A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome

OBJECTIVE: To compare the efficacy and safety of two surfactant preparations in the treatment of respiratory distress syndrome (RDS). METHODS: We conducted a randomized, masked comparison trial at 21 centers. Infants with RDS who were undergoing mechanical ventilation were eligible for treatment wit...

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Published in:	The Journal of pediatrics Vol. 128; no. 3; pp. 396 - 406
Main Authors:	Hudak, Mark L., Farrell, Elaine E., Rosenberg, Adam A., Jung, August L., Auten, Richard L., Durand, David J., Horgan, Michael J., Buckwald, Sharon, Belcastro, Marc R., Donohue, Pamela K., Carrion, Vivien, Maniscalco, William W., Balsan, Michael J., Torres, Benjamin A., Miller, Randy R., Jansen, Robert D., Graeber, Janet E., Laskay, Kathleen M., Matteson, Elizabeth J., Egan, Edmund A., Brody, Alan S., Martin, David J., Riddlesberger, Merchline M., Montgomery, Paul
Format:	Journal Article
Language:	English
Published:	New York, NY Mosby, Inc 01-03-1996 Elsevier
Subjects:	Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Biological and medical sciences Bronchopulmonary Dysplasia - epidemiology Cross-Over Studies Drug Combinations Emergency and intensive care: neonates and children. Prematurity. Sudden death Fatty Alcohols - therapeutic use Humans Incidence Infant, Newborn Intensive care medicine Length of Stay Linear Models Medical sciences Phosphorylcholine Pneumothorax - epidemiology Polyethylene Glycols - therapeutic use Pulmonary Emphysema - epidemiology Pulmonary Surfactants - therapeutic use Respiration, Artificial Respiratory Distress Syndrome, Newborn - mortality Respiratory Distress Syndrome, Newborn - therapy Survival Rate Time Factors Treatment Outcome RDS BPD a/A P O 2 CLD F IO 2 IVH MAP Human Respiratory disease Multicenter study Animal origin Artificial ventilation Chemotherapy Newborn Synthetic product Treatment Pulmonary surfactant Double blind study Respiratory distress Comparative study
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Summary:	OBJECTIVE: To compare the efficacy and safety of two surfactant preparations in the treatment of respiratory distress syndrome (RDS). METHODS: We conducted a randomized, masked comparison trial at 21 centers. Infants with RDS who were undergoing mechanical ventilation were eligible for treatment with two doses of either a synthetic (Exosurf) or natural (Infasurf) surfactant if the ratio of arterial to alveolar partial pressure of oxygen was less than or equal to 0.22. Crossover treatment was allowed within 96 hours of age if severe respiratory failure (defined as two consecutive arterial/alveolar oxygen tension ratios ≤0.10) persisted after two doses of the randomly assigned surfactant. Four primary outcome measures of efficacy (the incidence of pulmonary air leak [≤7 days]; the severity of RDS; the incidence of death from RDS; and the incidence of survival without bronchopulmonary dysplasia [BPD] at 28 days after birth) were compared by means of linear regression techniques. RESULTS: The primary analysis of efficacy was performed in 1033 eligible infants and an analysis of safety outcomes in the 1126 infants who received study surfactant. Preentry demographic characteristics and respiratory status were similar for the two treatment groups, except for a small but significant difference in mean gestational age (0.5 week) that favored the Infasurf treatment group. Pulmonary air leak (≤7 days) occurred in 21% of Exosurf- and 11% of Infasurf-treated infants (adjusted relative risk, 0.53; 95% confidence interval, 0.40 to 0.71; p ≤0.0001). During the 72 hours after the initial surfactant treatment, the average fraction of inspired oxygen (±SEM) was 0.47 ± 0.01 for Exosurf- and 0.39 ± 0.01 for Infasurf-treated infants (difference, 0.08; 95% confidence interval, 0.06 to 0.10; p <0.0001); the average mean airway pressure (±SEM) was 8.6 ± 0.1 cm H 2O for Exosurf- and 7.2 ± 0.1 cm H 2O for Infasurf-treated infants (difference, 1.4 cm H 2O; 95% confidence interval, 1.0 to 1.8 cm H 2O; p <0.0001). The incidences of RDS-related death, total respiratory death, death to discharge, and survival without bronchopulmonary dysplasia at 28 days after birth did not differ. The number of days of more than 30% inspired oxygen and of assisted ventilation, but not the duration of hospitalization, were significantly lower in Infasurf-treated infants. CONCLUSION: Compared with Exosurf, Infasurf provided more effective therapy for RDS as assessed by significant reductions in the severity of respiratory disease and in the incidence of air leak complications. (J P EDIATR 1996;128:396-406)
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ISSN:	0022-3476 1097-6833
DOI:	10.1016/S0022-3476(96)70291-3