Education and Training
Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Vitamin A
- other: Sham Procedure
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
Ages Eligible for Study
24 Hours - 96 Hours
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting