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

NCT02597088 | Unknown DMC

• 1 other identifier: 0156-15-SZMC
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Human Milk, Breast Milk

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (2)

• 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

Interventions

Laboratory studies of the effect of human milk handling using a rage surface area bottle (study device) OTHER

Using laboratory studies of the effect of storage and heating on expressed human milk, the investigators will compare milk handled in regular bottle and bottle warmer and milk handled using the study device (large surface area bottle)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Breastfeeding mothers. Up to 6 months PP. The milk will be mixed. The tested milk cannot be connected to specific donor.

You may qualify if:

• breastfeeding mother that can donate milk for the study

You may not qualify if:

• mothers that have milk supply issues

Sponsors & Collaborators

• Sharron Bransburg-Zabary Consulting services: lead
• Shaare Zedek Medical Center: collaborator

Study Officials

• Sharron Bransburg-Zabary, PhD

  Consulting services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharron Bransburg-Zabary, PhD

CONTACT

+972-544551342; sharron.zabary@gmail.com

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sharron Bransburg-Zabary, PhD IBCLC

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: November 4, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 4, 2015

Record last verified: 2015-09