Human MilkNCT01932619
The Influence of Storage Container and Defrost Process on Components in Breast Milk
An observational study of Human Milk, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Breast milk is best food for neonates and preterm infants. However many handling would be done if direct breastfeeding is not feasible, and it may result in nutrients change in human milk. We investigate the influence of storage in different containers and different thawing or heating methods on human milk nutrients. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Milk
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Apr 2013
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: healthy mothers lactating breast milk during first year of their babies
Who may be able to join
- healthy mothers lactating during first year of their babies and have sufficient milk to donate
Who cannot join
- mothers who have insufficient milk for their babies
- mothers have major disease or on specific diet or drug which would affect breast milk composition
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Neonatology, Department of Pediatrics, Taichung Veterans General Hospital
Taichung, 407
About this study
Breast milk is best food for neonates and preterm infants. However many handling would be done if direct breastfeeding is not feasible, and it may result in nutrients change in human milk. We investigate the influence of storage in different containers and different thawing or heating methods on human milk nutrients.
- Conditions
- Human Milk
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in nutrients of human milk after several processing
we measure the changes of nutrients, including fat, protein, lactose, energy, immunoglobulins, lactoferrin, leptin, and lysozyme in human milk after several processes, such as freezing, pasteurization, storage in different containers, thawing, and heat treatments.
Measured: within first year of milk expression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startJan 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MilkStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932619
- Sponsor's protocol ID
- C08178
- Status last verified
- Aug 2013
- First submitted
- 21 Aug 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Storage Container and Defrost Process on Components in Breast Milk
- ClinicalTrials.gov ID
- NCT01932619
- Acronym / sponsor ID
- C08178
- Conditions
- Human Milk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Aug 2013 (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.
Breast milk is best food for neonates and preterm infants. However many handling would be done if direct breastfeeding is not feasible, and it may result in nutrients change in human milk. We investigate the influence of storage in different containers and different thawing or heating methods on human milk nutrients.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy mothers lactating breast milk during first year of their babies
Key inclusion criteria (1 listed)
- healthy mothers lactating during first year of their babies and have sufficient milk to donate
Key exclusion criteria (2 listed)
- mothers who have insufficient milk for their babies
- mothers have major disease or on specific diet or drug which would affect breast milk composition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes in nutrients of human milk after several processing
Time frame: within first year of milk expression
we measure the changes of nutrients, including fat, protein, lactose, energy, immunoglobulins, lactoferrin, leptin, and lysozyme in human milk after several processes, such as freezing, pasteurization, storage in different containers, thawing, and heat treatments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
Related trials for Human Milk
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Protocol-driven Nutrition in Preterm Infants
Preterm Infants
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Guangzhou Preterm and Term Birth Cohort Study
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Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
Prematurity
Not yet recruiting
Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
Premature Birth, Infant, Premature
Not yet recruiting
Milk Free From A1-Type β-Casein With Human Milk Oligosaccharides on Gut Health, Immunity, Cognitive Development, and Temperament in Toddlers
Healthy Volunteers
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Milk, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 2 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: finished, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in nutrients of human milk after several processing (time frame: within first year of milk expression). 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 30 Aug 2013.