Single-center Retrospective Study : Developmental Trajectories of Children Born Prematurely Before 32 Weeks Assessed With the Revised Brunet Lézine Scale at 1, 2 and 3 Years

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

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Other: Retrospective study

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • Chi Creteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children born prematurely before 32 weeks

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Analysis of duration of hospitalization	1,2 and 3 years
Evaluate the concordance of BLR scale at 5 years with the measurement scores (not validated) used by the Val de Marne perinatal network (and all the Ile de France perinatal networks) filed out during the same consultations	5 years
Evaluate the concordance of BLR scale at 5 years with the measurement scores (not validated) used by the Val de Marne perinatal network (and all the Ile de France perinatal networks) filed out during the same consultations	1,2 and 3 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Actual): June 17, 2024
• Study Completion (Actual): June 17, 2024

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: language; coordination; socialization; Developmental trajectories; Revised Brunet Lézine; movement and posture
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: PREMADEV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No