Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-17 @ 10:13 AM
Study NCT ID:
NCT02267161
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2014-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infants With Agenesis of the Corpus Callosum
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Outcome of Infants With Prenatal Corpus Callosum Agenesis
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
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:
Dacci
Brief Summary:
The purpose of this study is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.
Detailed Description:
Agenesis of the corpus callosum is the most frequent brain malformation. This anomaly may be diagnosed by ultrasound screening. In half of these prenatal cases, the anomaly seems to be isolated. In this setting, there are no prospective data concerning the development of these children, preventing any clear information to be delivered to parents. Prenatal diagnostic centers therefore face extremely variable rates of termination of pregnancies (TOP), which can reach up to 80%.
This is a multicentric prospective interventional study whose primary objective is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.
Evaluation at three years will include Intellectual Quotient (IQ) quantification using the WPPSI-III, 3rd edition of Wechsler Preschool and Primary Scale of Intelligence and evaluation of intra-hemispheric coordination using the Vineland adaptative behaviour scale.
Secondary objectives will include:
* Circumstances leading to the prenatal diagnosis of agenesis of the corpus callosum
* Causes leading to termination of pregnancies
* Determination of criteria allowing to confirm that agenesis of the corpus callosum is isolated (family history, imagery, genetics)
These results could allow to determine the optimal prenatal management of such cases.
This is a multicentric prospective interventional study whose primary objective is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.
Evaluation at three years will include Intellectual Quotient (IQ) quantification using the WPPSI-III, 3rd edition of Wechsler Preschool and Primary Scale of Intelligence and evaluation of intra-hemispheric coordination using the Vineland adaptative behaviour scale.
Secondary objectives will include:
* Circumstances leading to the prenatal diagnosis of agenesis of the corpus callosum
* Causes leading to termination of pregnancies
* Determination of criteria allowing to confirm that agenesis of the corpus callosum is isolated (family history, imagery, genetics)
These results could allow to determine the optimal prenatal management of such cases.
Study Oversight
Has Oversight DMC:
False
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?: