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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02661-48 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort of Children with Moderate-to-Severe Traumatic Brain Injury Admitted to Intensive Care | Patients who suffered moderate to severe head trauma during childhood requiring hospitalization in the intensive care unit at the Femme Mère Enfant hospital in Lyon, included in the Endoc TC study Telephone interview to obtain current measurements and endocrine symptoms. Extraction of data from initial Endoc TC study via Easily, secure patient software used by investigators' team. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone questionnaire | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Final height difference in standard deviation (SD), relative to the genetic target height range | 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. | From Month 0 through Month 6 |
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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
Exclusion Criteria:
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Patients who suffered moderate to severe head trauma during childhood requiring hospitalization in the intensive care unit at the Femme Mère Enfant hospital in Lyon, included in the princeps Endoc TC study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin PERGE, M.D. | Contact | +33 4 72 11 88 90 | kevin.perge@chu-lyon.fr | |
| Camille BEDUNEAU | Contact | +33 4 72 11 88 90 | camille.beduneau@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Endocrinologie, Diabétologie et Métabolisme Pédiatriques, Hôpital Femme-Mère-Enfant de Lyon | Bron | 69677 | France |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D000070642 | Brain Injuries, Traumatic |
| D010900 | Pituitary Diseases |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D004700 | Endocrine System Diseases |
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