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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00726206
First received: July 30, 2008
Last updated: January 26, 2010
Last verified: January 2010
  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

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

Resource links provided by NLM:


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

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00726206     History of Changes
Other Study ID Numbers: 2008-A00062 53, 2008-02
Study First Received: July 30, 2008
Last Updated: January 26, 2010
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014