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 (ENDOC TC 2)

May 20, 2026 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69677
        • Service d'Endocrinologie, Diabétologie et Métabolisme Pédiatriques, Hôpital Femme-Mère-Enfant de Lyon
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kevin PERGE, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final height difference in standard deviation (SD), relative to the genetic target height range
Time Frame: 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.
From Month 0 through Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 22, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL25_1080
  • 2025-A02661-48 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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