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Infants With Agenesis of the Corpus Callosum (Dacci)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02267161
Recruitment Status : Active, not recruiting
First Posted : October 17, 2014
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE July 17, 2014
First Posted Date  ICMJE October 17, 2014
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE September 26, 2015
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire) [ Time Frame: 3 years ]
Neurodevelopment outcome
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 1, 2015)
  • 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 Measures  ICMJE
 (submitted: October 14, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Infants With Agenesis of the Corpus Callosum
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Agenesis of the Corpus Callosum
Intervention  ICMJE Other: Psychometric scales for infants at 3 years of age
WPPSI-III, VINELAND, CBCL, NEPSY
Study Arms  ICMJE Experimental: neuropsycological tests
Psychometric scales for infants at 3 years of age
Intervention: Other: Psychometric scales for infants at 3 years of age
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 25, 2019)
72
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2014)
60
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02267161
Other Study ID Numbers  ICMJE ID-RCB: 2014-A00625-42
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Marie Jouannic, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP