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NCT Number: NCT07533435

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Camille BEDUNEAU

CONTACT

[email protected]

+33 4 72 11 88 90

Kevin PERGE, M.D.

CONTACT

[email protected]

+33 4 72 11 88 90

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ENDOC TC 2

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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