Infants With Agenesis of the Corpus Callosum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-26

Study Completion Date

2022-01-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Agenesis of the Corpus Callosum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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neuropsycological tests

Psychometric scales for infants at 3 years of age

Group Type EXPERIMENTAL

Psychometric scales for infants at 3 years of age

Intervention Type OTHER

WPPSI-III, VINELAND, CBCL, NEPSY

Interventions

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Psychometric scales for infants at 3 years of age

WPPSI-III, VINELAND, CBCL, NEPSY

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women from 28 weeks of gestation
* Complete agenesis of the corpus callosum
* Partial agenesis of the corpus callosum
* Abnormal corpus callosum (size, anatomy) As diagnosed by an expert ultrasound fetal brain examination.