Are Ante-hypophyseal Dysfunctions in the Acute Phase of Moderate to Severe Traumatic Brain Injury Predictive of Long-term Ante-hypophyseal Sequelae in Children?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Study the link between pituitary deficiencies highlighted at the acute phase and one year after moderate to severe TBI.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Study the link between pituitary deficiencies highlighted at the acute phase and one year after moderate to severe TBI.
时间窗: 12 months after inclusion
次要结局
- 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)
- 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)
- 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)