Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy

This study is currently recruiting participants.

Verified by Assistance Publique Hopitaux De Marseille, October 2008

Sponsored by:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00726206

Purpose

The general movement and the electroencephalogram analysis of the preterm have a high predictive value of the neuro-developmental outcome of the infants.

Condition	Intervention
Cerebral Palsy	Other: Electroencephalogram, recording the movements

MedlinePlus related topics: Cerebral Palsy Paralysis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy

Further study details as provided by Assistance Publique Hopitaux De Marseille:

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. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Recording of the movements Recording of the electroencephalogram	Other: Electroencephalogram, recording the movements Electroencephalogram, recording the movements of the child, RMI, Transfontanel Imaging

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.

Eligibility

Ages Eligible for Study:	up to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726206

Contacts

Contact: Catherine GIRE, MD

04 91 96 87 50

Locations

France
Service de Médecine Infantile et Néonatologie, CHU Nord	Recruiting
Marseille, France, 13915
Contact: Catherine GIRE, MD 04 91 96 87 50

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator:

Catherine GIRE, MD

Assistance Publique des Hopitaux de Marseille

More Information

Responsible Party:	Assistance Publique Hopitaux De Marseille ( Assistance Publique Hopitaux De Marseille )
Study ID Numbers:	2008-A00062 53, 2008-02
Study First Received:	July 30, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00726206
Health Authority:	France: Ministry of Health

Study placed in the following topic categories:

Paralysis
Cerebral Palsy
Brain Damage, Chronic

Central Nervous System Diseases
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009