Pre/Term Milk Profiling

NCT ID: NCT02052245

Last Updated: 2014-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Preterm Milk Term Milk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subject delivering preterm baby

No interventions assigned to this group

Subject delivering term baby

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinic of neonatology - Avenue Pierre Decker 2

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 30093147 (View on PubMed)

Other Identifiers

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11.39.NRC

Identifier Type: -

Identifier Source: org_study_id

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