Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 25-hydroxyvitamin D (25[OH]D) level
研究概览
简要总结
The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are <28 weeks gestational age (GA) or <1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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 born at < 28 weeks gestational age (GA) or <1000 grams birth weight (BW)
- •Informed written consent in an Institutional Review Board (IRB)-approved manner
排除标准
- •GA >32 weeks regardless of birth weight (BW)
- •Any major congenital anomaly
- •An known congenital nonbacterial infection
- •Prenatal diagnosis of disorders that affect vitamin D absorption (e.g, cystic fibrosis)
- •Such severe illness or immaturity that the attending neonatologist judges intensive care to be unjustified.
研究组 & 干预措施
Usual care plus placebo
Infants will receive placebo (normal saline) in the first 28 days after birth. Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices.
干预措施: Placebo (Dietary Supplement)
Usual care plus placebo
Infants will receive placebo (normal saline) in the first 28 days after birth. Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices.
干预措施: Usual Care (Other)
Usual care plus vitamin D supplementation
Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day. At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.
干预措施: 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth (Dietary Supplement)
Usual care plus vitamin D supplementation
Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day. At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.
干预措施: Usual Care (Other)
结局指标
主要结局
25-hydroxyvitamin D (25[OH]D) level
时间窗: about 28 days after birth
次要结局
- Number of days of supplemental oxygen(from time of birth to time of discharge (about 0 to 60 weeks after birth))
- Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by LC-MS/MS(36 weeks postmenstrual age)
- Length of Hospital stay(from time of birth to time of discharge (about 0 to 60 weeks after birth))
- Number of participants who are still on respiratory support(22 to 26 months corrected age)
- Number of participants with pulmonary hypertension(36 weeks postmenstrual age)
- 25-hydroxyvitamin D (25[OH]D) level(36 weeks after birth)
- Number of participants with neurodevelopmental impairment (NDI)(2 years)
- Number of days of mechanical ventilation(from time of birth to time of discharge (about 0 to 60 weeks after birth))
- Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator(2 years)
- Number of participants with hospital-acquired sepsis(from day 3 after birth to the time of discharge (which is 0 to 60 weeks after birth))
- Calcium level(0 to 36 weeks postmenstrual age)
- Number of participants with wheezing(2 years)
- Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Language composite score)(2 years)
- Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS(36 weeks postmenstrual age)
- Type of respiratory support required at 36 weeks postmenstrual age(36 weeks postmenstrual age (or at the time of discharge home if earlier))
- Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator(2 years)
- Alkaline phosphatase level(0 to 36 weeks postmenstrual age)
- Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Motor composite score)(2 years)
- Number of days of positive pressure support(from time of birth to time of discharge (about 0 to 60 weeks after birth))
- Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator(2 years)
- Number of participants who receive steroid treatment to decrease respiratory support(from baseline to 36 weeks postmenstrual age)
- Number of participants with any fractures(from baseline to 36 weeks postmenstrual age)
- Phosphorus level(0 to 36 weeks postmenstrual age)
- Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Cognitive composite score)(2 years)
- Number of participants who die or have a morbidity(36 weeks postmenstrual age)
- Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by Liquid Chromatography with tandem mass spectrometry (LC-MS/MS)(about 28 days after birth)
- Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS(36 weeks postmenstrual age)
研究者
Maria del Mar Romero López
Assistant Professor
The University of Texas Health Science Center, Houston