Service d'Endocrinologie, Diabétologie et Métabolisme Pédiatriques, Hôpital Femme-Mère-Enfant de Lyon
Bron, 69677, France
Location contact
Camille BEDUNEAU
CONTACT
Kevin PERGE, M.D.
CONTACT
Kevin PERGE, M.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07533435
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.
Trial opening soon.
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Observational
Bron, 69677, France
Camille BEDUNEAU
CONTACT
Kevin PERGE, M.D.
CONTACT
Kevin PERGE, M.D.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Contact information is provided by the study sponsor or research team.
Camille BEDUNEAU
CONTACT
Kevin PERGE, M.D.
CONTACT
Hospices Civils de Lyon
Other
Acronym: ENDOC TC 2
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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