Brief Title
Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Official Title
Randomized Trial of Vitamin A Supplementation for Extremely-Low-Birth-Weight
Brief 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.
Detailed Description
Infants with extremely low birth weights (≤1,000 g) have low plasma and tissue concentrations
of vitamin A, and vitamin A deficiency may predispose these infants to chronic lung disease.
A meta-analysis of clinical trials of vitamin A supplementation for preterm infants revealed
a 17% increase in the rate of survival without chronic lung disease, which approached
statistical significance.
This multi-site, randomized trial was conducted to determine the safety and effectiveness of
a higher dose of vitamin A than that used in previous trials in extremely-low-birth-weight
(ELBW) infants. We hypothesized that vitamin A supplementation would increase the rate of
survival without bronchopulmonary dysplasia and reduce the risk of sepsis.
Infants with birth weights from 401-1000g and who received 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.
Serum vitamin A was measured in a central laboratory at base line and at 28 days in the first
300 infants. On study day 28 (two to three days after the last treatment and immediately
after a blood sample was collected), the relative dose-response was evaluated.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Chronic lung disease or death
Secondary Outcome
Sepsis
Condition
Infant, Newborn
Intervention
Vitamin A
Study Arms / Comparison Groups
Experimental
Description: Vitamin A group.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
807
Start Date
January 1996
Completion Date
July 1999
Primary Completion Date
July 1997
Eligibility 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
Gender
All
Ages
N/A - 96 Hours
Accepts Healthy Volunteers
No
Contacts
Jon E. Tyson, MD MPH, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01203488
Organization ID
NICHD-NRN-0015
Secondary IDs
U10HD021373
Study Sponsor
NICHD Neonatal Research Network
Collaborators
National Center for Research Resources (NCRR)
Study Sponsor
Jon E. Tyson, MD MPH, Study Director, University of Texas Southwestern Medical Center
Verification Date
September 2017