NCT00726206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 7, 2026

Status Verified

August 1, 2014

Enrollment Period

2.1 years

First QC Date

July 30, 2008

Last Update Submit

May 4, 2026

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (1)

1

OTHER

Recording of the movements Recording of the electroencephalogram

Other: Electroencephalogram, recording the movements

Interventions

Electroencephalogram, recording the movementsOTHER

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

1

Eligibility Criteria

AgeUp to 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children been born between 15/01/08 and 15/01/10
  • children whose term is lower than 28 weeks of amenorrhoea

You may not qualify if:

  • Born child superior to 28 weeks of amenorrhoea
  • presenting child a genic syndrome, an evolutionary neurological disease, a pathology malformative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine Infantile et Néonatologie, CHU Nord

Marseille, 13915, France

Location

Related Publications (1)

  • Zahed-Cheikh M, Brevaut-Malaty V, Busuttil M, Monnier AS, Roussel M, Gire C. Comparative analysis of perinatal and postnatal factors, and general movement in extremely preterm infants. Brain Dev. 2011 Sep;33(8):656-65. doi: 10.1016/j.braindev.2010.10.023. Epub 2011 Jan 26.

    PMID: 21273017RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Catherine GIRE, MD

    Assistance Publique des Hopitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2008

First Posted

July 31, 2008

Study Start

July 1, 2008

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

May 7, 2026

Record last verified: 2014-08

Locations

FR(1)