AzTrials
AzTrials

Human Milk, Breast MilkNCT02597088

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

An observational study of Human Milk, Breast Milk, run by Sharron Bransburg-Zabary Consulting services.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Human Milk, Breast Milk
What is being tested?
Laboratory studies of the effect of human milk handling using a rage surface area bottle (study device)
How many people
20 participants
Where
No sites listed yet
Study dates
Nov 2015to Mar 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • breastfeeding mother that can donate milk for the study

Who cannot join

  • mothers that have milk supply issues

Trial locations and contacts

No sites are listed yet.

Sharron Bransburg-Zabary, PhD contact

+972-544551342

sharron.zabary@gmail.com

About this study

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.

Read the detailed description

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.

The experiment will last for 5 days. On the first day, one S-container and two C-containers will be taken out of the refrigerator and tested: the milk in each container will be warmed to feeding temperature in the container; it was then stirred gently and a sample of the warmed milk was obtained and stored at -20ºC until analyzed. This procedure was repeated on days 3 and 5 of the experiment.

The warming procedure used on the C-containers was as follows: the C-container will be warmed in standard electric water-based bottle warmer. Usually the warmer has three heating options; fast, medium, and slow. Investigators plan to test the fastest option on three of the six bottles and the slowest option on the remaining three bottles. The heating process will be terminated once the temperature of the heated milk reached 37ºC.

The warming procedure used on the S-containers was as follows: the S-container was placed in a bowl containing water at approximately 40ºC and gently moved in circles until the EHM reached 37 ºC.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (2)
  1. 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

    Measured: 3 months

  2. Faster warming time as in the study device compared with regular bottles.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionJan 2016 (estimated)
  4. Study completionMar 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02597088
Sponsor's protocol ID
0156-15-SZMC
Status last verified
Sep 2015
First submitted
26 Oct 2015
Last updated
4 Nov 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Human Milk, Breast Milk, run by Sharron Bransburg-Zabary Consulting services.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sharron Bransburg-Zabary, PhD (+972-544551342, sharron.zabary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015; AzTrials last refreshed its copy on 31 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in