Clinical trial NCT02267161: Infants With Agenesis of the Corpus Callosum
Official title: Outcome of Infants With Prenatal Corpus Callosum Agenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Agenesis of the Corpus Callosum
Keywords: agenesis
corpus callosum
prenatal diagnosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire)
timeFrame: 3 years
Secondary outcomes:
measure: Vineland adaptative behaviour scales (motricity capacity) : questionnaire
timeFrame: 3 years
measure: Nepsy : developmental neuropsychological assessment (capacity of coordination)
timeFrame: 3 years
measure: CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire
timeFrame: 3 years
measure: Cerebral abnormalities
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Armand Trousseau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Marie Jouannic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.