Prospective Follow-up of a Multicentric Cohort of Children With Prenatal Discovery of Mild Isolated Cerebral Ventriculomegaly. Evaluation at 2 and 5 Years.
|ClinicalTrials.gov Identifier: NCT00421772|
Recruitment Status : Unknown
Verified January 2007 by University Hospital, Angers.
Recruitment status was: Recruiting
First Posted : January 12, 2007
Last Update Posted : January 12, 2007
|First Submitted Date||January 11, 2007|
|First Posted Date||January 12, 2007|
|Last Update Posted Date||January 12, 2007|
|Start Date||January 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Prospective Follow-up of a Multicentric Cohort of Children With Prenatal Discovery of Mild Isolated Cerebral Ventriculomegaly. Evaluation at 2 and 5 Years.|
|Official Title||Prospective Follow-up of a Multicentric Cohort of Children With Prenatal Discovery of Mild Isolated Cerebral Ventriculomegaly. Evaluation at 2 and 5 Years.|
Isolated uni or bilateral mild cerebral ventriculomegaly represents the most frequent “minor” cerebral anomalies discovered by antenatal echography. There are not French data making it possible to specify the incidence and the prevalence of this pathology and international data of the prevalence are very heterogeneous, going, according to the published series, of 1.48 to 22 per 1000 births.
The prognostic of ventriculomegaly remains dubious : the studies have small populations, are for the majority retrospectives with a short and often vague follow-up. The announced rate of after-effects varies between 0 and 48 %.
The objective of this study is to evaluate the neuropsychological development until the 5 years age of the children for whom a prenatally diagnosis of mild isolated ventriculomegaly was carried (absence of another cerebral or extra-cerebral anomaly in imagery and a negative aetiology). This prospective cohort will be compared with children for whom no neurological anomaly was prenatally detected.
The children diagnosed for an mild isolated cerebral ventriculomegaly will be identified by the investigators among medical files of the Centers of Prenatal Diagnosis (CPDPN) of the UH of Angers and the UH of Nantes. The patient inclusion will be done at the 2 years age after parental agreement, with a follow-up at 5 years. The control children will be included under the same conditions after having ensured of the normality of the echographies of 22 and 30 gestational weeks. The follow-up of these 2 cohorts will be based on the 2 years obligatory paediatric examination, and on the network “Naitre ensemble” set up in the Pays de la Loire Loire. In addition to the clinical routine examinations, standardized neuropsychological examinations will be done (Brunet Lezine Revised score at 2 years, NEPSY at 5 years and ASQ at 2 and 5 years).
This study will allow to compare the neuropsychological development at school age of the children diagnosed for a foetal mild, apparently isolated, cerebral ventriculomegaly from children not presenting any foetal anomaly, to evaluate the incidence of the mild isolated ventriculomegaly, to identify the predictive factors of the neuropsychological anomalies in the children diagnosed for ventriculomegaly and to compare (in the children diagnosed for ventriculomegaly), the neuropsychological development at the school age of the children having a ventricular atrium between 10 and 12 mm with those having a ventricular atrium between 12,1 and 15 mm.
This study will allow to define the neuropsychological morbidity of the foetal mild isolated cerebral ventriculomegaly and will allow to define the best clinical and educational follow up of these children and their family.
|Detailed Description||Not Provided|
|Study Design||Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status||Unknown status|
|Estimated Completion Date||January 2007|
|Primary Completion Date||Not Provided|
Inclusion criteria : case children
Inclusion criteria : control children
Non-inclusion criteria : case children
Non-inclusion criteria : control children
|Ages||22 Months to 26 Months (Child)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||France|
|Removed Location Countries|
|Other Study ID Numbers||PHRC-05-03
DGS : 2006/0432
CCPPRB : 2006/08
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||University Hospital, Angers|
|Collaborators||Ministry of Health, France|
|PRS Account||University Hospital, Angers|
|Verification Date||January 2007|