Infants With Agenesis of the Corpus Callosum

Agenesis of the Corpus Callosum Clinical Trial

— Dacci  

Official title:

Outcome of Infants With Prenatal Corpus Callosum Agenesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267161
• Other study ID #: ID-RCB: 2014-A00625-42
• Status: Completed
• Phase: N/A
• Start date: September 26, 2015
• Est. completion date: January 11, 2022

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 11, 2022
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agenesis of the Corpus Callosum
• Congenital Abnormalities

Intervention

Other:
• Psychometric scales for infants at 3 years of age
WPPSI-III, VINELAND, CBCL, NEPSY

Locations

Country	Name	City	State
France	Hôpital Armand Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire)	Neurodevelopment outcome	3 years
Secondary	Vineland adaptative behaviour scales (motricity capacity) : questionnaire	Neurodevelopment outcome	3 years
Secondary	Nepsy : developmental neuropsychological assessment (capacity of coordination)	Neurodevelopment outcome	3 years
Secondary	CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire	Neurodevelopment outcome	3 years
Secondary	Cerebral abnormalities		up to 3 years