Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?

Premature Infant Clinical Trial

— SynchroPrema  

Official title:

Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03114644
• Other study ID #: PI2014_843_0010
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2016
• Est. completion date: January 17, 2024

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Jean-Marc GUILE, Dr
• Phone: +33322668295
• Email: jean-marc.guile[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 17, 2024
• Est. primary completion date: January 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Mother-Baby Synchrony
• Premature Birth
• Premature Infant

Intervention

Other:
• Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.
Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of cardio-respiratory synchronies and vagal tone		2 weeks