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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01043822
Other study ID # UF8481
Secondary ID
Status Recruiting
Phase N/A
First received January 6, 2010
Last updated October 28, 2010
Start date December 2009
Est. completion date July 2011

Study information

Verified date October 2010
Source University Hospital, Montpellier
Contact Amaria BAGHDADLI, Pr
Phone 04 67 33 63 83
Email a-baghdadli@chu-montpellier.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

The purpose of this study is to describe facial, behavioral and physiologic (heart rate) reactivity of children with autism aged 3 to 6 years old, during a painful stimulation (venepuncture). Children will be videotaped before, during and after a venepuncture. Each recording will be rated with the FACS (Facial Action Coding System) and the NCCPC (Non Communicating Children's Pain Checklist).


Description:

Children with autism will be matched with children with mental retardation and children without developmental disorder. Matching will be established according the developmental age of children with autism.


Recruitment information / eligibility

Status Recruiting
Enrollment 138
Est. completion date July 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Months to 6 Years
Eligibility Inclusion Criteria:

Group Autism:

- Child aged 3 to 6 years old

- Diagnosis of autistic disorder established according a pluridisciplinary staff (ICD-10 criteria, Vineland scales, ADOS, etc.)

- Admitted to children's neuropediatrics or genetics department for a venepuncture

Control group mental retardation:

- Child aged 3 to 6 years old .

- Diagnosis of mental retardation established according a pluridisciplinary staff (ICD-10 criteria, Vineland scales, ADOS, etc.)

- Admitted to neuropediatric or genetic department for a venepuncture

Control group without developmental disorder :

- Child aged 18 months to 5 years old.

- Admitted to pediatrics department for a venepuncture

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Locations

Country Name City State
France Montpellier University Hospital Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

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