Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Status:
Completed
Trial end date:
1999-07-01
Target enrollment:
Participant gender:
Summary
This multi-site, randomized trial was conducted to determine the safety and effectiveness of
a higher dose of vitamin A and determine if this would increase the rate of survival without
bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights
from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours
of age were enrolled. Subjects were randomized to either the Vitamin A or a control group.
Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on
Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure
rather than placebo injections.