One-year follow-up of 66 premature infants weighing 500 to 699 grams treated with a single dose of synthetic surfactant or air placebo at birth: Results of a double-blind trial☆,☆☆,★
Section snippets
METHODS
This single-dose prophylactic trial in infants weighing 500 to 699 gm was conducted with a common protocol at 23 hospitals in the United States. Between October 1987 and December 1989, 215 infants were enrolled in the study; 109 infants were treated with air placebo, and 106 were treated with synthetic surfactant (Exosurf Neonatal, Burroughs Wellcome Co., Research Triangle Park, N.C.). Assessment methods used at 1-year adjusted age included physical and neurologic examinations, measurement of
RESULTS
Of the 215 infants enrolled in the trial, 80 (37%) survived infancy: 40 of 109 (37%) in the control group and 40 of 106 (38%) in the synthetic surfactant group ( Table I). Fourteen infants were lost to follow-up or their families failed to return for follow-up; thus 36 (90%) of the infants who survived in the control group and 30 (75%) of the infants who survived in the surfactant group were examined at 1-year adjusted age. The birth weights and gestational ages were similar for both groups (
DISCUSSION
Prophylactic treatment with a single dose of synthetic surfactant in infants with birth weights of 500 to 699 gm reduces neonatal mortality caused by RDS, the incidence of pulmonary air leaks, and the need for ventilatory assistance and oxygen requirements through 3 days of age, 3 indicating a positive effect on lung function in extremely premature infants. Infants in this weight category are near the threshold of viability, and the long-term prognosis of survivors is guarded. Infant mortality
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Cited by (0)
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From the Departments of Pediatrics, King/Drew Medical Center and UCLA School of Medicine, Los Angeles, California; West Virginia University School of Medicine, Morgantown; University of Michigan Hospitals, Ann Arbor; Vanderbilt University Medical Center, Nashville, Tennessee; Kapiolani Medical Center for Women and Children, Honolulu, Hawaii; University of North Carolina at Chapel Hill; and participating centers
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Reprint requests: Frans J. Walther, MD, Department of Pediatrics, King/Drew Medical Center, 12021 S. Wilmington Ave, Los Angeles, CA 90059.
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0022-3476/95/$3.00 + 0 9/0/61826