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Infants With Agenesis of the Corpus Callosum (Dacci)

Primary Purpose

Agenesis of the Corpus Callosum

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychometric scales for infants at 3 years of age
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Agenesis of the Corpus Callosum focused on measuring agenesis, corpus callosum, prenatal diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Armand Trousseau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

neuropsycological tests

Arm Description

Psychometric scales for infants at 3 years of age

Outcomes

Primary Outcome Measures

WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire)
Neurodevelopment outcome

Secondary Outcome Measures

Vineland adaptative behaviour scales (motricity capacity) : questionnaire
Neurodevelopment outcome
Nepsy : developmental neuropsychological assessment (capacity of coordination)
Neurodevelopment outcome
CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire
Neurodevelopment outcome
Cerebral abnormalities

Full Information

First Posted
July 17, 2014
Last Updated
September 26, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02267161
Brief Title
Infants With Agenesis of the Corpus Callosum
Acronym
Dacci
Official Title
Outcome of Infants With Prenatal Corpus Callosum Agenesis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2015 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
January 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agenesis of the Corpus Callosum
Keywords
agenesis, corpus callosum, prenatal diagnosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
neuropsycological tests
Arm Type
Experimental
Arm Description
Psychometric scales for infants at 3 years of age
Intervention Type
Other
Intervention Name(s)
Psychometric scales for infants at 3 years of age
Intervention Description
WPPSI-III, VINELAND, CBCL, NEPSY
Primary Outcome Measure Information:
Title
WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire)
Description
Neurodevelopment outcome
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Vineland adaptative behaviour scales (motricity capacity) : questionnaire
Description
Neurodevelopment outcome
Time Frame
3 years
Title
Nepsy : developmental neuropsychological assessment (capacity of coordination)
Description
Neurodevelopment outcome
Time Frame
3 years
Title
CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire
Description
Neurodevelopment outcome
Time Frame
3 years
Title
Cerebral abnormalities
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marie Jouannic, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Armand Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22284958
Citation
Sotiriadis A, Makrydimas G. Neurodevelopment after prenatal diagnosis of isolated agenesis of the corpus callosum: an integrative review. Am J Obstet Gynecol. 2012 Apr;206(4):337.e1-5. doi: 10.1016/j.ajog.2011.12.024. Epub 2011 Dec 27.
Results Reference
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PubMed Identifier
22430728
Citation
Moutard ML, Kieffer V, Feingold J, Lewin F, Baron JM, Adamsbaum C, Gelot A, Isapof A, Kieffer F, de Villemeur TB. Isolated corpus callosum agenesis: a ten-year follow-up after prenatal diagnosis (how are the children without corpus callosum at 10 years of age?). Prenat Diagn. 2012 Mar;32(3):277-83. doi: 10.1002/pd.3824.
Results Reference
background
PubMed Identifier
12845459
Citation
Moutard ML, Kieffer V, Feingold J, Kieffer F, Lewin F, Adamsbaum C, Gelot A, Campistol I Plana J, van Bogaert P, Andre M, Ponsot G. Agenesis of corpus callosum: prenatal diagnosis and prognosis. Childs Nerv Syst. 2003 Aug;19(7-8):471-6. doi: 10.1007/s00381-003-0781-6. Epub 2003 Jul 4.
Results Reference
background

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Infants With Agenesis of the Corpus Callosum

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