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Completed

NCT Number: NCT02267161

Infants With Agenesis of the Corpus Callosum

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Armand Trousseau

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychometric scales for infants at 3 years of age

Other

WPPSI-III, VINELAND, CBCL, NEPSY

Primary outcomes

  1. WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire)

    Time frame: 3 years

    Neurodevelopment outcome

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Outcome of Infants With Prenatal Corpus Callosum Agenesis

Acronym: DACCI

Important dates

Study start
2015
Primary completion
2020
Study completion
2022
First posted
Oct 17, 2014
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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