Ante-hypophyseal Dysfunctions in Children Following Moderate to Severe Traumatic Brain Injuries

Study Overview
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Brief Summary
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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-hypophyseal deficit in 28 to 68 % of patients with a TBI. The most common deficit is Growth Hormone Deficit (GHD); followed by gonadotropic and corticotropic (AdrenoCorticoTropic Hormone (ACTH)) insufficiencies. Thyrotropic deficits (Thyroid-Stimulating Hormone (TSH)) are less frequent. From a pathophysiological point of view, the lesional mechanism responsible for hypopituitarisms would be a damage of hypophyseal vessels or hypothalamic-pituitary vessels. The frequency of pituitary deficits and the potential beneficial effects of replacement therapy on quality of life, tiredness, loss of energy and productivity, justify the systematic detection of the deficits in patients with moderate to severe TBI. Study hypotheses : At the present time, the lack of data in children does not give us the opportunity to affirm that one part of the symptoms showed by children with post-TBI neuropsychological sequelae, are linked to pituitary deficiency and that they can be improved with a replacement therapy. Firstly, it is essential to better understand the natural history of post-TBI pituitary deficiencies, studying the connexion between observed deficiencies in acute and late phase of sequelae.

Official Title
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Are Ante-hypophyseal Dysfunctions in the Acute Phase of Moderate to Severe Traumatic Brain Injury Predictive of Long-term Ante-hypophyseal Sequelae in Children?

Conditions
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Moderate to Severe Traumatic Brain Injury

Intervention / Treatment
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* Other: Biological and behavioral explorations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Moderate to severe Traumatic Brain Injury<br>Assessment of hypopituitarism. Blood tests at different moments: day 0 when leaving intensive care unit month 3 month 12 | Other: Biological and behavioral explorations<br>* Blood dosages: biochemistry pituitary gland somatotropic axis corticotropic axis gonadotropic axis thyrotropic axis antidiuretic axis Questionnaires and scales (quality of life, Vineland Adaptive Behavior Scales (VABS)-II)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the link between pituitary deficiencies highlighted at the acute phase and one year after moderate to severe TBI. |  | 12 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the association between pituitary deficiencies highlighted at the acute phase, 3 months and 1 year after moderate to severe TBI, globally and per deficiency category. |  | day0, when leaving intensive care unit, month3 and month12 | 
| Identify the other risk factors of deficiency, during the acute phase and the tardive phase i.e. signs of gravity of the TBI, type of cerebral lesion, age, lesional mechanism. |  | day0, when leaving intensive care unit, month3 and month12 | 
| Study the correlation between corticotropic deficiencies and post-hypophysis insufficiencies during the acute phase and the hemodynamic instability over the first 3 days after the TBI |  | day0 to day3 | 
| Compare the level and the type of behavioural and neuropsychological sequelae in children suffering from a TBI, with and without hypopituitarism. |  | day0, when leaving intensive care unit, month3 and month12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, Paediatrics, Hypopituitarism