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NCT Number: NCT02795871

Prenatal Dex Study

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.

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Key information

Conditions

Congenital Adrenal Hyperplasia Adrenal Gland Diseases Adrenal Hyperplasia, Congenital Adrenogenital Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Steroid Metabolism, Inborn Errors Urogenital Abnormalities Urogenital Diseases

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'endocrinologie pédiatrique, CHU de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Neuropsychological and cognitive assessment

Behavioral

Primary outcomes

  1. Intelligence quotient

    Time frame: 3 months

    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.

Secondary outcomes

  1. Children Memory Scale (CMS)

    Time frame: 3 months

    Neurocognitive profile of children assessed by Children Memory Scale (CMS) at Visit 2.

    Memory tests: Children Memory Scale (CMS), the following composites will be considered in our study:

    • Immediate and delayed visual memory : face recognition and dot location
    • Immediate and delayed verbal memory, recognition : stories, word pairs
    • Learning: dot location and word pairs
    • Attention, concentration: numbers, sequences

  2. Rey figure test

    Time frame: 3 months

    Neurocognitive profile of children assessed by visuoperceptual test (Rey Figure test) at Visit 2

  3. Revised - Child Measure of Anxiety Scale (R- CMAS) score

    Time frame: 15 months

    Emotional profile assessed by Revised - Child Measure of Anxiety Scale (R- CMAS) score

  4. Mood Depressive Inventory for Children (MDI- C) score

    Time frame: 15 months

    Emotional profile assessed by Mood Depressive Inventory for Children (MDI- C) score

  5. Child Behavior Checklist (CBCL) score

    Time frame: 15 months

    Emotional profile assessed by Child Behavior Checklist (CBCL) score

  6. Evaluation of the benefits of in utero DEX in preventing or reducing the virilization of external genitalia in CAH girls

    Time frame: Day 1

    The anatomical evaluation (phenotyping) of girls' external genitalia was performed at the time of the surgical correction and included the measurement of the genital tubercule (GT), the distance between the perineum and the urethra-vaginal confluence, the degree of fusion of the genital folds (labia majora), their pigmentation and creases. The measurement of the ano-genital distance was not routine practice in the past.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Multicentric Evaluation of in Utero Dexamethasone (DEX) on the Cognitive Development of Children at Risk of Congenital Adrenal Hyperplasia

Acronym: Prenatal Dex

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2016
Registry last updated
Dec 11, 2025

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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