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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02795871 |
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Date of registration:
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25/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prenatal Dex Study
Prenatal Dex |
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Scientific title:
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Multicentric Evaluation of in Utero Dexamethasone (DEX) on the Cognitive Development of Children at Risk of Congenital Adrenal Hyperplasia |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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500 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02795871 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Véronique TARDY-GUIDOLLET, MD PHD |
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Address:
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Telephone:
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(0)4.72.12.96.35 |
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Email:
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veronique.tardy@chu-lyon.fr |
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Affiliation:
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Name:
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Véronique TARDY-GUIDOLLET, MD PHD |
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Address:
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Telephone:
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(0)4.72.12.96.35 |
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Email:
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veronique.tardy@chu-lyon.fr |
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Affiliation:
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Name:
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Véronique TARDY-GUIDOLLET, MD PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Groupement Hospitalier Est - Laboratoire d'endocrinologie moléculaire et maladies rares - Centre de biologie et de pathologie Est. |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Years
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Congenital Adrenal Hyperplasia
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Intervention(s)
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Behavioral: Neuropsychological and cognitive assessment
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Primary Outcome(s)
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Intelligence quotient
[Time Frame: 3 months]
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Secondary Outcome(s)
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Children Memory Scale (CMS)
[Time Frame: 3 months]
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Revised - Child Measure of Anxiety Scale (R- CMAS) score
[Time Frame: 15 months]
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Child Behavior Checklist (CBCL) score
[Time Frame: 15 months]
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Evaluation of the benefits of in utero DEX in preventing or reducing the virilization of external genitalia in CAH girls
[Time Frame: Day 1]
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Rey figure test
[Time Frame: 3 months]
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Mood Depressive Inventory for Children (MDI- C) score
[Time Frame: 15 months]
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Secondary ID(s)
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69HCL14_0447
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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