Infants With Agenesis of the Corpus Callosum (Dacci)
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|ClinicalTrials.gov Identifier: NCT02267161|
Recruitment Status : Active, not recruiting
First Posted : October 17, 2014
Last Update Posted : November 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Agenesis of the Corpus Callosum||Other: Psychometric scales for infants at 3 years of age||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire) [ Time Frame: 3 years ]Neurodevelopment outcome
- Vineland adaptative behaviour scales (motricity capacity) : questionnaire [ Time Frame: 3 years ]Neurodevelopment outcome
- Nepsy : developmental neuropsychological assessment (capacity of coordination) [ Time Frame: 3 years ]Neurodevelopment outcome
- CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire [ Time Frame: 3 years ]Neurodevelopment outcome
- Cerebral abnormalities [ Time Frame: up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267161
|Hôpital Armand Trousseau|
|Paris, France, 75012|
|Principal Investigator:||Jean-Marie Jouannic, MD, PhD||Assistance Publique - Hôpitaux de Paris|