Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421772
Status:
UNKNOWN
Last Update Posted:
2007-01-12
First Post:
2007-01-11
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
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 148 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 121 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
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 121 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DGS 20060432 | None | None | None |
| CCPPRB 200608 | None | None | None |