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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02826824
Other study ID # 6268
Secondary ID
Status Recruiting
Phase N/A
First received June 16, 2016
Last updated May 19, 2017
Start date July 2016
Est. completion date September 2017

Study information

Verified date May 2017
Source University Hospital, Strasbourg, France
Contact Vincent LAUGEL, MD, PhD
Phone 33 (0)3.88.12.84.98
Email Vincent.LAUGEL@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The corpus callosum agenesis is an interesting malformation between 0.05% and 1.5% of the general population. This malformation is mostly diagnosed prenatally by ultrasound, usually at 22 weeks of gestation, and the use of prenatal advice is routinely offered to the couple.

Several studies in recent years have helped to define the determinants of prognosis for the unborn child suffers from agenesis of the corpus callosum, whether total or partial. These, mainly retrospective, demonstrated that the isolated nature of the deformity (defined as no other brain malformations and brain extra, absence of abnormal karyotype, maternal poisoning or viral seroconversion when pregnancy) is associated with favorable developments in terms of psychomotor development in 80% of cases Similar results were also found in prospective studies, while the associated nature of the defect seems most heavily encumber the prognosis as other malformation or syndrome associated with agenesis of the corpus callosum Although these recent data have already significantly influence prenatal counseling and outcome of pregnancy, questions about the future of the child carrying a prenatal diagnosis of agenesis of the corpus callosum are still valid.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 13 Years
Eligibility Inclusion criteria:

- Children born between January 2000 and January 2013 carrying a corpus callosum agenesis detected prenatally via the multidisciplinary center for prenatal diagnosis (CPDPN) of the Alsace-Lorraine region,

- Children whose holders of parental authority does not oppose the use of clinical data from their child for research purposes

Exclusion criteria:

- Children whose holders of parental authority are opposed to the use of clinical data from their child for research purposes

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service de Pediatrie 1 - Hopital de Hautepierre Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary questionnaire since January 2000 to january 2016
See also
  Status Clinical Trial Phase
Recruiting NCT05843110 - Decision-making Process of Couples Confronted With Prenatal Diagnosis of an Isolated CCA N/A