Vitamin D Supplementation for Extremely Preterm Infants
2017年2月8日 更新者：Namasivayam Ambalavanan、University of Alabama at Birmingham
Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial
The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
100
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Alabama
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Birmingham、Alabama、美国、35249
- University of Alabama at Birmingham
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1分钟 至 1周 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks
Exclusion Criteria:
- Major congenital/chromosomal anomalies
- Moribund infant with low likelihood of survival, in opinion of the clinical team
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Oral Vitamin D--200 IU/day
Cholecalciferol 200 IU given orally once per day
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200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours.
Other 3 doses will be placebo (sterile water).
Duration of 28 postnatal days
其他名称：
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours.
Duration of 28 postnatal days
其他名称：
|
|
安慰剂比较：Placebo
Identical-appearing treatment that does not contain the test drug given orally four times per day.
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Sterile water 0.5ml given orally every 6 hours.
Duration of 28 postnatal days
|
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有源比较器：Oral Vitamin D--800 IU/day
Cholecalciferol 800 IU given orally once per day
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200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours.
Other 3 doses will be placebo (sterile water).
Duration of 28 postnatal days
其他名称：
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours.
Duration of 28 postnatal days
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total number of days alive and off respiratory support in the first 28 days
大体时间：28 days
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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%).
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28 days
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Serum vitamin D concentration
大体时间：Day after birth 28
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Serum vitamin D levels determined by enzyme immunoassay obtained from whole blood (remnant sample or obtained during clinical blood draw)
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Day after birth 28
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of sepsis episodes treated with antibiotics for at least 5 days
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Number of episodes of culture proven or clinically suspected 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
|
|
Sepsis
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Culture proven or culture negative clinically treated course consistent with sepsis
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Need for supplemental oxygen at 36 weeks of corrected age (Physiologic definition)
大体时间：36 weeks gestational age corrected
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A physiologic oxygen challenge test will be administered to infants from 36.0 weeks gestation to 37.0 weeks gestation to determine a need for supplemental oxygen to keep saturation levels between 88-95%.
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36 weeks gestational age corrected
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Duration of mechanical ventilation after randomization
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Counted as number of days on which an infant is on mechanical ventilation for any part of a calendar day
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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
大体时间：28 days
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Counted as days alive without mechanical ventilation for any part of a day
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28 days
|
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Number of re-intubation events
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Counted as number of reintubations for purposes of respiratory support
|
Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
|
Death
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Cardiorespiratory failure
|
Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
|
Surgical necrotizing enterocolitis or intestinal perforation
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Radiographic documentation of pneumatosis or intestinal perforation or treatment course for clinical necrotizing enterocolitis per Bell's stage greater than 1.
|
Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
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25(OH)D concentrations >60ng/ml (150 nmol/L)
大体时间：14 postnatal (+/- 2 days)
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Vitamin D measurement per blood obtained either centrally or by heel stick.
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14 postnatal (+/- 2 days)
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25(OH)D concentrations >60ng/ml (150 nmol/L)
大体时间：28 days postnatal age (+/- 3 days)
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Vitamin D measurement per blood obtained either centrally or by heel stick.
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28 days postnatal age (+/- 3 days)
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Serum calcium level
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Serum calcium measurement per blood obtained either centrally or by heel stick, performed for clinical care.
High serum calcium level is greater than 3 mmol/l of total calcium or total calcium of >12 mg/dL, or ionized calcium >2 mml/L.
|
Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
|
Urine calcium level
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Calcium measurement per urine, random sampling.
High level (>95%tile) urine calcium to creatinine ratio is >3.8 mmol/mmol.
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
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Meningitis
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Culture proven or culture negative clinically treated course consistent with meningitis
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Death or Neurodevelopmental Impairment
大体时间：Birth to 22-26 months of age
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Birth to 22-26 months of age
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Ariel A. Salas, MD、University of Alabama at Birmingham
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
- Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年6月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2016年12月1日
研究注册日期
首次提交
2012年5月14日
首先提交符合 QC 标准的
2012年5月15日
首次发布 (估计)
2012年5月17日
研究记录更新
最后更新发布 (实际的)
2017年2月10日
上次提交的符合 QC 标准的更新
2017年2月8日
最后验证
2017年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.