Preterm MilkNCT02052245
Pre/Term Milk Profiling
An observational study of Preterm Milk and Term Milk, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Milk, Term Milk
- How many people
- 61 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2013to Jul 2014
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mothers who will breast feed their baby
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic of neonatology - Avenue Pierre Decker 2
Lausanne, 1011
About this study
Official title: 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
- Conditions
- Preterm Milk, Term Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subject delivering preterm baby | Not described | |
| Subject delivering term baby | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of total protein concentration in human milk
Measured: from delivery, up to 4 months
Secondary outcomes (4)
Quantification of total lipids and carbohydrates
Measured: From delivery, up to 4 months
Determination of Calcium and Phosphorous content
Measured: From delivery, up to 4 months
Determination of peptide profiles and content
Measured: From delivery, up to 4 months
Determination of miRNA content
Measured: From delivery, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052245
- Sponsor's protocol ID
- 11.39.NRC
- Status last verified
- Sep 2014
- First submitted
- 8 Oct 2013
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia-Rodenas CL, De Castro CA, Jenni R, Thakkar SK, Beauport L, Tolsa JF, Fischer-Fumeaux CJ, Affolter M. Temporal changes of major protein concentrations in preterm and term human milk. A prospective cohort study. Clin Nutr. 2019 Aug;38(4):1844-1852. doi: 10.1016/j.clnu.2018.07.016. Epub 2018 Jul 26.
PubMed 30093147
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Composition of Human Milk for Term and Preterm Infants
- ClinicalTrials.gov ID
- NCT02052245
- Acronym / sponsor ID
- 11.39.NRC
- Conditions
- Preterm Milk, Term Milk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Feb 2014 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subject delivering preterm baby | – | – |
| Subject delivering term baby | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mothers who will breast feed their baby
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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
Quantification of total protein concentration in human milk
Time frame: from delivery, up to 4 months
4 secondary outcomes
Quantification of total lipids and carbohydrates
Time frame: From delivery, up to 4 months
Determination of Calcium and Phosphorous content
Time frame: From delivery, up to 4 months
Determination of peptide profiles and content
Time frame: From delivery, up to 4 months
Determination of miRNA content
Time frame: From delivery, up to 4 months
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 15 Sep 2014.
- Derived from this study: PubMed 30093147Garcia-Rodenas CL, De Castro CA, Jenni R, Thakkar SK, Beauport L, Tolsa JF, Fischer-Fumeaux CJ, Affolter M. Temporal changes of major protein concentrations in preterm and term human milk. A prospective cohort study. Clin Nutr. 2019 Aug;38(4):1844-1852. doi: 10.1016/j.clnu.2018.07.016. Epub 2018 Jul 26.
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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 Preterm Milk and Term Milk, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 7 inclusion and 5 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 15 Sep 2014. 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 Switzerland. 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?
Quantification of total protein concentration in human milk (time frame: from delivery, up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02052245, which also lists 1 linked publication.
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 15 Sep 2014.