Influence on retrolental fibroplasia of intramuscular vitamin E administration during respiratory distress syndrome.

The effect of vitamin E administered during the acute phase of therapy for respiratory distress syndrome (RDS) on the development of retinopathy of prematurity (ROP) was evaluated in a randomized double-masked study. One hundred neonates received either vitamin E or placebo intramuscularly within the first 24 hours of birth and at 24, 48, and 168 hours respectively. Additional doses were given twice weekly while the infant remained in an oxygen-enriched environment and could not tolerate feedings and vitamin supplements. Parenteral vitamin E-treated infants had significantly increased serum vitamin E levels compared to placebo-treated infants. Most placebo-treated patients attained normal serum vitamin E levels during the second week of life because of nutritional sources of vitamin E. Infants in both groups had RDS of similar severity. Seventy-four infants, 37 vitamin E-treated and 37 placebo-treated, survived longer than 10 days and had ophthalmologic examinations. Active changes of Stage I and Stage II ROP were noted in 17 of those patients; 9 (24.3%) vitamin E-treated and 8 (21.6%) placebo-treated patients (P = 0.572). No infants developed severe cicatricial changes, and their retinal findings regressed. The incidence of risk factors associated with ROP development occurred equally in the vitamin E-treated and placebo-treated infants that developed ROP. Thus, vitamin E-administration as described in this study did not result in any further reduction in the incidence of the active stages of ROP over that seen with standard neonatal care, which included daily oral Vitamin E supplements.

RCT Entities:   Population Interventions Outcomes