NCT02673385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

February 8, 2022

Status Verified

September 1, 2021

Enrollment Period

3.8 years

First QC Date

February 1, 2016

Last Update Submit

February 7, 2022

Conditions

Infant, Premature

Outcome Measures

Primary Outcomes (1)

  • Score GC (Global Confidence) of the MAPS scale (Mother Assessment Baby Scale)

    2 hours

Secondary Outcomes (1)

  • Scale "EVA Anxiety"

    1 hour

Study Arms (2)

Brazelton scale

Procurement across Brazelton scale

Other: Brazelton scale

No test

usual care

Interventions

Brazelton scaleOTHER
Brazelton scale

Eligibility Criteria

Age0 Weeks - 36 Weeks
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limoges Hospital

Limoges, 87 042, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 3, 2016

Study Start

March 15, 2016

Primary Completion

January 16, 2020

Study Completion

June 15, 2020

Last Updated

February 8, 2022

Record last verified: 2021-09

Locations

FR(1)