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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01250132
First received: November 25, 2010
Last updated: January 17, 2013
Last verified: November 2010
  Purpose

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.


Condition Intervention
Moderate to Severe Traumatic Brain Injury
Other: Biological and behavioral explorations

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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?

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Biological and behavioral explorations

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)


  Eligibility

Ages Eligible for Study:   2 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250132

Contacts
Contact: Etienne JAVOUHEY, MD, PhD 427 856 156 ext +33 etienne.javouhey@chu-lyon.fr

Locations
France
CHU de Grenoble Not yet recruiting
Grenoble, France, 38 000
Contact: Clémentine DUPUIS, MD         
Principal Investigator: Clementine DUPUIS, MD         
Hospices Civils de Lyon Recruiting
Lyon, France, 69000
Contact: Etienne JAVOUHEY, MD, PhD    427 856 156 ext +33    etienne.javouhey@chu-lyon.fr   
Principal Investigator: Etienne JAVOUHEY, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Etienne JAVOUHEY, MD, PhD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01250132     History of Changes
Other Study ID Numbers: 2010.599
Study First Received: November 25, 2010
Last Updated: January 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Traumatic brain injury
Paediatrics
Hypopituitarism

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2014