Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Condition: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Bronchopulmonary Dysplasia; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Sepsis
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Body Weight; Birth Weight
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Vitamin A; Sham Procedure
Intervention type(s): Drug; Other
Intervention description(s): 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.
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Prematurity; Vitamin A; Chronic Lung Disease