TY - JOUR
T1 - Controlled trial of a single dose of synthetic surfactant at birth in premature infants weighing 500 to 699 grams
AU - Stevenson, David
AU - Walther, Frans
AU - Long, Walker
AU - Sell, Matthew
AU - Pauly, Thomas
AU - Gong, Alice
AU - Easa, David
AU - Pramanik, Arun
AU - LeBlanc, Michael
AU - Anday, Endla
AU - Dhanireddy, Ramasubbareddy
AU - Burchfield, David
AU - Corbet, Anthony
N1 - Funding Information:
Supported by funds from Burroughs Wellcome Co., Research Triangle Park, N.C.
PY - 1992/2
Y1 - 1992/2
N2 - In a multicenter, double-blind, placebo-controlled trial conducted at 23 hospitals in the United States, a single prophylactic 5 ml/kg dose of a synthetic surfactant (Exosurf Neonatal) or air placebo was administered shortly after birth to 215 infants with birth weights of 500 to 699 gm. Despite stratification at entry by birth weight and gender, by chance female infants predominated in the air placebo group and male infants predominated in the surfactant group. Among infants receiving synthetic surfactant, improvements in oxygen requirements were significant at 2 hours after birth (p=0.014) and persisted for 3 days (p=0.001); improvements in the alveolar-arterial partial pressure of oxygen gradient were significant at 6 hours after birth (p=0.01) and persisted for 3 days (p=0.008). Improvements in mean airway pressure were not significant at 2 or at 6 hours after birth (p=0.622 and 0.083, respectively), but became significant thereafter and persisted for 3 days (p=0.002). Pneumothorax was reduced by slightly more than half (25 vs 11; p=0.014); death from respiratory distress syndrome (RDS) was also reduced (26 vs 15; p=0.046). Overall neonatal mortality, however, was not significantly reduced (58 vs 46; p=0.102). Other complications of RDS and prematurity were not altered, except that pulmonary hemorrhage occurred significantly more frequently in infants receiving synthetic surfactant (2 vs 12; p=0.006). These findings indicate that a single prophylactic dose of synthetic surfactant in infants weighing 500 to 699 gm at birth improves lung function, incidence of air leak, and death from RDS but not overall mortality. The only safety problem identified was an increase in pulmonary hemorrhage.
AB - In a multicenter, double-blind, placebo-controlled trial conducted at 23 hospitals in the United States, a single prophylactic 5 ml/kg dose of a synthetic surfactant (Exosurf Neonatal) or air placebo was administered shortly after birth to 215 infants with birth weights of 500 to 699 gm. Despite stratification at entry by birth weight and gender, by chance female infants predominated in the air placebo group and male infants predominated in the surfactant group. Among infants receiving synthetic surfactant, improvements in oxygen requirements were significant at 2 hours after birth (p=0.014) and persisted for 3 days (p=0.001); improvements in the alveolar-arterial partial pressure of oxygen gradient were significant at 6 hours after birth (p=0.01) and persisted for 3 days (p=0.008). Improvements in mean airway pressure were not significant at 2 or at 6 hours after birth (p=0.622 and 0.083, respectively), but became significant thereafter and persisted for 3 days (p=0.002). Pneumothorax was reduced by slightly more than half (25 vs 11; p=0.014); death from respiratory distress syndrome (RDS) was also reduced (26 vs 15; p=0.046). Overall neonatal mortality, however, was not significantly reduced (58 vs 46; p=0.102). Other complications of RDS and prematurity were not altered, except that pulmonary hemorrhage occurred significantly more frequently in infants receiving synthetic surfactant (2 vs 12; p=0.006). These findings indicate that a single prophylactic dose of synthetic surfactant in infants weighing 500 to 699 gm at birth improves lung function, incidence of air leak, and death from RDS but not overall mortality. The only safety problem identified was an increase in pulmonary hemorrhage.
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U2 - 10.1016/S0022-3476(05)81226-0
DO - 10.1016/S0022-3476(05)81226-0
M3 - Article
C2 - 1735849
AN - SCOPUS:0026542111
SN - 0022-3476
VL - 120
SP - S3-S12
JO - The Journal of pediatrics
JF - The Journal of pediatrics
IS - 2 PART 2
ER -