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 | Not Yet Recruiting

• 2 other identifiers: 69HCL25_10802025-A02661-48
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

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.

  From Month 0 through Month 6

Study Arms (1)

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

Telephone questionnaire OTHER

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.

Cohort of Children with Moderate-to-Severe Traumatic Brain Injury Admitted to Intensive Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patient deceased since the end of Endoc TC study

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'Endocrinologie, Diabétologie et Métabolisme Pédiatriques, Hôpital Femme-Mère-Enfant de Lyon

Bron, 69677, France

Location

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Injuries, Traumatic; Pituitary Diseases

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Hypothalamic Diseases; Endocrine System Diseases

Central Study Contacts

Kevin PERGE, M.D.

CONTACT

+33 4 72 11 88 90; kevin.perge@chu-lyon.fr

Camille BEDUNEAU

CONTACT

+33 4 72 11 88 90; camille.beduneau@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): April 22, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)