Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02994823
Other study ID # POOL-BM
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 2015
Est. completion date December 2016

Study information

Verified date January 2020
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date December 2016
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Breastfeeding Mothers of Infants Hospitalized

Locations

Country Name City State
France CHUR de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary caloric value of breastmilk 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 bacterial contamination of breastmilk 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