Infant, PrematureBRAZMAMANNCT02673385
Study of the Impact of Administering t the Scale of Brazelton on the Mother's Confidence in Her Newborn Born Premature at the Approach of Returning Home
An observational study of Infant, Premature, run by University Hospital, Limoges at 1 site in France.
Trial summary
In France, the last national perinatal survey show that 6.6% of live births are premature. For these infants, transfer in Neonatology sector may result in mother-child separation can last several weeks or months. Read more about this study
- Who is it for?
- Ages 0 to 36 weeks, men only
- Conditions the study is for
- Infant, Premature
- What is being tested?
- Brazelton scale
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2016to 15 Jun 2020
- 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 0 to 36 weeks
- Men only
- No healthy volunteers
- Child
Study population: Mother-child dyads whose infants were born before 36 S.A.
Who may be able to join
- Mother: over the age of 18, affiliated to a health social security.
- Newborn: born to a term of less than 36 S.A., hospitalized in neonatology, said leaving in three days.
Who cannot join
- Mother :
- Legally protected
- Inability to understanding and monitoring of the protocol's terms (not master the French language, intellectual impairment, psychotic disorder ...)
- Who have had a premature child born.
- New born :
- Opposition of one of the holders of parental authority to the award of the Brazelton Scale
- Having withdrawal syndromes or malformation syndromes requiring oxygen therapy, gastrostomy or nasogastric tube
- Twins and more.
Trial locations and contacts
1 site in 1 country.
About this study
In France, the last national perinatal survey show that 6.6% of live births are premature. For these infants, transfer in Neonatology sector may result in mother-child separation can last several weeks or months. This hospital can complicate the implementation of the attachment process that allows parents to recognize their children as their own, to gain confidence in their abilities to deal with them and establish a relationship with him.
A study of mothers of premature shows the interest of the Brazelton scale to help them identify the skills their child and adjust their own behavior.
- Conditions
- Infant, Premature
- Being tested
- Brazelton scale
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brazelton scaleOther
| Study group | Role | What they receive |
|---|---|---|
| Brazelton scale | Procurement across Brazelton scale Receives: Other: Brazelton scale | |
| No test | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score GC (Global Confidence) of the MAPS scale (Mother Assessment Baby Scale)
Measured: 2 hours
Secondary outcomes (1)
Scale "EVA Anxiety"
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start15 Mar 2016
- Primary completion16 Jan 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673385
- Sponsor's protocol ID
- I12022
- Acronym
- BRAZMAMAN
- Status last verified
- Sep 2021
- First submitted
- 1 Feb 2016
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Administering t the Scale of Brazelton on the Mother's Confidence in Her Newborn Born Premature at the Approach of Returning Home
- ClinicalTrials.gov ID
- NCT02673385
- Acronym / sponsor ID
- BRAZMAMAN / I12022
- Conditions
- Infant, Premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 3 Feb 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.
In France, the last national perinatal survey show that 6.6% of live births are premature. For these infants, transfer in Neonatology sector may result in mother-child separation can last several weeks or months. This hospital can complicate the implementation of the attachment process that allows parents to recognize their children as their own, to gain confidence in their abilities to deal with them and establish a relationship with him.
A study of mothers of premature shows the interest of the Brazelton scale to help them identify the skills their child and adjust their own behavior.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brazelton scale | – | Other: Brazelton scaleProcurement across Brazelton scale |
| No test | – | –usual care |
Who may qualify
- Ages
- 0 to 36 weeks
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Mother-child dyads whose infants were born before 36 S.A.
Key inclusion criteria (2 listed)
- Mother: over the age of 18, affiliated to a health social security.
- Newborn: born to a term of less than 36 S.A., hospitalized in neonatology, said leaving in three days.
Key exclusion criteria (8 listed)
- Legally protected
- Inability to understanding and monitoring of the protocol's terms (not master the French language, intellectual impairment, psychotic disorder ...)
- Who have had a premature child born.
- Opposition of one of the holders of parental authority to the award of the Brazelton Scale
- Having withdrawal syndromes or malformation syndromes requiring oxygen therapy, gastrostomy or nasogastric tube
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 |
|---|---|---|
| Brazelton scale | Other | Brazelton scale |
Primary outcome
Score GC (Global Confidence) of the MAPS scale (Mother Assessment Baby Scale)
Time frame: 2 hours
1 secondary outcome
Scale "EVA Anxiety"
Time frame: 1 hour
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 8 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infant, Premature, run by University Hospital, Limoges 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 2 inclusion and 8 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 8 Feb 2022. 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?
Score GC (Global Confidence) of the MAPS scale (Mother Assessment Baby Scale) (time frame: 2 hours). 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 8 Feb 2022.