Randomized Trial of Vitamin A Supplementation for Extremely-Low-Birth-Weight
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 807
- 试验地点
- 11
- 主要终点
- Chronic lung disease or death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Hours 至 96 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants wtih birth weights from 401-1,000g
- •Receiving mechanical ventilation or supplemental oxygen at 24-96 hours of age
排除标准
- •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
研究组 & 干预措施
Experimental
Vitamin A group.
干预措施: Vitamin A (Drug)
Control
Sham procedure Control group.
干预措施: Sham Procedure (Other)
结局指标
主要结局
Chronic lung disease or death
时间窗: 36 weeks' postmenstrual age
Chronic lung disease was defined as the need for oxygen at 36 weeks' postmenstrual age.
次要结局
- Sepsis(5 days)