Vitamin A Oral Supplementation as a Preventive Treatment for Chronic Lung Disease Among Infants Born Before 29 Weeks of Gestation.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Incidence of BPD at 28 days
研究概览
简要总结
Chronic bronchopulmonary dysplasia (BPD) is a very common complication in preterm infants born at a young gestational age, and is a serious disease that impairs respiratory long-term outcome and is associated with higher-frequency neurodevelopmental injury. Lowering the incidence of BPD may improve the health of the preterm babies and neurodevelopmental delay of preterm infants.Vitamin A deficiency may be one of the factors associated with the development of BPD in preterm infants. According to the literature, oral vitamin A administration can lower the incidence of BPD. In our study we plan to give 5000 units of retinol / dose / day, every day for 28 days.
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, Investigator)
入排标准
- 年龄范围
- 2 Days 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature babies under 29 weeks, at any birth weight
- •A preterm baby is less than 4 days to life
排除标准
- •Major congenital malformations
- •Known chromosomal disorders
结局指标
主要结局
Incidence of BPD at 28 days
时间窗: 28 days of life
Chronic pulmonary desease of prematue babies
Incidence of mortality at 28 days
时间窗: 28 days of life
Death before 28 days of life
次要结局
未报告次要终点
研究者
Dr. Leah Leibovitch MD
MD
Sheba Medical Center