PEDIATRICS Vol. 79 No. 4 April 1987, pp. 489-500
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Tocopherol Efficacy and Safety for Preventing Retinopathy of Prematurity: A Randomized, Controlled, Double-Masked Trial

Dale L. Phelps MD1, Arthur L. Rosenbaum MD2, Sherwin J. lsenberg MD3, Rosemary D. Leake MD4, and Frederick J. Dorey PhD5

1 The Department of Pediatrics, Jules Stein Eye Institute, University of California, Los Angeles
2 The Department of Orthopedics, Jules Stein Eye Institute, University of California, Los Angeles
3 The Department of Ophthalmology, Jules Stein Eye Institute, University of California, Los Angeles
4 Center for the Health Sciences, Los Angeles
5 Department of Pediatrics, Harbor-UCLA Medical Center, Torrance

To test the efficacy and safety of vitamin E in preventing retinopathy of prematurity, 287 infants with birth weights of less than 1.5 kg or gestational ages of less than 33 weeks were enrolled within 24 hours of birth in a randomized, double-masked trial of IV, followed by oral, placebo v tocopherol (adjusted to plasma levels of 3 to 3.5 mg/dL). In the 196 infants completing ophthalmic follow-up, tocopherol did not prevent retinopathy of prematurity of any stage (28% placebo treated v 26% tocopherol treated) or moderately severe retinopathy of prematurity (8% placebo treated v 11% tocopherol treated). Cicatricial sequelae were not significantly different (1/97 placebo treated v 3/99 tocopherol treated), with one placebo-treated infant and one tocopherol-treated infant having retinal detachments. Among all 232 infants examined, those treated with tocopherol had more retinal hemorrhage than placebo-treated infants (8/121 placebo treated v 16/111 tocopherol treated), and retinal hemorrhage correlated positively (P < .01) with plasma levels of tocopherol after the first 2 weeks of age. Prospective monitoring of morbidity including late-onset sepsis, necrotizing enterocolitis, etc revealed no differences between groups except that grades 3 and 4 intraventricular hemorrhage occurred more frequently in infants weighing less than 1 kg at birth who had received tocopherol (14/42, 33%) v those who had received placebo (4/43, 9%) (P < .02). Our data do not support the use of tocopherol for prophylaxis against retinopathy of prematurity in premature infants and suggest that IV tocopherol treatment starting on day 1 may increase the incidence of hemorrhagic complications of prematurity, particularly in infants with birth weights of less than 1 kg.

Key Words: retinopathy of prematurity • retrolental fibroplasia • vitamin E • tocopherol

Submitted on August 25, 1986
Accepted on October 13, 1986




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