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.
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.
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.
- Conditions
- Human Milk, Breast Milk
- 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.
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)
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
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.
- First posted4 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Milk, Breast MilkStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sharron Bransburg-Zabary Consulting services
- Sponsor type
- University, hospital or other
- Collaborators
- Shaare Zedek Medical Center
- Responsible party
- Principal investigator, Sharron Bransburg-Zabary, Sharron Bransburg-Zabary Consulting services
- Investigators
- Sharron Bransburg-Zabary, PhD, Principal investigator, Consulting services
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Methods for Enhance Human Milk Presentation During Storage and Warming
- ClinicalTrials.gov ID
- NCT02597088
- Acronym / sponsor ID
- 0156-15-SZMC
- Conditions
- Human Milk, Breast Milk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sharron Bransburg-Zabary Consulting servicesUniversity, hospital or other
- Collaborators
- Shaare Zedek Medical Center
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Breastfeeding mothers. Up to 6 months PP. The milk will be mixed. The tested milk cannot be connected to specific donor.
Key inclusion criteria (1 listed)
- breastfeeding mother that can donate milk for the study
Key exclusion criteria (1 listed)
- mothers that have milk supply issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory studies of the effect of human milk handling using a rage surface area bottle (study device)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) | Other | – |
Primary outcome
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
2 secondary outcomes
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
Time frame: 3 months
Faster warming time as in the study device compared with regular bottles.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
Related trials for Human Milk, Breast Milk
Not yet recruiting
Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants
Premature, Preterm Infant Health
Active, not recruitingObservational study
Human Milk and Its Effect on Infant's Metabolism and Infant Gut Microbiome
Breast Milk Collection, Human Milk/Breastfeeding
Not yet recruitingObservational study
Breastmilk and the Link to Overweight/Obesity and Maternal Diet in the Mother-breastmilk-child Triad
Body Weight, Obesity & Overweight
RecruitingObservational study
Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants
Infant Body Composition and Metabolism, Metabolism
Not yet recruiting
the Effect of Virtual Reality Glasses on Women Who Milk Their Babies by Milking
Human Milk, Breast Milk
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharron Bransburg-Zabary, PhD principal investigator
Consulting services
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.