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
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Telephone questionnaire.
- Кому может быть актуально
- Состояния в реестре: Craniocerebral Trauma, Hypothalamic-pituitary Disorders, Pediatric, Endocrinology. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Вмешательства
- Другое 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.
Первичные конечные точки
- Final height difference in standard deviation (SD), relative to the genetic target height range [Срок оценки: From Month 0 through Month 6]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Patient deceased since the end of Endoc TC study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Service d'Endocrinologie, Diabétologie et Métabolisme Pédiatriques, Hôpital Femme-Mère-Enf — Bron
Идентификаторы
NCT: NCT07533435 · 69HCL25_1080 · 2025-A02661-48