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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00726206
Other study ID # 2008-A00062 53
Secondary ID 2008-02
Status Completed
Phase N/A
First received July 30, 2008
Last updated August 27, 2014
Start date July 2008
Est. completion date September 2010

Study information

Verified date August 2014
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date September 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 23 Months
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Electroencephalogram, recording the movements
Electroencephalogram, recording the movements of the child, RMI, Transfontanel Imaging

Locations

Country Name City State
France Service de Médecine Infantile et Néonatologie, CHU Nord Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 36 months No
Secondary 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. 36 months No
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