Bronchopulmonary Dysplasia, Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age, Respiration, Artificial, Respiratory Distress Syndrome, Newborn, Sepsis
Conditions
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Vitamin A, Chronic Lung Disease
Brief 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.
Interventions
DRUGVitamin A
5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks.
OTHERSham Procedure
Control infants received a sham procedure rather than placebo injections.
Sponsors
National Center for Research Resources (NCRR)
NICHD Neonatal Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Hours to 96 Hours
Healthy volunteers
No
Inclusion criteria
* Infants wtih birth weights from 401-1,000g * Receiving mechanical ventilation or supplemental oxygen at 24-96 hours of age
Exclusion criteria
* Major congenital anomalies * Congenital nonbacterial infection * Infants diagnosed with a terminal illness (as indicated by a pH below 6.80 or by the presence of hypoxia with bradycardia for more than two hours) * Infants who were to receive vitamin A in a parenteral fat emulsion or in doses exceeding recommendations for multivitamin preparations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic lung disease or death | 36 weeks' postmenstrual age | Chronic lung disease was defined as the need for oxygen at 36 weeks' postmenstrual age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sepsis | 5 days | 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). |
Countries
United States
Outcome results
None listed