A Phase 1/2 interventional study of Vitamin A and Sham Procedure in Infant, Newborn, Infant, Low Birth Weight and Infant, Small for Gestational Age, sponsored by NICHD Neonatal Research Network. Completed at 11 sites in United States. Open to participants aged 24 Hours to 96 Hours. Per ClinicalTrials.gov, last updated 2017-09-26.
Sponsored by NICHD Neonatal Research Network · Phase 1/2, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
Vitamin A group.
Drug: Vitamin A
Sham procedure Control group.
Other: Sham Procedure
5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks.
Control infants received a sham procedure rather than placebo injections.
Chronic lung disease or death
Chronic lung disease was defined as the need for oxygen at 36 weeks' postmenstrual age.
Time frame: 36 weeks' postmenstrual age
Sepsis
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).
Time frame: 5 days
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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