Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT01250132
Eligibility Criteria:
Inclusion Criteria:
* children from 2 months to 16 years
* in the intensive care unit
* TBI : moderate (Glasgow Coma Scale (GCS) between 9 and 12) to severe (GCS \<9), whatever the mechanism involved
* informed consent form signed by parents
Exclusion Criteria:
* obesity (Body Mass Index (BMI) \> 97th percentile for the age)
* patient already under replacement therapy.
* patient taking AntiEpileptic Drugs (AEDs)
* patient with long-term systemic corticotherapy
* history of neurological disease or learning difficulties
* no covered by a national health insurance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
16 Years
Study:
NCT01250132
Study Brief:
Protocol Section:
NCT01250132