Breast-milk Enema Administration to Stimulate Passage of Meconium (BEAM)
2026年7月24日 更新者：Wake Forest University Health Sciences
Breast-Milk Enema Administration to Stimulate Meconium Passage in Preterm Infants
Lack of passage of meconium in preterm infants delays feeding advancement and may represent a risk factor for necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP).
Usual management of meconium impaction has included glycerin suppositories and normal saline enemas.
Various methods are used in routine neonatal care to promote meconium evacuation; however, there is no consensus on the agents used and the frequency of applications
研究概览
详细说明
Breast milk is a natural oil-in-water emulsion that can soften meconium, lubricate, and stimulate the intestinal wall, making it easier to excrete meconium.
The osmotic pressure of breast milk is a benign stimulus to the digestive tract of premature infants.
In addition, breast milk contains bioactive compounds that may positively influence gut motility and the microbiome and has been shown to decrease the incidence of NEC.
A small-volume rectal enemas using mother's own breast milk in preterm infants born at <28 weeks' gestation with delayed passage of meconium (>48 hours of life) are feasible and safe, and may be associated with earlier meconium passage and improved early feeding outcomes without increasing the risk of necrotizing enterocolitis (NEC) or other gastrointestinal complications.
研究类型
介入性
注册 (估计的)
20
阶段
- 阶段1
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。
学习联系方式
- 姓名：Monica C Gierbolini Collazo, MD
- 电话号码：787-239-6289
- 邮箱：monica.gierbolinicollazo@advocatehelth.org
学习地点
-
-
North Carolina
-
Winston-Salem、North Carolina、美国、27157
- Wake Forest University Health Sciences
-
接触：
- Monica C Gierbolini Collazo, MD
- 电话号码：787-239-6289
- 邮箱：monica.gierbolinicollazo@advocatehelth.org,
-
-
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
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
- Preterm infants born at >23 and <28 weeks' gestational age born at Atrium Health Wake Forest Baptist Hospital or transferred in the first 24 hours of life.
- postnatal age >48 hours, absence of spontaneous passage of meconium by >48 hours of life
- availability of mother's own milk
- written informed consent obtained from a parent or legal guardian.
Exclusion Criteria:
- Infants with Necrotizing Enterocolitis (NEC) ≥ stage II
- spontaneous intestinal perforation (SIP)
- gastrointestinal or anorectal malformations
- infants that have developed severe hemodynamic instability or sepsis with need for vasoactive drugs
- significant hematologic abnormalities such as neutropenia or thrombocytopenia.
- Infants will also be excluded in the absence of written informed consent from a parent or legal guardian.
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：breast milk
A small-volume rectal enema consisting of 5 mL/kg of fresh mother's own breast milk will be administered as a single dose, with the option for one repeat dose at 24 hours if clinically indicated.
The prescribed enema volume (5 mL/kg) will be calculated based on current weight and warmed to 37 °C using an approved breast milk warmer.
|
A small-volume rectal enema consisting of 5 mL/kg of fresh mother's own breast milk will be administered as a single dose, with the option for one repeat dose at 24 hours if clinically indicated.
|
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 |
|---|---|---|
|
Recruitment rate
大体时间：Day 1
|
Recruitment rate
|
Day 1
|
|
Protocol adherence rate
大体时间：Day 1
|
Protocol adherence rate
|
Day 1
|
|
Incidence of necrotizing enterocolitis (NEC)
大体时间：Day 14
|
Incidence of necrotizing enterocolitis (NEC)
|
Day 14
|
|
Incidence of culture proven sepsis
大体时间：Day 7
|
Incidence of culture proven sepsis
|
Day 7
|
|
Incidence of rectal or gastrointestinal injury
大体时间：Day 7
|
Incidence of rectal or gastrointestinal injury - Rectal trauma will be assessed clinically by the presence of bleeding, fissure, or other visible anorectal injury on physical examination.
|
Day 7
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to achieve full enteral feeds
大体时间：Day 14
|
Enteral feeds (enteral nutrition or tube feeding) times
|
Day 14
|
|
Duration of parenteral nutrition
大体时间：Day 14
|
Parenteral nutrition (PN) is a method of delivering essential nutrients directly into the bloodstream through an intravenous (IV) catheter.
|
Day 14
|
|
Time to first stool following intervention
大体时间：Day 7
|
Time to first stool following intervention
|
Day 7
|
|
Total length of hospital stay
大体时间：Day 120
|
Total length of hospital stay
|
Day 120
|
|
Number of central line days
大体时间：Day 120
|
Number of central line days
|
Day 120
|
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：Ricardo J Rodriquez, MD、Wake Forest University Health Sciences
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 (估计的)
2026年10月1日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年7月1日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月23日
研究记录更新
最后更新发布 (实际的)
2026年7月28日
上次提交的符合 QC 标准的更新
2026年7月24日
最后验证
2026年6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.