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 (BRAZMAMAN)

February 7, 2022 updated by: University Hospital, Limoges

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87 042
        • Limoges hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Mother-child dyads whose infants were born before 36 S.A.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Brazelton scale
Procurement across Brazelton scale
Other: Brazelton scale
No test
usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score GC (Global Confidence) of the MAPS scale (Mother Assessment Baby Scale)
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Scale "EVA Anxiety"
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2016

Primary Completion (Actual)

January 16, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I12022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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