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

      • Lausanne, Switzerland, 1011
        • Clinic of neonatology - Avenue Pierre Decker 2

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
Subject delivering preterm baby
Subject delivering term baby

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantification of total protein concentration in human milk
Time Frame: from delivery, up to 4 months
from delivery, up to 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quantification of total lipids and carbohydrates
Time Frame: From delivery, up to 4 months
From delivery, up to 4 months
Determination of Calcium and Phosphorous content
Time Frame: From delivery, up to 4 months
From delivery, up to 4 months
Determination of peptide profiles and content
Time Frame: From delivery, up to 4 months
From delivery, up to 4 months
Determination of miRNA content
Time Frame: From delivery, up to 4 months
From delivery, up to 4 months

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

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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