Breastfeeding Mothers of Infants Hospitalized Clinical Trial
— POOL-BMNCT 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 |
Verified date | January 2020 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHUR de Brest | Brest |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
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 |