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

Infant, Premature Clinical Trial

— BRAZMAMAN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673385
• Other study ID #: I12022
• Status: Completed
• Start date: March 15, 2016
• Est. completion date: June 15, 2020

Study information

• Verified date: September 2021
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 15, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 36 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Infant, Premature
• Premature Birth

Intervention

Other:
• Brazelton scale

Locations

Country	Name	City	State
France	Limoges Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score GC (Global Confidence) of the MAPS scale (Mother Assessment Baby Scale)		2 hours
Secondary	Scale "EVA Anxiety"		1 hour