CLINICAL TRIAL
JOURNAL ARTICLE
REVIEW
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Exogenous surfactant use in neonates.

OBJECTIVE: To review exogenous surfactant use in the treatment of respiratory distress syndrome (RDS) in premature neonates.

DATA SOURCES: A MEDLINE search and extensive review of journals was conducted to identify the information for this review from 1983 to 1995 using the following key words: prematurity, surfactant, clinical trials, beractant, Survanta, colfosceril, Exosurf, and neonatal respiratory distress syndrome.

STUDY SELECTION AND DATA EXTRACTION: All articles were considered for possible inclusion in the review. Emphasis was placed on controlled studies involving beractant and colfosceril palmitate.

DATA SYNTHESIS: Results of published clinical trials using beractant or colfosceril palmitate in premature infants at risk for RDS have shown improvement in the need for supplemental oxygen and ventilatory support over the course of RDS and a reduction in pneumothorax. However, there was little impact on the incidence of intraventricular hemorrhage. Clinical trials studying the treatment of established RDS have also shown similar improvements. In a comparison of prophylactic versus late treatment, no distinct advantage of preventive treatment was found, except among infants less than 26-28 weeks gestation. Single versus multiple-dose studies have shown no specific advantage of more than two doses of colfosceril palmitate. A comparison trial of beractant and colfosceril palmitate has shown no difference in outcome. Long-term follow-up studies have been encouraging among infants being treated with exogenous surfactant.

CONCLUSIONS: The use of beractant and colfosceril palmitate in premature infants has clearly decreased morbidity and mortality associated with RDS. Only one trial has compared the efficacy of beractant with that of colfosceril in the treatment of RDS. There does not appear to be a distinct advantage of one product over another. Early treatment of infants at highest risk for RDS, those less than 26-28 weeks gestation, seems to be beneficial over waiting for RDS to progress in severity. Further research needs to be performed to determine the optimal dosing and timing of these agents, as well as comparative trials studying efficacy. Criteria for use of these products need to be further defined to decrease the incidence of unnecessary treatment.

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