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
- 180
- 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
- •A 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. Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.
干预措施: Placebo (Dietary Supplement)
Usual care plus placebo
Infants will receive placebo (normal saline) in the first 28 days after birth. Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.
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 (when feedings reach about 120 -160 mL/kg/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 (when feedings reach about 120 -160 mL/kg/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
- 25-hydroxyvitamin D (25[OH]D) level(36 weeks after birth)
- Type of respiratory support required at 36 weeks postmenstrual age(36 weeks postmenstrual age (or at the time of discharge home if earlier))
- 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 days of supplemental oxygen(from time of birth to time of discharge (about 0 to 60 weeks after birth))
- Number of days of mechanical ventilation(from time of birth to time of discharge (about 0 to 60 weeks after birth))
- Number of days of positive pressure support(from time of birth to time of discharge (about 0 to 60 weeks after birth))
- Number of participants who receive steroid treatment to decrease respiratory support(from baseline to 36 weeks postmenstrual age)
- Number of participants with pulmonary hypertension(36 weeks postmenstrual age)
- Number of participants with recurrent wheezing(2 years)
- Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator(2 years)
- Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator(2 years)
- Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator(2 years)
- Number of participants with any fractures(from baseline to 36 weeks postmenstrual age)
- 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)
- Phosphorus level(0 to 36 weeks postmenstrual age)
- Alkaline phosphatase level(0 to 36 weeks postmenstrual age)
- Neurodevelopment as assessed by the Bayley-IV Scales of Infant and Toddler Development(2 years)
- Number of participants with neurodevelopmental impairment (NDI)(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 24,25(OH)2D3 as assessed by LC-MS/MS(36 weeks postmenstrual age)
- Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS(36 weeks postmenstrual age)
- Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS(36 weeks postmenstrual age)
- Pre-discharge health system costs(From time of birth to time of discharge (about 0 to 60 weeks after birth))
- Cost-effectiveness in preventing days of respiratory support(From time of birth to time of discharge (about 0 to 60 weeks after birth))
- Cost-effectiveness in increasing survival without BPD(From time of birth to time of discharge (about 0 to 60 weeks after birth))
研究者
Maria del Mar Romero López
Assistant Professor
The University of Texas Health Science Center, Houston