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

NCT01250132 | Completed

• 1 other identifier: 2010.599
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Moderate to Severe Traumatic Brain Injury

Keywords

Traumatic brain injury; Paediatrics; Hypopituitarism

Outcome Measures

Primary Outcomes (1)

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

  12 months after inclusion

Secondary Outcomes (4)

• 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

• 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

• 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

Study Arms (1)

Moderate to severe Traumatic Brain Injury

OTHER

Assessment of hypopituitarism. Blood tests at different moments: * day 0 * when leaving intensive care unit * month 3 * month 12

Other: Biological and behavioral explorations

Interventions

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)

Moderate to severe Traumatic Brain Injury

Eligibility Criteria

• Age: 2 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

CHU de Grenoble

Grenoble, 38 000, France

Location

Hospices Civils de Lyon

Lyon, 69000, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hypopituitarism

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pituitary Diseases; Hypothalamic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Etienne JAVOUHEY, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2010
• First Posted: November 30, 2010
• Study Start: October 1, 2010
• Primary Completion: April 13, 2018
• Study Completion: April 13, 2018
• Last Updated: September 4, 2019

Record last verified: 2019-08

Locations

FR (2)