Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
2018年6月14日 更新者：Colm Travers、University of Alabama at Birmingham
The primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day
研究概览
详细说明
The proposed trial is designed to test the primary hypothesis that in preterm infants weighing 1001-2500 grams at birth and who are less than or equal to 32 weeks gestation, feeding goals of 180-200 ml/kg/day will increase weight gain (g/k/day) from time of enrollment to discharge home or 36 weeks post-menstrual age (PMA)(whichever comes first) more than the commonly used feeding goal volume of 140-160 ml/kg/day (usual feeding goal).
This is a pilot study to determine the safety of increased volumes of feedings as opposed to fortification of feedings.
研究类型
介入性
注册 (实际的)
224
阶段
- 不适用
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
-
-
Alabama
-
Birmingham、Alabama、美国、35249
- University of Alabama at Birmingham
-
-
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天 至 1个月 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Inborn or outborn infants born at a gestational age of 32 weeks or less; Birthweight 1001-2500; Feeding volume of at least 120 ml/kg/day; Enrolled prior to 28 days of age and prior to exceeding 32 weeks
Exclusion Criteria:
- Hemodynamically significant patent ductus arteriosis; History of necrotizing enterocolitis Bell Stage II or greater; Known gastrointestinal or neurologic malformations; Prior or planned enrollment into the NICHD MILK Trial; Terminal illness or decision to withhold or limit support
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：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Higher Volume Feeding Goal
Infants randomized to this group will have higher volume feeding goals of 180-200 ml/kg/day.
|
feeding volume goal of 180-200 ml/kg/day
|
|
无干预：Usual Volume Feeding Goal
Infants randomized to this group will have feeding goals of 140-160 ml/kg/day.
|
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 |
|---|---|---|
|
Weight gain
大体时间：baseline to average 12 weeks of age
|
Average change in weight between baseline and 12 weeks
|
baseline to average 12 weeks of age
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mid arm circumference
大体时间：baseline to average 12 weeks of age
|
average change in mid arm circumference between baseline and 12 weeks
|
baseline to average 12 weeks of age
|
|
Length
大体时间：baseline to average 12 weeks of age
|
average change in length between baseline and 12 weeks
|
baseline to average 12 weeks of age
|
|
Head circumference
大体时间：baseline to average 12 weeks of age
|
average change in head circumference between baseline and 12 weeks
|
baseline to average 12 weeks of age
|
|
Caloric intake
大体时间：36 weeks
|
Average difference in weekly caloric intake between groups
|
36 weeks
|
|
Length of stay
大体时间：36 weeks or discharge
|
Days from study entry to discharge home
|
36 weeks or discharge
|
|
Rates of infants less than 10th percentile for weight
大体时间：36 weeks or discharge
|
Rates of infants less than 10th percentile for weight at study completion
|
36 weeks or discharge
|
|
Change in weight z score
大体时间：36 weeks or discharge
|
Change in weight z score from study entry to completion
|
36 weeks or discharge
|
|
Change in length z score
大体时间：36 weeks or discharge
|
Change in length z score from study entry to completion
|
36 weeks or discharge
|
|
Change in head circumference z score
大体时间：36 weeks or discharge
|
Change in head circumference z score from study entry to completion
|
36 weeks or discharge
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body fat composition
大体时间：36 weeks or discharge
|
Percentage of body fat composition
|
36 weeks or discharge
|
|
Rates of necrotizing enterocolitis (Bell Stage ≥ 2)
大体时间：36 weeks or discharge
|
Safety outcome: Rates of necrotizing enterocolitis (Bell Stage ≥ 2)
|
36 weeks or discharge
|
|
Rates of feeding intolerance
大体时间：36 weeks or discharge
|
Safety outcome: Rates of feeding intolerance defined as withholding feeds for > 24 hours due to gastrointestinal cause after study entry
|
36 weeks or discharge
|
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Rates of culture proven sepsis
大体时间：36 weeks or discharge
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Safety outcome: Rates of blood culture positive sepsis after study entry
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36 weeks or discharge
|
|
Duration of respiratory support
大体时间：36 weeks or discharge
|
Safety outcome: Duration of respiratory support (oxygen, continuous positive airway pressure/high flow nasal cannula/mechanical ventilation) after study entry
|
36 weeks or discharge
|
|
Rates of bronchopulmonary dysplasia
大体时间：36 weeks or discharge
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Safety outcome: Rates of bronchopulmonary dysplasia
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36 weeks or discharge
|
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Rates of moderate to large or symptomatic patent ductus arteriosus
大体时间：36 weeks or discharge
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Safety outcome: Rates of moderate to large or symptomatic patent ductus arteriosus after study entry
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36 weeks or discharge
|
|
Rates of adverse safety outcomes combined
大体时间：36 weeks or discharge
|
Safety outcome: Safety outcome: Rates of bronchopulmonary dysplasia, necrotizing enterocolitis ≥ stage 2, feeding intolerance, culture proven sepsis, patent ductus arteriosus after study entry
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36 weeks or discharge
|
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
- 首席研究员：Colm Travers, MD、University of Alabama at Birmingham
- 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
- Salas AA, Travers CP, Jerome ML, Chandler-Laney P, Carlo WA. Percent Body Fat Content Measured by Plethysmography in Infants Randomized to High- or Usual-Volume Feeding after Very Preterm Birth. J Pediatr. 2021 Mar;230:251-254.e3. doi: 10.1016/j.jpeds.2020.11.028. Epub 2020 Nov 25.
- Travers CP, Wang T, Salas AA, Schofield E, Dills M, Laney D, Yee A, Bhatia A, Winter L, Ambalavanan N, Carlo WA. Higher- or Usual-Volume Feedings in Infants Born Very Preterm: A Randomized Clinical Trial. J Pediatr. 2020 Sep;224:66-71.e1. doi: 10.1016/j.jpeds.2020.05.033. Epub 2020 May 25.
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
2015年1月1日
初级完成 (实际的)
2018年6月1日
研究完成 (实际的)
2018年6月1日
研究注册日期
首次提交
2014年12月1日
首先提交符合 QC 标准的
2015年2月24日
首次发布 (估计)
2015年3月3日
研究记录更新
最后更新发布 (实际的)
2018年6月18日
上次提交的符合 QC 标准的更新
2018年6月14日
最后验证
2018年6月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- UAB NEO 013
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.