Patient with Congenital Adrenal Hyperplasia (CAH) or sibling of a CAH patient . Patient no connection with Congenital Adrenal Hyperplasia MedDRA version: 18.1 Level: PT Classification code 10061630 Term: Adrenogenital syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Dectancyl
Pharmaceutical Form:
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 For 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 Are the trial subjects under 18? yes Number of subjects for this age range: 400 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the neurocognitive effects of in utero treatment with DEX (Dexamethasone) on children who did not need treatment: non-CAH girls and boys treated in utero with DEX who consequently received excessive glucocorticoids during fetal life, in comparison with non-CAH and untreated girls and boys (siblings of CAH and control population).;Secondary Objective: - To assess the emotional effects of in utero treatment with DEX on children who did not need treatment:n comparison with non-CAH and untreated patients (siblings of CAH and control population). -To determine the benefits of DEX for CAH compared to its adverse effects, namely to: - Assess the neurocognitive profile of CAH boys and girls treated with DEX in comparison to CAH girls and boys not treated with DEX with hyperandrogenism with adrenal origin: to evaluate the benefits of DEX in terms of brain development achieved by controlling hyperandrogenism; - Determine the impact of the disease by assessing CAH children not treated with DEX in terms of emotional cues such as social anxiety, self-esteem and mood during their development, in comparison with non-CAH girls and boys not treated with DEX (siblings of CAH and control population); - Assess the benefits of in utero DEX treatment on the prevention of the virilization of the external genitalia in CAH girls ;Primary end point(s): IQ assessment (four index) ;Timepoint(s) of evaluation of this end point: visit 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Neuropsychological assessments - Emotional assessment - Evaluation of the benefits of in utero DEX in preventing or reducing the virilization of external genitalia in CAH girls;Timepoint(s) of evaluation of this end point: v1, v2 and v3 | — |
Countries
France
Contacts
Public ContactIUNG
Hospices Civils de Lyon
Outcome results
None listed