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Tocopherol efficacy and safety for preventing retinopathy of prematurity: a randomized, controlled, double-masked
Insights
Vitamin E (tocopherol) did not prevent retinopathy of prematurity in premature infants. This treatment may increase the risk of retinal hemorrhage and severe intraventricular hemorrhage in very low birth weight infants.
Area of Science:
- Neonatology
- Ophthalmology
- Pharmacology
Background:
- Retinopathy of prematurity (ROP) is a significant cause of visual impairment in premature infants.
- Vitamin E (tocopherol) has been investigated for its potential prophylactic effects against ROP.
Purpose of the Study:
- To evaluate the efficacy and safety of intravenous (IV) followed by oral tocopherol in preventing retinopathy of prematurity in high-risk premature infants.
Main Methods:
- A randomized, double-masked trial involving 287 infants with birth weights < 1.5 kg or gestational ages < 33 weeks.
- Infants received either IV/oral placebo or tocopherol, with adjustments to maintain plasma levels of 3 to 3.5 mg/dL.
Main Results:
- Tocopherol did not prevent ROP of any stage or moderately severe ROP.
- Increased incidence of retinal hemorrhage was observed in tocopherol-treated infants.
- Higher rates of grades 3 and 4 intraventricular hemorrhage occurred in infants < 1 kg treated with tocopherol compared to placebo.
Conclusions:
- Current data do not support using tocopherol for ROP prophylaxis in premature infants.
- Early IV tocopherol administration may elevate the risk of hemorrhagic complications, particularly in very low birth weight infants.
Abstract:
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 less than .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 less than .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.