Multicentric evaluation of in utero dexamethasone (DEX) on the cognitive development of children at risk of Congenital Adrenal Hyperplasia - PRENATAL DEX Study

• Register: EUCTR
• Last refreshed on: 18 January 2016
• Main ID: EUCTR2015-003996-32-FR
• Date of registration: 04/12/2015
• Prospective Registration: No
• Primary sponsor: Hospices Civils de Lyon
• Public title: Multicentric evaluation of in utero dexamethasone (DEX) on the cognitive development of children at risk of Congenital Adrenal Hyperplasia - PRENATAL DEX Study
• Scientific title: Multicentric evaluation of in utero dexamethasone (DEX) on the cognitive development of children at risk of Congenital Adrenal Hyperplasia - PRENATAL DEX Study - PRENATAL DEX
• Date of first enrolment: 03/11/2015
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003996-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 5

Countries of recruitment

France

Contacts

• Name: IUNG
• Affiliation: Hospices Civils de Lyon

• Name: IUNG
• Affiliation: Hospices Civils de Lyon

Key inclusion & exclusion 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:
- 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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Intervention(s)

Trade Name: Dectancyl
Pharmaceutical Form:

Primary Outcome(s)

Primary end point(s): IQ assessment (four index)

Timepoint(s) of evaluation of this end point: visit 2

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

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 Outcome(s)

Timepoint(s) of evaluation of this end point: v1, v2 and v3

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

Secondary ID(s)

69HCL14-0447

Source(s) of Monetary Support

Hospices Civils de Lyon