Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serum vitamin D concentration
研究概览
简要总结
The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.
详细描述
After informed consent obtained, infants will be randomized using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to one of the treatment arms or to a placebo concurrent control.
Early vitamin D supplementation/placebo will be initiated within the first 7 days after birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D: either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. After this period of supplementation, routine supplementation will be conducted in all groups.
Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D [25(OH)D]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found.
Supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations >60ng/mL (>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If infant made briefly NPO (<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D will not be discontinued.
All infants will be followed to discharge for primary, secondary outcomes as well as adverse events.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks
排除标准
- •Major congenital/chromosomal anomalies
- •Moribund infant with low likelihood of survival, in opinion of the clinical team
研究组 & 干预措施
Placebo
Identical-appearing treatment that does not contain the test drug given orally four times per day.
干预措施: Placebo (Dietary Supplement)
Oral Vitamin D--800 IU/day
Cholecalciferol 800 IU given orally once per day
干预措施: Cholecalciferol (Dietary Supplement)
Oral Vitamin D--200 IU/day
Cholecalciferol 200 IU given orally once per day
干预措施: Cholecalciferol (Dietary Supplement)
结局指标
主要结局
Serum vitamin D concentration
时间窗: Day after birth 28
Serum vitamin D levels determined by enzyme immunoassay obtained from whole blood (remnant sample or obtained during clinical blood draw)
Total number of days alive and off respiratory support in the first 28 days
时间窗: 28 days
The total number of days alive and off respiratory support. Respiratory support is defined as need of supplemental oxygen and/or positive pressure ventilation to maintain normal target oxygen saturations (88-95%).
次要结局
- Death(Participants will be followed for the duration of hospital stay, an expected average of 4 months)
- Sepsis(Participants will be followed for the duration of hospital stay, an expected average of 4 months)
- Duration of mechanical ventilation after randomization(Participants will be followed for the duration of hospital stay, an expected average of 4 months)
- Need for supplemental oxygen at 36 weeks of corrected age (Physiologic definition)(36 weeks gestational age corrected)
- Urine calcium level(Participants will be followed for the duration of hospital stay, an expected average of 4 months)
- Number of sepsis episodes treated with antibiotics for at least 5 days(Participants will be followed for the duration of hospital stay, an expected average of 4 months)
- Days alive and off mechanical ventilation in the first 28 days after birth(28 days)
- Surgical necrotizing enterocolitis or intestinal perforation(Participants will be followed for the duration of hospital stay, an expected average of 4 months)
- Number of re-intubation events(Participants will be followed for the duration of hospital stay, an expected average of 4 months)
- 25(OH)D concentrations >60ng/ml (150 nmol/L)(28 days postnatal age (+/- 3 days))
- Serum calcium level(Participants will be followed for the duration of hospital stay, an expected average of 4 months)
- Meningitis(Participants will be followed for the duration of hospital stay, an expected average of 4 months)
- 25(OH)D concentrations >60ng/ml (150 nmol/L)(14 postnatal (+/- 2 days))
研究者
Namasivayam Ambalavanan
Professor of Pediatrics
University of Alabama at Birmingham