Clinical Trial: Infants With Agenesis of the Corpus Callosum

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Outcome of Infants With Prenatal Corpus Callosum Agenesis

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 Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire) [ Time Frame: 3 years ]

Neurodevelopment outcome


Original Primary Outcome: Same as current

Current Secondary 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 ]


Original Secondary 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
  • IDE: Inventaire du Developpement de l'Enfant (behaviour) : self administered questionnaire [ Time Frame: 3 years ]
    Neurodevelopment outcome
  • Cerebral abnormalities [ Time Frame: up to 3 years ]


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: July 17, 2014
Date Started: July 2015
Date Completion: December 2021
Last Updated: July 19, 2016
Last Verified: July 2016