Double-blind, randomized trial of one versus three prophylactic doses of synthetic surfactant in 826 neonates weighing 700 to 1100 grams: Effects on mortality rate - 07/10/14
Abstract |
At 33 hospitals in the United States, a double-blind, randomized clinical trial was performed to compare one versus three prophylactic doses of synthetic surfactant in 700 to 1100 gm inborn infants. All 826 infants received an initial prophylactic dose of surfactant within 30 minutes of birth. Subsequently 410 infants received two doses of placebo (air) 12 and 24 hours later, and 416 infants received two additional doses of surfactant. By the age of 28 days, 70 infants who received one dose of surfactant and 40 infants who received three doses were dead, a 43% relative reduction in the mortality rate (30 fewer deaths; p = 0.002). By the age of 1 year after term, 87 infants who received one dose and 62 infants who received three doses were dead: a 29% relative reduction in the mortality rate (25 fewer deaths; p = 0.027). Infants who received three doses of surfactant required significantly less oxygen and less mean airway pressure for the first week of life. Necrotizing enterocolitis (9 vs 25 infants; p = 0.005), and use of high-frequency ventilation (13 vs 26 infants; p = 0.037); pancuronium (43 vs 62 infants; p = 0.045); and leukocyte transfusions (0 vs 4 infants; p = 0.042) were less frequent in the three-dose group, but air leak, bronchopulmonary dysplasia, intraventricular hemorrhage, patent ductus arteriosus, pulmonary hemorrhage, and infections were not different. These results indicate that physiologic findings, mortality rates, and probably morbidity rates are improved by two additional prophylactic doses of synthetic surfactant. (J PEDIATR 1995;126:969-78)
Le texte complet de cet article est disponible en PDF.Abbreviations : BPD, CI, IVH, NEC, PDA, PO2, RDS
Plan
From the Departments of Pediatrics, Emory University, Atlanta, Georgia; Pennsylvania Hospital and University of Pennsylvania, Philadelphia; University of North Carolina at Chapel Hill; Cedar Sinai Medical Center, Los Angeles, California; Children's Hospital and University of Colorado Health Sciences Center, Denver; Alaska Neonatology Associates, Anchorage; the Department of Clinical Statistics, Burroughs Wellcome Co., Research Triangle Park, North Carolina; Kosair Children's Hospital and University of Louisville, Louisville, Kentucky; and participating centers |
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Supported by Burroughs Wellcome Co., Research Triangle Park, N.C. |
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Reprint requests: Walker Long, MD, CB 7220, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7220. |
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aMembers of the study groups are listed after the text. |
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♢ | 0022-3476/95/$3.00 + 0 9/23/63159 |
Vol 126 - N° 6
P. 969-978 - juin 1995 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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