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Prenatal steroid for CAH: safe for the brain? new study investigates

NCT ID NCT02795871

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study evaluates the long-term cognitive development of children who were exposed to dexamethasone (a steroid) while in the womb because they were at risk for congenital adrenal hyperplasia (CAH). The goal is to see if the drug causes any thinking or memory problems. Researchers will compare children with and without CAH who were or were not exposed to the drug, using IQ and memory tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexamethasone (a steroid given during pregnancy)
What this could lead to
If results show no harm, it could support the cautious use of prenatal dexamethasone to prevent genital virilization in girls with CAH, reducing the need for surgery.
What could go wrong
This is an observational follow-up study, not a new treatment trial. Previous studies have shown conflicting results on cognitive risks, and the small sample size may limit conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

354 people

The number who actually took part.

Started

Oct 2016

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 15 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Criteria: 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

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Conditions

The condition(s) this trial relates to.

congenital adrenal hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital adrenal hyperplasia

Contacts and locations

Locations

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

    Bron, 69677, France

  • Service d'endocrinologie pédiatrique, CHRU de Lille

    Lille, France

  • Service d'endocrinologie pédiatrique, CHU de Besançon

    Besançon, France

  • Service d'endocrinologie pédiatrique, CHU de Bordeaux

    Bordeaux, France

  • Service d'endocrinologie pédiatrique, CHU de Grenoble

    Grenoble, France

  • Service d'endocrinologie pédiatrique, CHU de Nantes

    Nantes, France

  • Service d'endocrinologie pédiatrique, CHU de Nice

    Nice, France

  • Service d'endocrinologie pédiatrique, CHU de Reims

    Reims, France

  • Service d'endocrinologie pédiatrique, Hopital de la Timone, APHM

    Marseille, France

  • Service d'endocrinologie pédiatrique, Hôpital Armand Trousseau, AP-HP

    Paris, France

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