One-hundred infants admitted to Texas Children's Hospital Neonatal Intensive Care Unit from Nov. 1979 to Nov. 1980 who weighed ≤1500 grams at birth and who developed respiratory distress were given orally either 5 mg/kg/day (control) or 100 mg/kg/day (experimental) of dl-α-tocopherol (vitamin E) beginning on their first day of life and continuing throughout their hospital stay on a randomized double-blind basis. Blood levels of vitamin E were found to average 6 ugm/ml in the controls and 12 ugm/ml in the experimentals after 7 days. Each infant had a weekly retinal evaluation beginning at the third week of life. The critical time for screening and treatment for retinopathy of prematurity (ROP) was found to be seven weeks post-delivery. The significant ROP risk factors identified in the controls were gestational age, birth weight, oxygen administration, intraventricular hemorrhage, and sepsis.
There was no difference between the two groups in clinically insignificant ROP (grade II or less). However, the incidence of grade III ROP in the control population was 10% (5 of 50) while no grade III ROP developed in the experimental infants. The correlation between the development of grade III ROP and the lower level of vitamin E administration was found to be highly significant (p<.02).
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Hittner, H., Monaco, W., Godio, L. et al. 1328 RETINOPATHY OF PREMATURITY: ADMINISTRATION OF VITAMIN E TO MITIGATE AGAINST SEVERE DISEASE. Pediatr Res 15, 664 (1981). https://doi.org/10.1203/00006450-198104001-01357