Craniocerebral TraumaENDOC TC 2NCT07533435
Long-term Follow-up of Pituitary and Hypothalamic Dysfunction in Children Who Have Suffered Moderate to Severe Head Trauma Included in the ENDOC TC Cohort
An observational study of Craniocerebral Trauma and Hypothalamic-pituitary Disorders, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Craniocerebral Trauma, Hypothalamic-pituitary Disorders, Pediatric
- What is being tested?
- Telephone questionnaire
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2026to 30 Sep 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patient deceased since the end of Endoc TC study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service d'Endocrinologie, Diabétologie et Métabolisme Pédiatriques, Hôpital Femme-Mère-Enfant de Lyon
Bron, 69677
Kevin PERGE, M.D., +33 4 72 11 88 90, kevin.perge@chu-lyon.fr
Camille BEDUNEAU, +33 4 72 11 88 90, camille.beduneau@chu-lyon.fr
About this study
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.
Read more
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.
- Being tested
- Telephone questionnaire
- Keywords
- Traumatic brain injury, Anterior pituitary deficits, Growth delaus, Pituitary or hypothalamic hormone deficiency, Initial Endoc TC study (Ref. Clinical Trials : NCT01250132)
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telephone questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Month 0 through Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start22 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniocerebral TraumaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533435
- Sponsor's protocol ID
- 69HCL25_1080
- Other IDs
- 2025-A02661-48
- Acronym
- ENDOC TC 2
- Status last verified
- May 2026
- First submitted
- 8 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No