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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient deceased since the end of Endoc TC study

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Telephone questionnaire

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Cohort of Children with Moderate-to-Severe Traumatic Brain Injury Admitted to Intensive Care1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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