Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
Randomized Trial of Vitamin A Supplementation for Extremely-Low-Birth-Weight
Eligibility Criteria
- * Infants wtih birth weights from 401-1,000g* Receiving mechanical ventilation or supplemental oxygen at 24-96 hours of age
- * Major congenital anomalies* Congenital nonbacterial infection* Infants diagnosed with a terminal illness (as indicated by a pH below 6.80 or by the presence of hypoxia with bradycardia for more than two hours)* Infants who were to receive vitamin A in a parenteral fat emulsion or in doses exceeding recommendations for multivitamin preparations
Investigator(s)
View on ClinicalTrials.gov
