NCT03114644

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2024

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

8 years

First QC Date

April 5, 2017

Last Update Submit

March 21, 2023

Conditions

Premature InfantMother-Baby Synchrony

Outcome Measures

Primary Outcomes (1)

  • Analysis of cardio-respiratory synchronies and vagal tone

    2 weeks

Study Arms (1)

Babies born prematurely between 27 and 37 SA

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

Interventions

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

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

Babies born prematurely between 27 and 37 SA

Eligibility Criteria

Age25 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A premature birth between 27 and 37 SA
  • At the time of the transfers, the latter must be hospitalized in intensive care and extubated

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jean-Marc GUILE, Dr

CONTACT

+33322668295jean-marc.guile@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 14, 2017

Study Start

January 17, 2016

Primary Completion

January 17, 2024

Study Completion

January 17, 2024

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

FR(1)