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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04292522
Other study ID # RECHMPL19_0443-UF7969
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 27, 2020
Est. completion date December 31, 2021

Study information

Verified date February 2020
Source University Hospital, Montpellier
Contact Amaria Baghdadli, Professor
Phone 04 67 33 98 64
Email rech-clinique-autisme@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Autism Spectrum Disorder (ASD) is lifelong neurodevelopmental disorder that affect social communication and interaction and includes limited and repetitive patterns of behavior (DSM 5). In France, national guidelines about practices recommends early and specific interventions but care pathway are not well described for ASD children. The national health insurance information system record demographic data, medical condition, and reimbursed drug over 98% of the French population. In addition, the ELENA cohort is a large cohort of children with ASD followed for 6 years. Data collected include clinical characteristics of children (IQ, severity of ASD...) and parents (educational level, professional status...).

The first objective of this project is to identify patterns of care trajectories using data from ELENA cohort matched to data from national health insurance information system. Secondary objectives are to examine the links between patterns of care trajectories and clinical characteristics, social environment of autistic children.


Recruitment information / eligibility

Status Recruiting
Enrollment 903
Est. completion date December 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility Inclusion criteria:

- Included in ELENA Cohort

Exclusion criteria:

- Opposable to reuse data

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uh Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Care pathway Care pathway will be built from administrative database from birth to 2019 1 day
Primary Clinical characteristics Clinical, social and environmental data of children from ELENA cohort 1 day
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