Overview

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