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Completed

NCT Number: NCT06731686

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

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Key information

Conditions

Premature Birth Behavior Communication Female Urogenital Diseases and Pregnancy Complications Language Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

2 month–32 month

Sex eligibility

All sexes

Study type

Observational

Primary location

CHI Créteil

Créteil, 94000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

retrospective study

Other

Collection of children's datas

Primary outcomes

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

    Time frame: 1, 2 and 3 years

Secondary outcomes

  1. 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.

    Time frame: 1,2 and 3 years

  2. Analysis of family socio-demographic data : level of education

    Time frame: 1,2 and 3 years

  3. Analysis of family socio-demographic data : age of parents

    Time frame: 1,2 and 3 years

  4. Analysis of birth data : term

    Time frame: 1, 2 and 3 years

  5. Analysis of birth data : weight

    Time frame: 1,2 and 3 years

  6. Analysis of duration of hospitalization

    Time frame: 1,2 and 3 years

  7. 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

    Time frame: 5 years

  8. 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

    Time frame: 1,2 and 3 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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