Abstract
287 infants were enrolled in a double masked, randomized controlled trial of vitamin E (E) v placebo (P) given from day 1 until the retinal vessels reached the ora serrata. Initial IV doses were changed to oral after the infants fed well. The first dose of E was 20mg/kg, the mean dose to maintain plasma levels at 3-3.5mg/dL during the first week was 15±6mg/kg/d, and during the second week was 3±4mg/kg/day.
Mortality (20% P v 22% E), acquired sepsis (7% P v 6% E), confirmed NEC (4% P v 4% E) days of phototherapy (5.4±3.9 P v 5.9±4.3 E, X±SD), and length of hospitalization (62±40 P v 63±41 days E) did not differ. Grades 3 and 4 CNS hemorrhage was more common in infants <1 kg who received E (14/42) than in those infants <1 kg who received P, (4/43), p<0.02.
28/99 P infants and 25/97 E infants who completed the study developed active ROP and in 8/99 P v 11/97 E it was grade 3 or worse ROP. One in each group developed retinal detachments, grade 4 cicatricial ROP. More E infants (16/111, 14%) than P infants (8/121, 7%) developed retinal hemorrhages, p<0.06. This was the only statistically or clincially significant difference for ROP outcome in these infants.
Based on these data, the potential benefits of E treatment do not outweigh the potential risks.
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Phelps, D., Rosenbaum, A., Isenberg, S. et al. 1481 EFFECT OF IV TOCOPHEROL (VIT E) ON RETINOPATHY OF PREMATURITY (ROP). Pediatr Res 19, 357 (1985). https://doi.org/10.1203/00006450-198504000-01505
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DOI: https://doi.org/10.1203/00006450-198504000-01505
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