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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

NCT07533435 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-22
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07533435 on ClinicalTrials.gov