Cerebral Ventriculomegaly Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 245 |
| Est. completion date | January 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 22 Months to 26 Months |
| Eligibility |
Inclusion criteria : case children - 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 Inclusion criteria : control children - Written informed consent - Negative diagnostic of foetal cerebral ventriculomegaly at the prenatal echography made at 22 gestational weeks - Age : 22 to 26 months Non-inclusion criteria : case children - 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 Non-inclusion criteria : control children - 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 |
Observational Model: Defined Population, Time Perspective: Longitudinal
| Country | Name | City | State |
|---|---|---|---|
| France | UH of Angers | Angers | |
| France | UH of Nantes | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Angers | Ministry of Health, France |
France,