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NCT Number: NCT01250132

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

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.

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Key information

Conditions

Moderate to Severe Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Nervous System Diseases Pituitary Diseases Trauma, Nervous System Wounds and Injuries

Age range

2 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Grenoble, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological and behavioral explorations

Other

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)

Primary outcomes

  1. Study the link between pituitary deficiencies highlighted at the acute phase and one year after moderate to severe TBI.

    Time frame: 12 months after inclusion

Secondary outcomes

  1. 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.

    Time frame: day0, when leaving intensive care unit, month3 and month12

  2. 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.

    Time frame: day0, when leaving intensive care unit, month3 and month12

  3. 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

    Time frame: day0 to day3

  4. Compare the level and the type of behavioural and neuropsychological sequelae in children suffering from a TBI, with and without hypopituitarism.

    Time frame: day0, when leaving intensive care unit, month3 and month12

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: Endoc-TC

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2010
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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