BreastfeedingDOALNCT02819193
Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates
An observational study of Breastfeeding, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Despite the importance of breast milk for sick or preterm neonates, there is currently no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate the association between early use of raw MOM… Read more about this study
- Who is it for?
- Ages Up to 42 weeks
- Conditions the study is for
- Breastfeeding
- What is being tested?
- raw mother's own milk
- How many people
- 665 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Dec 2013
- 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 Up to 42 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Neonates from two French participating centres.
Who may be able to join
- Admitted neonates between April 2012 and June 2013 are eligible if they are intended to be breastfeed and hospitalized ≥7 days
Who cannot join
- Neonates with parents not fluent in French.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Réanimation Néonatale et Néonatologie, Hôpital Femme Mère Enfant, 32 Avenue Doyen Jean Lépine
Bron, 69500
About this study
Despite the importance of breast milk for sick or preterm neonates, there is currently no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate the association between early use of raw MOM and breastfeeding continuation at discharge and up to 6 months later.
- Conditions
- Breastfeeding
- Being tested
- raw mother's own milk
- Keywords
- Breastfeeding, mother's milk, breast milk, raw milk, neonate, Neonatal intensive care unit (NICU)
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raw mother's own milkOther
Infants receive mother's own milk before day 7.
| Study group | Role | What they receive |
|---|---|---|
| exposed group : early raw mother's own milk | The use of raw MOM is considered as "early" when it begins before day 7. Receives: Other: raw mother's own milk | |
| unexposed group : no use of raw mother's own milk | Neonates who receive, or not, raw MOM before day 7. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal breastfeeding
Maternal breastfeeding is defined as the consumption of any MOM. It is classed as "exclusive" when all the fed milk will be MOM or "partial" when it will be completed by other milk or food.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startApr 2012
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 665 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Fischer Fumeaux, MD, Principal investigator, Service de Réanimation Néonatale et Néonatologie, Hôpital Femme Mère Enfant, Bron, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819193
- Sponsor's protocol ID
- 69HCL16_0379
- Acronym
- DOAL
- Status last verified
- Jun 2016
- First submitted
- 28 Jun 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates
- ClinicalTrials.gov ID
- NCT02819193
- Acronym / sponsor ID
- DOAL / 69HCL16_0379
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, mother's milk, breast milk, raw milk, neonate, Neonatal intensive care unit (NICU)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 665 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Jun 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.
Despite the importance of breast milk for sick or preterm neonates, there is currently no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate the association between early use of raw MOM and breastfeeding continuation at discharge and up to 6 months later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed group : early raw mother's own milk | – | Other: raw mother's own milkThe use of raw MOM is considered as "early" when it begins before day 7. |
| unexposed group : no use of raw mother's own milk | – | –Neonates who receive, or not, raw MOM before day 7. |
Who may qualify
- Ages
- Up to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates from two French participating centres.
Key inclusion criteria (1 listed)
- Admitted neonates between April 2012 and June 2013 are eligible if they are intended to be breastfeed and hospitalized ≥7 days
Key exclusion criteria (1 listed)
- Neonates with parents not fluent in French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| raw mother's own milkInfants receive mother's own milk before day 7. | Other | exposed group : early raw mother's own milk |
Primary outcome
Maternal breastfeeding
Time frame: up to 6 months
Maternal breastfeeding is defined as the consumption of any MOM. It is classed as "exclusive" when all the fed milk will be MOM or "partial" when it will be completed by other milk or food.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
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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.
Céline Fischer Fumeaux, MD principal investigator
Service de Réanimation Néonatale et Néonatologie, Hôpital Femme Mère Enfant, Bron, France
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, run by Hospices Civils de Lyon 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 1 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: finished, as of the sponsor's last update on 30 Jun 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maternal breastfeeding (time frame: up to 6 months). 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 30 Jun 2016.