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Ante-hypophyseal Dysfunctions in Children Following Moderate to Severe Traumatic Brain Injuries (Endoc-TC)

2019年8月30日 更新者:Hospices Civils de Lyon

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.

研究概览

研究类型

介入性

注册 (实际的)

110

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Grenoble、法国、38 000
        • CHU de GRENOBLE
      • Lyon、法国、69000
        • Hospices Civils de Lyon

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2个月 至 16年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Moderate to severe Traumatic Brain Injury

Assessment of hypopituitarism. Blood tests at different moments:

  • day 0
  • when leaving intensive care unit
  • month 3
  • month 12

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)

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Study the link between pituitary deficiencies highlighted at the acute phase and one year after moderate to severe TBI.
大体时间:12 months after inclusion
12 months after inclusion

次要结果测量

结果测量
大体时间
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.
大体时间: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.
大体时间: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
大体时间:day0 to day3
day0 to day3
Compare the level and the type of behavioural and neuropsychological sequelae in children suffering from a TBI, with and without hypopituitarism.
大体时间:day0, when leaving intensive care unit, month3 and month12
day0, when leaving intensive care unit, month3 and month12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Etienne JAVOUHEY, MD, PhD、Hospices Civils de Lyon

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年10月1日

初级完成 (实际的)

2018年4月13日

研究完成 (实际的)

2018年4月13日

研究注册日期

首次提交

2010年11月25日

首先提交符合 QC 标准的

2010年11月29日

首次发布 (估计)

2010年11月30日

研究记录更新

最后更新发布 (实际的)

2019年9月4日

上次提交的符合 QC 标准的更新

2019年8月30日

最后验证

2019年8月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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