Status:
COMPLETED
Ante-hypophyseal Dysfunctions in Children Following Moderate to Severe Traumatic Brain Injuries
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Moderate to Severe Traumatic Brain Injury
Eligibility:
All Genders
2-16 years
Phase:
NA
Brief Summary
Annual incidence of severe traumatic brain injuries (TBI) varies from 180 to 300 out of 100.000. Mortality or severe sequelae risk is increased 8 fold after a TBI. Studies in adults showed an ante-hyp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2018
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01250132
Start Date
October 1 2010
End Date
April 13 2018
Last Update
September 4 2019
Active Locations (2)
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1
CHU de Grenoble
Grenoble, France, 38 000
2
Hospices Civils de Lyon
Lyon, France, 69000