Intramuscular Followed by Oral Vitamin A Supplementation in Neonates with Birth Weight from 750 to 1250g: A Randomized Controlled Trial.

Abstract

Multiple intramuscular (IM) injections of vitamin A have been shown to decrease bronchopulmonary dysplasia in very low birth weight (VLBW) neonates. However, this regime is neither practical nor popular. Oral vitamin A has failed to achieve adequate plasma levels. We aimed to investigate if a schedule of initial IM followed by oral supplementation can reduce vitamin A deficiency. This was a blinded, randomized controlled trial, conducted in a level III neonatal unit. Neonates with birth weight from 750 to 1250g, were enrolled at the age of 24-96h of life. They were randomly allocated to vitamin A supplementation (VAS) (n = 61) or placebo group (n = 59). VAS group received vitamin A 5000IU IM on alternate days till establishment of adequate enteral feeds, followed by oral 10,000IU daily for 28days. The primary outcome was incidence of vitamin A deficiency (plasma retinol < 200μg/L) on day 28. A total of 120 neonates with mean (SD) gestation age and birth weight of 31 (2.4) weeks and 1065 (141)g, respectively were enrolled. More than 90% of cases were vitamin A deficient at the baseline. The proportion of vitamin A deficient infants on day 28 of study was significantly lower in VAS group compared to placebo group (4% vs. 61%, p < 0.001). The median (1st-3rd quartile) plasma retinol levels (μg/L) were significantly higher in VAS group compared to placebo [489 (295,627) vs. 184 (156,240), p < 0.001]. We conclude that the IM followed by oral VAS significantly reduced the incidence of vitamin A deficiency in VLBW infants.