An observational study in Craniocerebral Trauma, Hypothalamic-pituitary Disorders and Pediatric, sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Hospices Civils de Lyon · Observational
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.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's planned enrollment of 90 is below the median of 180 across 111 observational studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients included in the Princeps Endoc TC study in Lyon
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Telephone questionnaire
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.
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.
Time frame: From Month 0 through Month 6
Start is estimated for Apr 2026; primary completion for Sep 2026, 5 months later.
Of 43 non-industry observational studies under Craniocerebral Trauma, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 49. This study's planned 5 months is below that.
Counting every sponsor, half of 43 studies reached it within 32 months; a quarter within 15 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.