Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants

• Status: Completed
• Trial end date: 1999-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Retinol palmitate; Vitamin A; Vitamins

Criteria

Inclusion Criteria:

• Infants wtih birth weights from 401-1,000g

• Receiving mechanical ventilation or supplemental oxygen at 24-96 hours of age

Exclusion Criteria:

• 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