Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Infant, Low Birth Weight
Infant, Small for Gestational Age
Respiratory Distress Syndrome, Newborn
Drug: Vitamin A
Other: Sham Procedure
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Randomized Trial of Vitamin A Supplementation for Extremely-Low-Birth-Weight|
- Chronic lung disease or death [ Time Frame: 36 weeks' postmenstrual age ] [ Designated as safety issue: Yes ]Chronic lung disease was defined as the need for oxygen at 36 weeks' postmenstrual age.
- Sepsis [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]Sepsis was defined on the basis of a positive blood culture and treatment with antibiotics for at least five days (unless the infant died within five days).
|Study Start Date:||January 1996|
|Study Completion Date:||July 1999|
|Primary Completion Date:||July 1997 (Final data collection date for primary outcome measure)|
Vitamin A group.
Drug: Vitamin A
5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks.
Sham Comparator: Control
Sham procedure Control group.
Other: Sham Procedure
Control infants received a sham procedure rather than placebo injections.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203488
|United States, California|
|Palo Alto, California, United States, 94304|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06504|
|United States, District of Columbia|
|George Washington University|
|Washington, District of Columbia, United States, 20052|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Georgia|
|Atlanta, Georgia, United States, 30303|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Ohio|
|Cincinnati Children's Medical Center|
|Cincinnati, Ohio, United States, 45267|
|Case Western Reserve University, Rainbow Babies and Children's Hospital|
|Cleveland, Ohio, United States, 44106|
|United States, Rhode Island|
|Brown University, Women & Infants Hospital of Rhode Island|
|Providence, Rhode Island, United States, 02905|
|United States, Tennessee|
|University of Tennessee|
|Memphis, Tennessee, United States, 38163|
|United States, Texas|
|University of Texas Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75235|
|Study Director:||Jon E. Tyson, MD MPH||University of Texas Southwestern Medical Center|
|Principal Investigator:||William Oh, MD||Brown University, Women and Infants Hospital|
|Principal Investigator:||Joel Verter, PhD||George Washington University Biostatistics Center|
|Principal Investigator:||Richard A. Ehrenkranz, MD||Yale University|
|Principal Investigator:||Barbara J. Stoll, MD||Emory University|
|Principal Investigator:||James A. Lemons, MD||Indiana University|
|Principal Investigator:||David K. Stevenson, MD||Stanford University|
|Study Director:||Charles R. Bauer, MD||University of Miami|
|Principal Investigator:||Sheldon B. Korones, MD||University of Tennessee|
|Principal Investigator:||Edward F. Donovan, MD||Case Western Reserve University|