Infants With Agenesis of the Corpus Callosum

Not Applicable

Completed

• Conditions: Agenesis of the Corpus Callosum
• Interventions: Other: Psychometric scales for infants at 3 years of age

• Registration Number: NCT02267161
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-17
• Study Start: 2015-09-26
• Primary Completion: 2020-10-01
• Study Completion: 2022-01-11
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Exclusion Criteria

• age < 18 years old
• women who do not understand french
• women not covered by the French social security system
• refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neuropsycological tests	Psychometric scales for infants at 3 years of age	Psychometric scales for infants at 3 years of age

Primary Outcome Measures

Name	Time	Method
WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire)	3 years	Neurodevelopment outcome

Secondary Outcome Measures

Name	Time	Method
Nepsy : developmental neuropsychological assessment (capacity of coordination)	3 years	Neurodevelopment outcome
Vineland adaptative behaviour scales (motricity capacity) : questionnaire	3 years	Neurodevelopment outcome
CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire	3 years	Neurodevelopment outcome
Cerebral abnormalities	up to 3 years

Trial Locations

Locations (1)

Hôpital Armand Trousseau; 🇫🇷 Paris, France