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Supported by Grants HD-16292 (T.A.M.) and HD-10622 (L.G.) from the National Institute of Child Health and Human Development, by a Clinical Research Grant from the March of Dimes/Birth Defects Foundation (T.A.M.), by the Finnish Academy, and by the Sigrid Juselius Foundation (M.H.). Presented in part at a meeting of the Society for Pediatric Research, San Francisco, May 1984.

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