Infants With Agenesis of the Corpus Callosum (Dacci)

• ClinicalTrials.gov Identifier: NCT02267161
• Recruitment Status: Active, not recruiting
• First Posted: October 17, 2014
• Last Update Posted: October 28, 2019
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

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.

Condition or disease	Intervention/treatment	Phase
Agenesis of the Corpus Callosum	Other: Psychometric scales for infants at 3 years of age	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Outcome of Infants With Prenatal Corpus Callosum Agenesis
• Actual Study Start Date: September 26, 2015
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: neuropsycological tests; Psychometric scales for infants at 3 years of age	Other: Psychometric scales for infants at 3 years of age; WPPSI-III, VINELAND, CBCL, NEPSY

Outcome Measures

Primary Outcome Measures :

1. WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire) [ Time Frame: 3 years ]
   Neurodevelopment outcome

Secondary Outcome Measures :

1. Vineland adaptative behaviour scales (motricity capacity) : questionnaire [ Time Frame: 3 years ]
   Neurodevelopment outcome
2. Nepsy : developmental neuropsychological assessment (capacity of coordination) [ Time Frame: 3 years ]
   Neurodevelopment outcome
3. CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire [ Time Frame: 3 years ]
   Neurodevelopment outcome
4. Cerebral abnormalities [ Time Frame: up to 3 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Hôpital Armand Trousseau

Paris, France, 75012

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Jean-Marie Jouannic, MD, PhD; Assistance Publique - Hôpitaux de Paris

More Information

Publications:

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. Review.

Moutard ML, Kieffer V, Feingold J, Lewin F, Baron JM, Adamsbaum C, Gélot 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.

Moutard ML, Kieffer V, Feingold J, Kieffer F, Lewin F, Adamsbaum C, Gélot A, Campistol I Plana J, van Bogaert P, André M, Ponsot G. Agenesis of corpus callosum: prenatal diagnosis and prognosis. Childs Nerv Syst. 2003 Aug;19(7-8):471-6. Epub 2003 Jul 4.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT02267161
• Other Study ID Numbers: ID-RCB: 2014-A00625-42
• First Posted: October 17, 2014
• Last Update Posted: October 28, 2019
• Last Verified: October 2019

Keywords provided by Assistance Publique - Hôpitaux de Paris:

agenesis; corpus callosum; prenatal diagnosis

Additional relevant MeSH terms:

Agenesis of Corpus Callosum; Congenital Abnormalities; Nervous System Malformations; Nervous System Diseases; Pathological Conditions, Anatomical