One-year follow-up evaluation of 260 premature infants with respiratory distress syndrome and birth weights of 700 to 1350 grams randomized to two rescue doses of synthetic surfactant or air placebo

Alice Gong, Endla Anday, Stephen Boros, Richard Bucciarelli, David Burchfield, Janet Zucker, Walker Long

Research output: Contribution to journalArticle

19 Scopus citations

Abstract

A multicenter, randomized, double-blind, placebo-controlled trial of synthetic surfactant therapy for premature infants with respiratory distress syndrome (RDS) and birth weights of 700 to 1350 gm demonstrated a reduction in severity of RDS, morbidity, and neonatal and 1-year mortality. Of the 419 infants who were entered in the study, 80% of the surviving infants in both the air placebo group (122) and the synthetic surfactant group (138) returned for the follow-up evaluation at 1-year adjusted age. The only significant difference observed at follow-up was a reduction in the incidence of mild cerebral palsy in the synthetic surfactant group (air placebo group, 8 of 122 [7%]; synthetic surfactant group, 3 of 138 [2%]; relative risk 0.306; 95% confidence interval 0.094, 0.999). No differences were observed between the air placebo and synthetic surfactant treatment groups with respect to health status of the infants, including the incidence of retinopathy of prematurity and neurodevelopmental delays. The difference in the overall incidence of impairment among the 1-year survivors in the air placebo group (43 of 122 [35%]) and in the synthetic surfactant group (40 of 138 [29%]) was not statistically significant. The results of this 1-year follow-up study show that rescue treatment with synthetic surfactant in infants weighing 700 to 1300 gm is not associated with adverse developmental consequences despite the improvement in survival. (J P EDIATR 1995;126:S68-74.).

Original languageEnglish (US)
Pages (from-to)S68-S74
JournalThe Journal of Pediatrics
Volume126
Issue number5 SUPPL.
DOIs
StatePublished - May 1995

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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