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Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Not Recruiting
Trial ID: NCT01203488
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
Stanford Investigator(s)
Eligibility
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
Intervention(s):
drug: Vitamin A
other: Sham Procedure
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305