Sepsis Clinical Trial
Official title:
Randomized Trial of Vitamin A Supplementation for Extremely-Low-Birth-Weight
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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