Breastfeeding ContinuationDOALNCT03938675
Early Use of Raw Milk and Breastfeeding Continuation
An observational study of Breastfeeding Continuation, run by Hospices Civils de Lyon.
Trial summary
BACKGROUND: Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Breastfeeding Continuation
- How many people
- 516 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2012to 1 Apr 2014
- 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 6 months
- All sexes
- Child
Study population: Neonates male or female admitted between April 2012 andJune 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.
Who may be able to join
- Eligible neonates were those admitted between April 2012 and June 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.
Who cannot join
- Neonates with parents not fluent in French were excluded.
About this study
Official title: Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study
BACKGROUND:
Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mother's own milk (MOM) in neonatal units.
Read more
OBJECTIVES:
This study aimed to describe the use of raw MOM in hospitalised neonates before day 7 (early use), and to investigate: (i) related factors, (ii) maternal satisfaction, and (iii) the association with breastfeeding continuation.
METHODS:
This prospective cohort included 516 neonates intended to be breastfed in 2 French neonatal units. Neonates receiving raw MOM before day 7 were compared to those who did not. The association between early use of MOM and breastfeeding continuation at hospital discharge, and up to 6 months later, was measured by logistic regression.
- Conditions
- Breastfeeding Continuation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Raw maternal own milk before day 7 | Without any intervention, investigators observed whether neonates received raw MOM during the first week of life. Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7. | |
| No Raw maternal own milk before day 7 | Without any intervention, investigators observed whether neonates received raw MOM during the first week of life. Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breastfeeding after hospital discharge
Breastfeeding was defined as the consumption of any mother's own milk (MOM), provided either directly at the breast or after having been expressed. Information on breastfeeding continuation was extracted from the electronic chart during the last 2 days preceding hospital discharge. It was classed as "exclusive" when all the fed milk was MOM, or "partial" when it was completed by other milk and/or food.
Measured: On Day 60 and Day 180 after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Apr 2012
- Primary completion1 Dec 2013
- Study completion1 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding ContinuationStudies 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
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Laborie, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938675
- Sponsor's protocol ID
- DOAL
- Acronym
- DOAL
- Status last verified
- May 2019
- First submitted
- 9 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03938675
- Acronym / sponsor ID
- DOAL / DOAL
- Conditions
- Breastfeeding Continuation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 1 Dec 2013 (actual)
- Study completion
- 1 Apr 2014 (actual)
- First posted
- 6 May 2019 (actual)
- 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.
BACKGROUND:
Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mother's own milk (MOM) in neonatal units.
OBJECTIVES:
This study aimed to describe the use of raw MOM in hospitalised neonates before day 7 (early use), and to investigate: (i) related factors, (ii) maternal satisfaction, and (iii) the association with breastfeeding continuation.
METHODS:
This prospective cohort included 516 neonates intended to be breastfed in 2 French neonatal units. Neonates receiving raw MOM before day 7 were compared to those who did not. The association between early use of MOM and breastfeeding continuation at hospital discharge, and up to 6 months later, was measured by logistic regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raw maternal own milk before day 7 | – | –Without any intervention, investigators observed whether neonates received raw MOM during the first week of life. Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7. |
| No Raw maternal own milk before day 7 | – | –Without any intervention, investigators observed whether neonates received raw MOM during the first week of life. Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Age groups
- Child
- Study population
- Neonates male or female admitted between April 2012 andJune 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.
Key inclusion criteria (1 listed)
- Eligible neonates were those admitted between April 2012 and June 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.
Key exclusion criteria (1 listed)
- Neonates with parents not fluent in French were excluded.
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
Change in breastfeeding after hospital discharge
Time frame: On Day 60 and Day 180 after hospital discharge
Breastfeeding was defined as the consumption of any mother's own milk (MOM), provided either directly at the breast or after having been expressed. Information on breastfeeding continuation was extracted from the electronic chart during the last 2 days preceding hospital discharge. It was classed as "exclusive" when all the fed milk was MOM, or "partial" when it was completed by other milk and/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 6 May 2019.
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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.
Sophie Laborie, MD principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding Continuation, run by Hospices Civils de Lyon.
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 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in breastfeeding after hospital discharge (time frame: On Day 60 and Day 180 after hospital discharge). 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 6 May 2019.