Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
2017年11月25日 更新者：Danhua Wang、Peking Union Medical College Hospital
This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.
研究概览
详细说明
A total of 60 premature infants who will be randomized to receive either a standard fortification regimen (n=30) or an adjustable fortification regimen (n=30).
The adjustable fortification regimen encompasses increasing / decreasing the amount of fortifier and adding supplemental protein guided by periodic determinations of the protein concentration in human milk (PCHM), body weight and blood urea nitrogen (BUN).
Growth rate, tolerance of enteral feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition and NICU stays will be measured and compared between groups.
研究类型
介入性
注册 (实际的)
51
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
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Beijing
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Beijing、Beijing、中国、100730
- Peking Union Medical College Hospital
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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周 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:
- Less than 34 weeks gestational age at birth
- Birth weight within 800-1800 grams
- Exclusively or mostly breastfed (greater than 80% if the feeding volume)
- Tolerated enteral feedings of 60 ml/kg/d
- Remain in the Neonatal Intensive Care Unit at least 14 days prior to hospital discharge,remain in the Neonatal Intensive Care Unit at least 10 days after enrollment
- Signed Informed Consent
Exclusion Criteria:
- Small for gestational age
- Infants currently receiving ventilation therapy
- Major congenital malformations
- Suspected or documented systemic or congenital infections
- Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth
- Severe intraventricular hemorrhage (greater than grade II) or periventricular leukomalacia
- Suspected or documented maternal substance abuse
- Infants currently receiving glucocorticoids or infants who have received glucocorticoids within the past 28 days
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Standard Fortification
receive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study
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Then fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen
其他名称：
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实验性的：Adjustable fortification
encompasses increasing/decreasing the amount of human milk fortifier(HMF) and adding supplemental protein guided by periodic determinations of the protein concentration of human milk (PCHM), body weight, blood urea nitrogen(BUN)
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Then fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen
其他名称：
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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 |
|---|---|---|
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Time to reach 100kcal/kg/d of enteral nutrition
大体时间：participants will be followed until discharge, an expected average of 2 weeks
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Days to reach 100kcal/kg/d of enteral nutrition
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participants will be followed until discharge, an expected average of 2 weeks
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The weight gain velocity during hospitalization
大体时间：participants will be followed until discharge, an expected average of 2 weeks
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The weight gain velocity(g/kg/d)
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participants will be followed until discharge, an expected average of 2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The protein and energy ratio of enteral nutrition each week after enrollment
大体时间：participants will be followed until discharge, an expected average of 2 weeks
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The protein and energy ratio(g/100kcal)
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participants will be followed until discharge, an expected average of 2 weeks
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Time to reach 2000g of body weight
大体时间：participants will be followed until discharge, an expected average of 2 weeks
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Days to reach 2000g of body weight
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participants will be followed until discharge, an expected average of 2 weeks
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metabolic indicators after enrollment, including BUN,prealbumin, albumin
大体时间：participants will be followed until discharge, an expected average of 2 weeks
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BUN(mmol/L), prealbumin(mg/L), albumin(g/L)
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participants will be followed until discharge, an expected average of 2 weeks
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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
- 首席研究员：Danhua Wang, Professor、Peking Union Medical College Hospital
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 (实际的)
2012年8月1日
初级完成 (实际的)
2017年8月1日
研究完成 (实际的)
2017年8月1日
研究注册日期
首次提交
2012年11月5日
首先提交符合 QC 标准的
2012年11月16日
首次发布 (估计)
2012年11月22日
研究记录更新
最后更新发布 (实际的)
2017年11月28日
上次提交的符合 QC 标准的更新
2017年11月25日
最后验证
2017年11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.
human milk fortifier的临床试验
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University of PittsburghNational Institute of Nursing Research (NINR)完全的
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Arash Asher, MDVoxxLife招聘中
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Imperial College LondonCambridge University Hospitals NHS Foundation Trust; University of Edinburgh; University of Manchester 和其他合作者终止
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University of ConnecticutUnited States Department of Defense; AMP Human; Park City, UT完全的
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University of ConnecticutUnited States Department of Defense; AMP Human; Park City, UT完全的