Retrolental fibroplasia: efficacy of vitamin E in a double-blind clinical study of preterm infants

N Engl J Med. 1981 Dec 3;305(23):1365-71. doi: 10.1056/NEJM198112033052301.


We performed a double-blind study in 101 preterm infants who weighed less than or equal to 1500 g at birth, who had respiratory distress, and who survived for at least four weeks, to evaluate the efficacy of oral vitamin E in preventing the development of retrolental fibroplasia. Weekly indirect ophthalmologic examinations begun when the infants were three weeks old revealed a significant decrease in the incidence of retrolental fibroplasia greater than or equal to Grade III (P less than 0.03) and greater than or equal to Grade II (P less than 0.05) (McCormick classification) in the 50 infants given 100 mg of vitamin E per kilogram of body weight per day as compared with 51 given 5 mg per kilogram per day (controls). When multivariate analysis was applied to the controls, five risk factors were identified: gestational age, level and duration of administration oxygen, intraventricular hemorrhage, sepsis, and birth weight. When multivariate analysis was applied to both control and treatment groups, the severity of retrolental fibroplasia was found to be significantly reduced in infants given 100 mg of vitamin E (P = 0.012).

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Birth Weight
  • Cerebral Hemorrhage / complications
  • Clinical Trials as Topic
  • Double-Blind Method
  • Gestational Age
  • Humans
  • Infant, Newborn
  • Oxygen Inhalation Therapy / adverse effects
  • Respiratory Distress Syndrome, Newborn / complications
  • Respiratory Distress Syndrome, Newborn / therapy
  • Retinopathy of Prematurity / etiology
  • Retinopathy of Prematurity / prevention & control*
  • Risk
  • Vitamin E / administration & dosage
  • Vitamin E / blood
  • Vitamin E / therapeutic use*


  • Vitamin E