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Trial record 2 of 13 for:    "Corpus callosum agenesis"

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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


Locations
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France
Hôpital Armand Trousseau
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-Marie Jouannic, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02267161     History of Changes
Other Study ID Numbers: ID-RCB: 2014-A00625-42
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: April 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
agenesis
corpus callosum
prenatal diagnosis

Additional relevant MeSH terms:
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Congenital Abnormalities
Agenesis of Corpus Callosum
Nervous System Malformations
Nervous System Diseases
Pathological Conditions, Anatomical