CClinicalTrials.gg
Not yet recruitingNCT07533435ENDOC TC 2Updated May 22, 2026

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 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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Sex
All
01

Study 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.

02

Conditions studied

  • Craniocerebral Trauma
  • Hypothalamic-pituitary Disorders
  • Pediatric
  • Endocrinology

Keywords

  • Traumatic brain injury
  • Anterior pituitary deficits
  • Growth delaus
  • Pituitary or hypothalamic hormone deficiency
  • Initial Endoc TC study (Ref. Clinical Trials : NCT01250132)
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

Exclusion Criteria:

  • Patient deceased since the end of Endoc TC study
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Telephone questionnaire

Interventions

  • OtherTelephone 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.

05

What researchers measure

Primary outcomes

  1. 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

06

Study locations

1 site
  • Service d'Endocrinologie, Diabétologie et Métabolisme Pédiatriques, Hôpital Femme-Mère-Enfant de Lyon
    Bron, 69677, France
07

Registry details

Key details

Study ID
NCT07533435
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Apr 16, 2026
Start date
Apr 22, 2026 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
May 22, 2026

Study contacts

Kevin PERGE, M.D.
Contact
kevin.perge@chu-lyon.fr
+33 4 72 11 88 90
Camille BEDUNEAU
Contact
camille.beduneau@chu-lyon.fr
+33 4 72 11 88 90

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Start the discussion