The "Pooling" Expressed Breast Milk: A Method for Improving the Nutritional Intake of Premature Infants (POOL-BM)

January 14, 2020 updated by: University Hospital, Brest
The investigators compared a pooled mother's expressed breastmilk for 24 hours with individual pump session collection of milk to provide a more consistent caloric product without increasing bacterial contamination.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

10

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

  • France
      • Brest, France, 29609
        • CHUR de Brest

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Breastfeeding mothers of infants hospitalized

Description

Inclusion Criteria:

  • Mother of newborn hospitalized in intensive care unit
  • Mother using a breast pump in the unit and / or at home
  • Mother respected the rules of handling and transport breastmilk
  • No opposition mother

Exclusion Criteria:

  • refusal

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
caloric value of breastmilk
Time Frame: at the end of each 24 hours collection from inclusion to the end of collection during 4 days
The caloric value will be compared between the two groups (pooled expressed breastmilk versus individual expressed breastmilk)
at the end of each 24 hours collection from inclusion to the end of collection during 4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bacterial contamination of breastmilk
Time Frame: at the end of each 24 hours collection from inclusion to the end of collection during 4 days
The bacterial contamination of breastmilk will be compared between the two groups with the value for colony-forming units per milliliter (cfu/mL) after plating on sheep blood agar and Chapman's agar.
at the end of each 24 hours collection from inclusion to the end of collection during 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Study Director: Murielle Dobrzynski, CHRU de Brest

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 (ACTUAL)

June 1, 2015

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (ESTIMATE)

December 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • POOL-BM

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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