Trial Search Results

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.

Lead Sponsor:

NICHD Neonatal Research Network

Collaborator: National Center for Research Resources (NCRR)

Stanford Investigator(s):

Intervention(s):

  • Drug: Vitamin A
  • Other: Sham Procedure

Phase:

Phase 1/Phase 2

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

N/A - 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