Breastfeeding Mothers of Infants HospitalizedPOOL-BMNCT02994823
The "Pooling" Expressed Breast Milk: A Method for Improving the Nutritional Intake of Premature Infants
An observational study of Breastfeeding Mothers of Infants Hospitalized, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Mothers of Infants Hospitalized
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Breastfeeding mothers of infants hospitalized
Who may be able to join
- 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
Who cannot join
- refusal
Trial locations and contacts
1 site in 1 country.
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
caloric value of breastmilk
The caloric value will be compared between the two groups (pooled expressed breastmilk versus individual expressed breastmilk)
Measured: at the end of each 24 hours collection from inclusion to the end of collection during 4 days
Secondary outcomes (1)
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.
Measured: at the end of each 24 hours collection from inclusion to the end of collection during 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionDec 2016
Why it stopped: prolonged device failure after just 10 participants and too long to resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding Mothers of Infants HospitalizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Murielle Dobrzynski, Study director, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994823
- Sponsor's protocol ID
- POOL-BM
- Acronym
- POOL-BM
- Status last verified
- Jan 2020
- First submitted
- 2 Sep 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Pooling" Expressed Breast Milk: A Method for Improving the Nutritional Intake of Premature Infants
- ClinicalTrials.gov ID
- NCT02994823
- Acronym / sponsor ID
- POOL-BM / POOL-BM
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: prolonged device failure after just 10 participants and too long to resume
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Breastfeeding mothers of infants hospitalized
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
bacterial contamination of breastmilk
Time frame: at the end of each 24 hours collection from inclusion to the end of collection during 4 days
Results and safety
The study was stopped early (reason given: prolonged device failure after just 10 participants and too long to resume). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murielle Dobrzynski study director
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding Mothers of Infants Hospitalized, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: prolonged device failure after just 10 participants and too long to resume). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caloric value of breastmilk (time frame: at the end of each 24 hours collection from inclusion to the end of collection during 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.