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Prenatal Dex Study (Prenatal Dex)

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ClinicalTrials.gov Identifier: NCT02795871
Recruitment Status : Unknown
Verified February 2017 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : June 10, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE May 25, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date February 23, 2017
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • 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
  • Rey figure test [ Time Frame: 3 months ]
    Neurocognitive profile of children assessed by visuoperceptual test (Rey Figure test) at Visit 2
  • 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
  • Mood Depressive Inventory for Children (MDI- C) score [ Time Frame: 15 months ]
    Emotional profile assessed by Mood Depressive Inventory for Children (MDI- C) score
  • Child Behavior Checklist (CBCL) score [ Time Frame: 15 months ]
    Emotional profile assessed by Child Behavior Checklist (CBCL) score
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prenatal Dex Study
Official Title  ICMJE Multicentric Evaluation of in Utero Dexamethasone (DEX) on the Cognitive Development of Children at Risk of Congenital Adrenal Hyperplasia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Congenital Adrenal Hyperplasia
Intervention  ICMJE Behavioral: Neuropsychological and cognitive assessment
Study Arms  ICMJE
  • Experimental: Group D+ 1
    Girls and boys at risk of CAH treated in utero by Dexamethasone but unaffected.
    Intervention: Behavioral: Neuropsychological and cognitive assessment
  • Experimental: Group D+ 2
    Girls and boys affected by CAH and treated in utero by Dexamethasone.
    Intervention: Behavioral: Neuropsychological and cognitive assessment
  • Active Comparator: : Group D - 1
    Girls and boys not affected by CAH and not treated in utero by Dexamethasone.
    Intervention: Behavioral: Neuropsychological and cognitive assessment
  • Active Comparator: Group D - 2
    Girls and boys affected by CAH and not treated in utero by Dexamethasone.
    Intervention: Behavioral: Neuropsychological and cognitive assessment
  • Group D - 3
    Girls and boys enrolled in school closed to Lyon
    Intervention: Behavioral: Neuropsychological and cognitive assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02795871
Other Study ID Numbers  ICMJE 69HCL14_0447
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Véronique TARDY-GUIDOLLET, MD PHD Groupement Hospitalier Est - Laboratoire d'endocrinologie moléculaire et maladies rares - Centre de biologie et de pathologie Est.
PRS Account Hospices Civils de Lyon
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP