Status:

COMPLETED

Prenatal Dex Study

Lead Sponsor:

Hospices Civils de Lyon

Conditions:

Congenital Adrenal Hyperplasia

Eligibility:

All Genders

6-15 years

Phase:

NA

Brief Summary

The classic form of 21-hydroxylase deficiency (prevalence 1/15,000) is the most common cause of congenital adrenal hyperplasia (CAH). This autosomic recessive disease is responsible for virilization o...

Eligibility Criteria

Inclusion

  • Groups D+1, D+2, D-1 and D-2
  • Male or female
  • Patient with Congenital Adrenal Hyperplasia or sibling of a CAH patient
  • Age: 6 to 15 years (at the time of inclusion)
  • The subject's legal representatives have understood the information note/informed consent form, obtained answers to all their questions and have given signed, written, informed consent
  • Subject with health insurance
  • Group D-3 (Schoolchildren)
  • Male or female
  • With no connection with Congenital Adrenal Hyperplasia
  • Age: 6 to 15 years (at the time of inclusion)
  • The subject's legal representatives have understood the information note/informed consent form, obtained answers to all their questions and have given signed, written, informed consent
  • Subject with health insurance

Exclusion

  • For all groups :
  • Patient/Subject with another genetic disease
  • Patient/Subject with known neuropsychology disease(s)
  • Patient/Subject whose mother has received another treatment during her pregnancy with possible known adverse events on the neuropsychological development of the child

Key Trial Info

Start Date :

October 4 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 13 2025

Estimated Enrollment :

354 Patients enrolled

Trial Details

Trial ID

NCT02795871

Start Date

October 4 2016

End Date

June 13 2025

Last Update

December 11 2025

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Service d'endocrinologie pédiatrique, CHU de Besançon

Besançon, France

2

Service d'endocrinologie pédiatrique, CHU de Bordeaux

Bordeaux, France

3

Groupement Hospitalier Est - Laboratoire d'endocrinologie moléculaire et maladies rares - Centre de biologie et de pathologie Est. 59 boulevard Pinel

Bron, France, 69677

4

Service d'endocrinologie pédiatrique, CHU de Grenoble

Grenoble, France