Prospective Follow-up of a Multicentric Cohort of Children With Prenatal Discovery of Mild Isolated Cerebral Ventriculomegaly. Evaluation at 2 and 5 Years.

NCT ID: NCT00421772

Last Updated: 2007-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 245 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-01-31

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 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.

Conditions

Cerebral Ventriculomegaly

Study Design

• Observational Model Type: DEFINED_POPULATION
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Diagnosis of foetal mild isolated cerebral ventriculomegaly at 32 gestational weeks by the Centers of Prenatal Diagnosis (CPDPN) of the UH of Angers and the UH of Nantes
• Age : 22 to 26 months

• Written informed consent
• Negative diagnostic of foetal cerebral ventriculomegaly at the prenatal echography made at 22 gestational weeks
• Age : 22 to 26 months

• Preterm birth (< 37 weeks of gestation)
• APGAR ≤ 3 at 5 minutes after birth
• Serious prenatal pathology with neurologic aspect requing intensive care
• postnatal hydrocephalus
• Diagnostic of a eurological pathology at birth
• Diagnostic d'une pathologie neurologique associée à la naissance

• Preterm birth (< 37 weeks of gestation)
• APGAR ≤ 3 at 5 minutes after birth
• Serious prenatal pathology with neurologic aspect requing intensive care
• postnatal hydrocephalus
• Diagnostic of a neurological pathology at birth
• Cerebral or extracerebral anomaly at the prenatal echographies
• Chromosomal anomaly discovered after birth

• Minimum Eligible Age: 22 Months
• Maximum Eligible Age: 26 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Claude BOUDERLIQUE, MD

Role: PRINCIPAL_INVESTIGATOR

UH of Angers

Locations

UH of Angers

Angers, , France

Site Status: RECRUITING

UH of Nantes

Nantes, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Claude BOUDERLIQUE, MD

Role: CONTACT

clbouderlique@chu-angers.fr

Facility Contacts

Claude BOUDERLIQUE, MD

Role: primary

clbouderlique@chu-angers.fr

Norbert WINER, MD

Role: primary

Other Identifiers

DGS : 2006/0432

Identifier Type: -

Identifier Source: secondary_id

CCPPRB : 2006/08

Identifier Type: -

Identifier Source: secondary_id

PHRC-05-03

Identifier Type: -

Identifier Source: org_study_id