NCT06731686

Brief Summary

This study will assess professionals in the CHI Créteil neonatal department and the Val de Marne perinatal network to gain a better understanding of the developmental trajectories of children hospitalized at the CHI Créteil, with a view to optimizing their care in the long term

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

March 25, 2024

Last Update Submit

December 9, 2024

Conditions

Keywords

Developmental trajectoriesRevised Brunet Lézinemovement and posturelanguagesocializationcoordination

Outcome Measures

Primary Outcomes (1)

  • Overall DQ obtained on the BLR scale at 1, 2 and 3 years, collected by the psychomotor therapists at CHI Créteil.

    1, 2 and 3 years

Secondary Outcomes (8)

  • Analysis of the 4 sub-scores (movement and posture, language, socialization, coordination) obtained on the BLR scale at 1, 2 and 3 years, collected by the psychomotor therapists at CHI Créteil.

    1,2 and 3 years

  • Analysis of family socio-demographic data : level of education

    1,2 and 3 years

  • Analysis of family socio-demographic data : age of parents

    1,2 and 3 years

  • Analysis of birth data : term

    1, 2 and 3 years

  • Analysis of birth data : weight

    1,2 and 3 years

  • +3 more secondary outcomes

Interventions

Collection of children's datas

Eligibility Criteria

Age2 Months - 32 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children born prematurely before 32 weeks

You may qualify if:

  • Children born at CHI Créteil between 2012 and 2022, included in the Val de Marne perinatal network.
  • Children seen in pediatrician-psychomotor consultation with assessment by the BLR scale at 1 year AC.

You may not qualify if:

  • Children born with a term of birth ≥ 32 weeks + 1 day.
  • Child removed from the Val de Marne perinatal network monitoring from the age of 1 year AC: Death or parental decision.
  • Children presenting with cerebral palsy, blindness or deafness at the age of 1 year AC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHI Créteil

Créteil, 94000, France

Location

MeSH Terms

Conditions

Premature BirthLanguage

Interventions

Retrospective Studies

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Case-Control StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesCohort StudiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

December 12, 2024

Study Start

November 23, 2023

Primary Completion

June 17, 2024

Study Completion

June 17, 2024

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations