Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm: A Randomized Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Severity of respiratory morbidity
研究概览
简要总结
This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin D dose recommended during the first 14 days after birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age of 28 weeks or less
排除标准
- •Major congenital anomalies and infants
- •Terminal illness in whom decisions to withhold or limit life support have been made
研究组 & 干预措施
Control group
干预措施: No additional vitamin D supplementation (Other)
Vitamin D group
干预措施: Vitamin D supplementation (Dietary Supplement)
结局指标
主要结局
Severity of respiratory morbidity
时间窗: 0 - 120 days
A scoring system that defines severity of respiratory morbidity based on the amount of ventilatory support and the need for supplemental oxygen
Non-invasive oscillometry (NiOS) measurements of pulmonary mechanics
时间窗: 40 - 120 days
Using the tremoflo N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)
次要结局
- Bronchopulmonary dysplasia(36 weeks PMA or discharge)
研究者
Ariel A. Salas
Associate Professor
University of Alabama at Birmingham