TY - JOUR
T1 - 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
AU - Gong, Alice
AU - Anday, Endla
AU - Boros, Stephen
AU - Bucciarelli, Richard
AU - Burchfield, David
AU - Zucker, Janet
AU - Long, Walker
N1 - Copyright:
Copyright 2014 Elsevier B.V., All rights reserved.
PY - 1995/5
Y1 - 1995/5
N2 - 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.).
AB - 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.).
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U2 - 10.1016/S0022-3476(95)70010-2
DO - 10.1016/S0022-3476(95)70010-2
M3 - Article
C2 - 7745514
AN - SCOPUS:0029031408
SN - 0022-3476
VL - 126
SP - S68-S74
JO - The Journal of pediatrics
JF - The Journal of pediatrics
IS - 5 SUPPL.
ER -