Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
NCT ID: NCT01203488 Phase: PHASE1 Status: COMPLETED Enrollment: 807 Completion: 1999-07
Conditions
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia, Respiration, Artificial, Respiratory Distress Syndrome, Newborn, Sepsis
Interventions
Vitamin A, Sham Procedure
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.
Primary Outcome
Chronic lung disease or death