- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02795871
Prenatal Dex Study (Prenatal Dex)
Multicentric Evaluation of in Utero Dexamethasone (DEX) on the Cognitive Development of Children at Risk of Congenital Adrenal Hyperplasia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bron, France, 69677
- Recruiting
- Groupement Hospitalier Est - Laboratoire d'endocrinologie moléculaire et maladies rares - Centre de biologie et de pathologie Est. 59 boulevard Pinel
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Contact:
- Véronique TARDY-GUIDOLLET, MD PHD
- Phone Number: +33 (0)4.72.12.96.35
- Email: veronique.tardy@chu-lyon.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group D+ 1
Girls and boys at risk of CAH treated in utero by Dexamethasone but unaffected.
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Experimental: Group D+ 2
Girls and boys affected by CAH and treated in utero by Dexamethasone.
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Active Comparator: : Group D - 1
Girls and boys not affected by CAH and not treated in utero by Dexamethasone.
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Active Comparator: Group D - 2
Girls and boys affected by CAH and not treated in utero by Dexamethasone.
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Other: Group D - 3
Girls and boys enrolled in school closed to Lyon
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intelligence quotient
Time Frame: 3 months
|
Wechsler Intelligence Scale for Children (WISC) is designed to measure human intelligence. WISC-IV includes:
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
3 months
|
Rey figure test
Time Frame: 3 months
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Neurocognitive profile of children assessed by visuoperceptual test (Rey Figure test) at Visit 2
|
3 months
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Revised - Child Measure of Anxiety Scale (R- CMAS) score
Time Frame: 15 months
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Emotional profile assessed by Revised - Child Measure of Anxiety Scale (R- CMAS) score
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15 months
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Mood Depressive Inventory for Children (MDI- C) score
Time Frame: 15 months
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Emotional profile assessed by Mood Depressive Inventory for Children (MDI- C) score
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15 months
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Child Behavior Checklist (CBCL) score
Time Frame: 15 months
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Emotional profile assessed by Child Behavior Checklist (CBCL) score
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15 months
|
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.
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Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Véronique TARDY-GUIDOLLET, MD PHD, Groupement Hospitalier Est - Laboratoire d'endocrinologie moléculaire et maladies rares - Centre de biologie et de pathologie Est.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Endocrine System Diseases
- Gonadal Disorders
- Disorders of Sex Development
- Urogenital Abnormalities
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Adrenal Gland Diseases
- Steroid Metabolism, Inborn Errors
- Hyperplasia
- Adrenal Hyperplasia, Congenital
- Adrenogenital Syndrome
- Adrenocortical Hyperfunction
Other Study ID Numbers
- 69HCL14_0447
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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