Back to resultsReading Stories to Premature Babies Reinforces Mother-baby Synchronies? (SynchroPrema)
Primary Purpose
Premature Infant, Mother-Baby Synchrony
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.
Sponsored by
About this trial
This is an interventional other trial for Premature Infant
Eligibility Criteria
Inclusion Criteria:
- A premature birth between 27 and 37 SA
- At the time of the transfers, the latter must be hospitalized in intensive care and extubated
Exclusion Criteria:
For the baby:
- an unstable medical condition
- Serious somatic complications
- genetic or neurological diseases
- a twin.
For the mother:
- an impossibility to understand and speak the French language
- a mental or cognitive pathology
- an addiction to alcohol or other psychoactive substances
- persons under guardianship or curatorship or deprived of their liberty by a judicial or administrative decision
Sites / Locations
- CHU Amiens PicardieRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Babies born prematurely between 27 and 37 SA
Arm Description
Outcomes
Primary Outcome Measures
Analysis of cardio-respiratory synchronies and vagal tone
Secondary Outcome Measures
Full Information
NCT ID
NCT03114644
First Posted
April 5, 2017
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03114644
Brief Title
Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?
Acronym
SynchroPrema
Official Title
Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2016 (Actual)
Primary Completion Date
January 17, 2024 (Anticipated)
Study Completion Date
January 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby.
Detailed Description
Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby. In this study, the investigator proposes to focus on premature births (before 37 years) because prematurity disrupts the synchronization of these mother-baby communication. For several years, reading of stories and nursery rhymes has been used by the liaison child psychiatry team in the neonatal medicine and pediatric intensive care unit of the University Hospital of Amiens, as a therapeutic mediation tool allowing And support for parent-child interactions. Thus, it is desirable to explore the impact of reading stories and rhymes on mother-baby synchronies. The study is innovative because it simultaneously explores several fields: physiological, neuroendocrine, cognitive and psychic. A pilot study carried out in 2013 showed the feasibility of this exploration in the three protagonists of the interaction: mother, preterm baby and reader.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant, Mother-Baby Synchrony
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Babies born prematurely between 27 and 37 SA
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.
Intervention Description
Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.
Primary Outcome Measure Information:
Title
Analysis of cardio-respiratory synchronies and vagal tone
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A premature birth between 27 and 37 SA
At the time of the transfers, the latter must be hospitalized in intensive care and extubated
Exclusion Criteria:
For the baby:
an unstable medical condition
Serious somatic complications
genetic or neurological diseases
a twin.
For the mother:
an impossibility to understand and speak the French language
a mental or cognitive pathology
an addiction to alcohol or other psychoactive substances
persons under guardianship or curatorship or deprived of their liberty by a judicial or administrative decision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Marc GUILE, Dr
Phone
+33322668295
Email
jean-marc.guile@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc GUILE, Dr
Phone
+33322668295
Email
jean-marc.guile@chu-amiens.fr
12. IPD Sharing Statement
Learn more about this trial
Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?
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