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 of the external genitalia in girls through androgen hypersecretion during fetal life. Since 1984, the Lyon Pediatric Endocrinology group has proposed prenatal dexamethasone (DEX) for all fetuses at risk of CAH With the aim of preventing fetal androgen hypersecretion in affected girls and avoiding poor long-term results from reconstructive surgery. Prenatal DEX was used in Europe and the USA but its use was recently suspended: in 2007, a Swedish study conducted on 26 children treated with DEX in utero for a short period of time reported cognitive impairments. These data were not confirmed by an American study on the short-term DEX use, which showed potential cognitive impairments in CAH children exposed to DEX for long periods of time. These confusing and controversial results have caused the scientific community to question its position and have resulted in the suspension of the use of prenatal DEX with drastic consequences for CAH girls (virilization; genital surgery etc.). In this context, an evaluation of neuropsychological development under in utero DEX is essential to validate its indication for use during the prenatal period. This study will evaluate outcomes using prospective cognitive and emotional assessments. It will first focus on the unaffected children previously treated in utero in order to assess the adverse effects of the drug. The study will then assess the children with CAH for whom DEX could have beneficial effects.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

354

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8.7 years study duration

First Submitted

Initial submission to the registry

May 25, 2016

Completed

16 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed

4 months until next milestone

Study Start

First participant enrolled

October 4, 2016

Completed

8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

8.7 years

First QC Date

May 25, 2016

Last Update Submit

December 4, 2025

Conditions

Congenital Adrenal Hyperplasia

Keywords

Congenital Adrenal HyperplasiaPrenatal treatmentDexamethasoneNeuropsychological assessmentCognitive development

Outcome Measures

Primary Outcomes (1)

Intelligence quotient
Wechsler Intelligence Scale for Children (WISC) is designed to measure human intelligence. WISC-IV includes: * Verbal Comprehension Index: measure of verbal concept formation. * Perceptual Reasoning Index: measure of non-verbal and fluid reasoning. * Working Memory Index: measure of working memory. * Processing Speed Index: measure of processing speed. Data measured: raw score (0 to 150), standard score (1 to 19), index (40 to 160). The four indexes of the intelligence quotient will be considered hierarchically as follows: first the Working Memory Index, then the Processing Speed Index, third the Perceptual Reasoning Index, fourth the Verbal Comprehension Index.
3 months

Secondary Outcomes (6)

Children Memory Scale (CMS)
3 months
Rey figure test
3 months
Revised - Child Measure of Anxiety Scale (R- CMAS) score
15 months
Mood Depressive Inventory for Children (MDI- C) score
15 months
Child Behavior Checklist (CBCL) score
15 months
+1 more secondary outcomes