- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02052245
Pre/Term Milk Profiling
September 12, 2014 updated by: Nestlé
Longitudinal Composition of Human Milk for Term and Preterm Infants
This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
61
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lausanne, Switzerland, 1011
- Clinic of neonatology - Avenue Pierre Decker 2
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Mothers who will breast feed their baby
Description
Inclusion Criteria:
- Having obtained informed consent
- Group 1 (term delivery): Gestational age between 37 0/7 and not above 41 6/7 weeks
- Group 2 (preterm delivery): Gestational age between 28 0/7 and 32 6/7 weeks
- Age: Mother ≥ 18 years old
- Partial or total breast feeding
- Having a freezer compartment at home (approx. -18°C)
- Good understanding of the French language
Exclusion Criteria:
- Suffering from diabetes (type I or II) before pregnancy
- Alcohol consumption: more than 1 standard drink / day
- Drug addicted
- Subject who cannot be expected to comply with the study procedures.
- Currently participating in an interventional therapeutic clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Subject delivering preterm baby
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Subject delivering term baby
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Quantification of total protein concentration in human milk
Time Frame: from delivery, up to 4 months
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from delivery, up to 4 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quantification of total lipids and carbohydrates
Time Frame: From delivery, up to 4 months
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From delivery, up to 4 months
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Determination of Calcium and Phosphorous content
Time Frame: From delivery, up to 4 months
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From delivery, up to 4 months
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Determination of peptide profiles and content
Time Frame: From delivery, up to 4 months
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From delivery, up to 4 months
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Determination of miRNA content
Time Frame: From delivery, up to 4 months
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From delivery, up to 4 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
October 8, 2013
First Submitted That Met QC Criteria
January 30, 2014
First Posted (Estimate)
February 3, 2014
Study Record Updates
Last Update Posted (Estimate)
September 15, 2014
Last Update Submitted That Met QC Criteria
September 12, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11.39.NRC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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