Ante-hypophyseal Dysfunctions in Children Following Moderate to Severe Traumatic Brain Injuries (Endoc-TC)
Are Ante-hypophyseal Dysfunctions in the Acute Phase of Moderate to Severe Traumatic Brain Injury Predictive of Long-term Ante-hypophyseal Sequelae in Children?
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Grenoble, Francia, 38 000
- CHU de Grenoble
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Lyon, Francia, 69000
- Hospices Civils de Lyon
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: Moderate to severe Traumatic Brain Injury
Assessment of hypopituitarism. Blood tests at different moments:
|
Blood dosages:
Questionnaires and scales (quality of life, Vineland Adaptive Behavior Scales (VABS)-II) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Study the link between pituitary deficiencies highlighted at the acute phase and one year after moderate to severe TBI.
Lasso di tempo: 12 months after inclusion
|
12 months after inclusion
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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.
Lasso di tempo: day0, when leaving intensive care unit, month3 and month12
|
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.
Lasso di tempo: day0, when leaving intensive care unit, month3 and month12
|
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
Lasso di tempo: day0 to day3
|
day0 to day3
|
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Compare the level and the type of behavioural and neuropsychological sequelae in children suffering from a TBI, with and without hypopituitarism.
Lasso di tempo: day0, when leaving intensive care unit, month3 and month12
|
day0, when leaving intensive care unit, month3 and month12
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Etienne JAVOUHEY, MD, PhD, Hospices Civils de Lyon
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2010.599
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