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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)

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ClinicalTrials.gov Identifier: NCT02673385
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief 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. 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.


Condition or disease Intervention/treatment
Infant, Premature Other: Brazelton scale

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Study Start Date : March 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

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



Primary Outcome Measures :
  1. Score GC (Global Confidence) of the MAPS scale (Mother Assessment Baby Scale) [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Scale "EVA Anxiety" [ Time Frame: 1 hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Weeks   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mother-child dyads whose infants were born before 36 S.A.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673385


Contacts
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Contact: Ophelie KACZANOWSKI (+33) 5 55 05 68 63 ophelie.kaczanowski@chu-limoges.fr

Locations
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France
Limoges Hospital Recruiting
Limoges, France, 87 042
Contact: Ophélie KACZANOWSKI    +33 5 55 05 68 63    ophelie.kaczanowski@chu-limoges.fr   
Sponsors and Collaborators
University Hospital, Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02673385    
Other Study ID Numbers: I12022
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: September 2018
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications