NCT01203488

Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants

Randomized Trial of Vitamin A Supplementation for Extremely-Low-Birth-Weight

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 807 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 24 Hours – 96 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Bronchopulmonary Dysplasia
• Respiration, Artificial
• Respiratory Distress Syndrome, Newborn
• Sepsis

Interventions

Type	Name	Description
DRUG	Vitamin A	5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks.
OTHER	Sham Procedure	Control infants received a sham procedure rather than placebo injections.

Timeline

• Start date: 1996-01-01
• Primary completion: 1997-07-01
• Completion: 1999-07-01
• First posted: 2010-09-16
• Last updated: 2017-09-26

Locations

11 sites across 1 country: United States