Craniocerebral Trauma, Endocrinology, Hypothalamic-pituitary Disorders, Pediatric
Conditions
Keywords
Traumatic brain injury, Anterior pituitary deficits, Growth delaus, Pituitary or hypothalamic hormone deficiency, Initial Endoc TC study (Ref. Clinical Trials : NCT01250132)
Brief summary
The annual incidence of traumatic brain injury (TBI), all causes combined, varies between 180 and 300 per 100,000. TBI increases the risk of death or serious sequelae by a factor of 8. Studies conducted in adults have shown an anterior pituitary deficit in 28% to 68% of patients with TBI. The variability of these studies does not currently allow for standardization of the management of these children in either the acute or late phases. Several studies, including a Lyon-based study called Endoc TC (Ref. Clinical Trials: NCT01250132), have aimed to investigate the association between anterior pituitary deficits in the acute phase and those identified a few months after the trauma. Since then, few studies have been conducted more than five years after the trauma to study its pituitary consequences. To date, the investigators have sought to study the long-term prevalence of pituitary and hypothalamic dysfunction in patients who suffered moderate to severe head trauma during childhood, specifically patients included in the initial Endoc TC study in Lyon. To this end, the main objective is to determine the current height of these patients and whether there are any associated growth delays or other clinical signs that may suggest the presence of a pituitary or hypothalamic hormone deficiency. This study consists of a telephone questionnaire lasting approximately 15 minutes, with participants from Lyon who took part in ENDOC TC study, designed to determine the growth of these patients and the presence or absence of symptoms that may be related to post-traumatic damage to the hypothalamic-pituitary system linked to head trauma.
Interventions
After receiving parental non-opposition for minor patients and non-opposition for adults patients, a structured telephone questionnaire is conducted. The interview is not recorded. It lasts approximately 15 minutes.
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Consent of the child if under 18 years of age and no objection from both parents, or no objection from the adult patient * Patients included in the Princeps Endoc TC study in Lyon * Patients who have suffered a traumatic brain injury * Children aged 2 months to 16 years inclusive * Admitted to pediatric intensive care * Initial Glasgow Coma Scale score between 3 and 12, regardless of the mechanism of head injury * Informed consent signed by parents
Exclusion criteria
* Patient deceased since the end of Endoc TC study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final height difference in standard deviation (SD), relative to the genetic target height range | From Month 0 through Month 6 | Final height difference corresponds to the child's current height, collected by telephone interview. The genetic target height range is calculated using the following formula: (Father's Height + Mother's Height) ÷ 2 \[+6.5 for boys/ -6.5 for girls\]. The investigators will use the reference growth curves from the Center for Research in Epidemiology and Statistics (CRESS) to determine heights in SD. |
Countries
France
Contacts
CONTACTKevin PERGE, M.D.
CONTACTCamille BEDUNEAU
Outcome results
None listed