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Human Milk Concentrating Device to Optimize Mother's Own Milk (NEOMOM)

2026年5月4日 更新者：Mother's Milk is Best

Noninferiority Evaluation of Human Milk Concentrating Device to Optimize Mother's Own Milk

This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants. The trial compares outcomes in infants fed mother's own milk (MOM) concentrated using the HMC device to those receiving standard of care feeding with MOM supplemented with cow's milk-based fortifiers or formula.

The primary objective is to determine whether infants receiving HMC-concentrated MOM achieve growth and mineral status that are non-inferior to standard of care, as measured by growth velocity through 28 days of life or hospital discharge and serum phosphate levels at 14 days of life.

Secondary objectives include assessment of clinical safety through evaluation of feeding tolerance, weight gain, and serum chemistries during the study period. The study will also evaluate the cost and resource utilization associated with feeding strategies by comparing preparation time, supply costs, total feeding costs, and overall neonatal intensive care unit (NICU) cost of care, including length of stay.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Preterm infants often require nutritional supplementation to support adequate growth and bone mineralization during hospitalization. Current standard of care commonly involves the addition of cow's milk-based fortifiers or formula to mother's own milk (MOM), which may introduce variability in feeding practices, added cost, and exposure to non-human milk components.

This study evaluates a human milk concentration (HMC) device designed to increase the nutrient density of MOM through passive water removal using forward osmosis. The device enables concentration of MOM without the addition of bovine-derived products and is intended to integrate into existing neonatal intensive care unit (NICU) feeding workflows.

The study is a randomized, controlled, non-inferiority trial conducted in preterm infants receiving enteral nutrition in the NICU. Participants are assigned to receive either MOM concentrated using the HMC device or standard of care feeding consisting of MOM with supplementation per institutional practice. Feeding preparation and administration are performed according to site-specific protocols.

Clinical assessments are conducted throughout the study period to evaluate infant growth, nutritional status, and overall clinical stability. Safety monitoring includes routine clinical evaluations and laboratory assessments consistent with standard NICU care. In addition, data are collected to assess resource utilization and costs associated with feeding preparation and overall care during hospitalization.

The goal of this study is to generate evidence on whether concentrating MOM using the HMC device can provide a clinically comparable alternative to standard supplementation practices while potentially reducing reliance on bovine-derived products and impacting healthcare resource utilization.

研究类型

介入性

注册 (估计的)

310

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。

学习联系方式

学习地点

  • 美国
    • Connecticut
      • New Haven、Connecticut、美国、06511
        • Yale University

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:

  • Birth at 32 0/7 to 34 5/7 weeks' gestational age, with a birthweight above 1500 grams and receiving MOM
  • Enteral feeding must be initiated within 48 hours post-birth and the infant must meet the NICU's clinical guidelines for feed fortification/supplementation.
  • Multiples are eligible and will be randomized to the same group since the intervention affects MOM preparation.

Exclusion Criteria:

  • Major congenital anomalies
  • Contraindication to receiving MOM
  • Feeds not started by 2 days post-birth
  • Fortification/supplementation not ordered by 5 days post-birth,
  • Inadequate MOM for concentration/fortification within 5 days post-birth
  • Expected transfer to another hospital
  • Expected hospital discharge within 14 days post-birth
  • Enrollment in another intervention study with an intervention that could affect infant growth or mineral status
  • Infant with contraindications for use of the HMC device

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：支持治疗
  • 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
实验性的：HMC-Concentrated MOM
Preterm infants receive enteral feedings of mother's own milk that has been concentrated using the HMC device to increase nutrient density without the addition of bovine-derived fortifiers.
设备：Human Milk Concentration Device
A sterile, single-use human milk concentration device used to passively remove water from mother's own milk prior to feeding, increasing nutrient density without the addition of bovine-derived fortifier.
有源比较器：Standard Fortified Feeding (MOM + Fortifier/Formula)
Preterm infants receive enteral feedings of mother's own milk supplemented with cow's milk-based fortifier or formula according to institutional standard of care.
其他：Standard of Care Fortified Feeding
Mother's own milk supplemented with cow's milk-based human milk fortifier and/or formula according to institutional standard of care.

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
Growth Velocity
大体时间：Birth to 28 days of life or hospital discharge, whichever occurs first
Average daily weight gain normalized to body weight in preterm infants receiving assigned feeding strategy.
Birth to 28 days of life or hospital discharge, whichever occurs first
Serum Phosphate Level
大体时间：14 days of life
Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.
14 days of life

次要结果测量

结果测量
措施说明
大体时间
Feeding Tolerance
大体时间：Up to 28 days of life or hospital discharge
Clinical assessment of feeding tolerance based on physical examination and incidence of feeding intolerance events during the study period.
Up to 28 days of life or hospital discharge
Weight Gain Monitoring
大体时间：Daily through 28 days of life or discharge
Serial assessment of infant weight to evaluate adequacy of growth during the study period.
Daily through 28 days of life or discharge
Feeding Preparation Cost
大体时间：Up to 28 days of life or discharge
Cost associated with preparation of feedings, including staff time and materials required for each feeding strategy.
Up to 28 days of life or discharge
Total Feeding Cost
大体时间：First 28 days of life or until discharge
Total cost of feeding over the study period, including milk, fortifier, formula, and preparation time.
First 28 days of life or until discharge
Length of Stay
大体时间：From birth to hospital discharge (up to 10 weeks)
Duration of hospitalization in the NICU.
From birth to hospital discharge (up to 10 weeks)
Total NICU cost of care
大体时间：From birth to hospital discharge (up to 10 weeks)
Total hospital costs incurred during NICU stay, including all resources utilized.
From birth to hospital discharge (up to 10 weeks)

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。

赞助

Mother's Milk is Best

合作者

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Yale University
Beth Israel Deaconess Medical Center
Weill Medical College of Cornell University

调查人员

  • 首席研究员：Sarah Taylor, MD、Yale University

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9月1日

初级完成 (估计的)

2027年3月14日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年5月8日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MMIB-NEOMOM-2000042290
  • R44HD110306 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

IPD Description:

De-identified individual participant data underlying the results reported in this study, including baseline characteristics and outcome measures, may be shared.

Access Criteria:

Data will be made available to qualified researchers upon reasonable request, subject to review and approval by the study sponsor. Access will require a data use agreement and must comply with applicable privacy and regulatory requirements.

IPD 共享时间框架

Beginning 6-12 months following publication and ending 3-5 years after publication.

IPD 共享访问标准

Access to de-identified individual participant data will be provided to qualified researchers upon reasonable request. Requests will be reviewed by the study sponsor to ensure the proposed use is scientifically and ethically appropriate and consistent with participant consent and institutional policies. Data sharing will require execution of a data use agreement and may require Institutional Review Board approval or exemption, as applicable. Data will be shared in a manner that protects participant privacy and confidential information.

IPD 共享支持信息类型

  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

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.

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