Back to resultsCorrelation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroencephalogram, recording the movements
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Children been born between 15/01/08 and 15/01/10
- children whose term is lower than 28 weeks of amenorrhoea
Exclusion Criteria:
- Born child superior to 28 weeks of amenorrhoea
- presenting child a genic syndrome, an evolutionary neurological disease, a pathology malformative
Sites / Locations
- Service de Médecine Infantile et Néonatologie, CHU Nord
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Recording of the movements Recording of the electroencephalogram
Outcomes
Primary Outcome Measures
To prove the predictive value of the " Deltas Brushes " triggered by hand or foot stimulation in correlation with the general movement analysis in the cerebral palsy diagnosis.
Secondary Outcome Measures
To prove that the general movement of the preterm increases the predictive value the actual monitoring of the preterm's in the diagnosis of cerebral palsy.
Full Information
NCT ID
NCT00726206
First Posted
July 30, 2008
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT00726206
Brief Title
Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy
Official Title
Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The general movement and the electroencephalogram analysis of the preterm have a high predictive value of the neuro-developmental outcome of the infants.
Detailed Description
Compare the technical and the predictive characteristics of the qualitative analysis of the spontaneous motility with those of actual exams of reference diagnosis : magnetic resonance imaging, electroencephalogram and transfontanellar imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Recording of the movements Recording of the electroencephalogram
Intervention Type
Other
Intervention Name(s)
Electroencephalogram, recording the movements
Intervention Description
Electroencephalogram, recording the movements of the child, RMI, Transfontanel Imaging
Primary Outcome Measure Information:
Title
To prove the predictive value of the " Deltas Brushes " triggered by hand or foot stimulation in correlation with the general movement analysis in the cerebral palsy diagnosis.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
To prove that the general movement of the preterm increases the predictive value the actual monitoring of the preterm's in the diagnosis of cerebral palsy.
Time Frame
36 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children been born between 15/01/08 and 15/01/10
children whose term is lower than 28 weeks of amenorrhoea
Exclusion Criteria:
Born child superior to 28 weeks of amenorrhoea
presenting child a genic syndrome, an evolutionary neurological disease, a pathology malformative
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine GIRE, MD
Organizational Affiliation
Assistance Publique des Hopitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Médecine Infantile et Néonatologie, CHU Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
12. IPD Sharing Statement
Learn more about this trial
Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy
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