Cerebral VentriculomegalyNCT00421772
Prospective Follow-up of a Multicentric Cohort of Children With Prenatal Discovery of Mild Isolated Cerebral Ventriculomegaly. Evaluation at 2 and 5 Years.
An observational study of Cerebral Ventriculomegaly, run by University Hospital, Angers at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 26 monthsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Ventriculomegaly
- How many people
- 245 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2007to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 26 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Claude BOUDERLIQUE, MD contact
France2 sites, 2 recruiting
- Recruiting
UH of Angers
Angers
Claude BOUDERLIQUE, MD, clbouderlique@chu-angers.fr
Claude BOUDERLIQUE, MD
- Not yet recruiting
UH of Nantes
Nantes
Norbert WINER, MD
Norbert WINER, MD
About this study
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 %.
Read more
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
- Keywords
- cerebral ventriculomegaly, prenatal diagnostic, neuropsychological outcome
- Medical subject headings
- Hydrocephalus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral VentriculomegalyStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 245 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, France
- Investigators
- Claude BOUDERLIQUE, MD, Principal investigator, UH of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421772
- Sponsor's protocol ID
- PHRC-05-03
- Other IDs
- DGS : 2006/0432, CCPPRB : 2006/08
- Status last verified
- Jan 2007
- First submitted
- 11 Jan 2007
- Last updated
- 12 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00421772
- Acronym / sponsor ID
- PHRC-05-03
- Conditions
- Cerebral Ventriculomegaly
- Keywords
- cerebral ventriculomegaly, prenatal diagnostic, neuropsychological outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 245 participants
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2007
- Study completion
- Jan 2007
- First posted
- 12 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 26 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude BOUDERLIQUE, MD contact
Claude BOUDERLIQUE, MD principal investigator
UH of Angers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Ventriculomegaly, run by University Hospital, Angers at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claude BOUDERLIQUE, MD (clbouderlique@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2007.