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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Moderate to severe Traumatic Brain Injury
Assessment of hypopituitarism. Blood tests at different moments:
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Blood dosages:
Questionnaires and scales (quality of life, Vineland Adaptive Behavior Scales (VABS)-II) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Study the link between pituitary deficiencies highlighted at the acute phase and one year after moderate to severe TBI.
Periodo de tiempo: 12 months after inclusion
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12 months after inclusion
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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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.
Periodo de tiempo: day0, when leaving intensive care unit, month3 and month12
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day0, when leaving intensive care unit, month3 and month12
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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.
Periodo de tiempo: day0, when leaving intensive care unit, month3 and month12
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day0, when leaving intensive care unit, month3 and month12
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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
Periodo de tiempo: day0 to day3
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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.
Periodo de tiempo: day0, when leaving intensive care unit, month3 and month12
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day0, when leaving intensive care unit, month3 and month12
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Etienne JAVOUHEY, MD, PhD, Hospices Civils de Lyon
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2010.599
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