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临床试验/NCT02597088
NCT02597088Unknown不适用

Development of Methods for Enhance Human Milk Presentation During Storage and Warming

Sharron Bransburg-Zabary Consulting services0 个研究点目标入组 20 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
主要终点
Measurements of higher concentration of thermolabile proteins or/and higher activity level of thermolabile enzymes, in expressed human milk that was handled using the study device as compared to regular baby bottles

研究概览

简要总结

Human milk (HM) is more than a food complex; in addition to micronutrients and human-coded bioactive complexes it also includes many antioxidants, antibacterial, prebiotics, probiotics, immune-boosting constituents, and many other bioactive components. Some of these components may deteriorate during storage, and expressed EHM starts deteriorating as soon as it leaves the breast. Nevertheless, whenever nursing at the breast or feeding of fresh EHM is not possible, feeding of stored EHM is considered the next best thing to feeding at the breast. Efficient heat transfer abilities affect both heating and cooling processes.

In this study the investigators wish to test a new device that permits rapid heating and cooling processes. The investigators plan to measure some thermolabile constituents of HM in order to determine whether they might be protected by a more gentle warming process. The investigators plan to collect milk from mother, to mix it and to test the effect of storage and heating.

This experiment is design to test the feasibility and the efficiency of the device.

详细描述

Exclusive breastfeeding is the normative model against which all alternative feeding methods must be measured with regard to infant growth, health, development, and all other short and long-term outcomes.

Recommendations for what is "safe" storage of Expressed HM have been developed, mainly for use by HM banks, but what constitutes optimal storage is less evident. Optimal handling of Expressed HM (EHM) should include proper storage as well as proper heating and thawing prior to use, in order to reduce damage to its nutritional and bioactive components.

Efficient heat transfer abilities affect both heating and cooling processes. In a previous work , the investigators showed that overheating of EHM is highly probable when using commercially available electrical water-based bottle warmers, even if the manufacturer's recommendations are followed . Besides warming process, EHM stability can also be affected by container composition and shape, storage temperature and whether or not sterilization was effected prior to storage. Following our previous study, the investigators hypothesized that a non-standard storage and warming process may increase EHM preservation. The investigators therefore designed a novel device with larger surface area and narrower milk width in order to minimize temperature gradients within the milk volume.

The investigators plan to store and heat HM in regular baby bottle and in our device and test thermolabile properties of HM, such as certain proteins and microbiological cultures, to asses if the new device can indeed protect the milk.

In order to obtain EHM from mothers, the investigators will collected freshly pumped milk The pumped milk will be pooled into a single container. A milk samples will be taken to define the reference values then it will equally divide into three study containers and into six control containers (C-container, regular baby bottles). After filling, all containers will be placed in a dark refrigerator at the temperature of 4ºC.

研究设计

研究类型
Observational

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • breastfeeding mother that can donate milk for the study

排除标准

  • mothers that have milk supply issues

结局指标

主要结局

Measurements of higher concentration of thermolabile proteins or/and higher activity level of thermolabile enzymes, in expressed human milk that was handled using the study device as compared to regular baby bottles

时间窗: 3 months

次要结局

  • Less commensal bacterial growth measured using microbiological counts in the expressed milk that was handled using the study device as compared to regular baby bottles(3 months)
  • Faster warming time as in the study device compared with regular bottles.(3 months)

研究者

发起方
Sharron Bransburg-Zabary Consulting services
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharron Bransburg-Zabary

Sharron Bransburg-Zabary, PhD IBCLC

Sharron Bransburg-Zabary Consulting services

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