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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Final height difference in standard deviation (SD), relative to the genetic target height range
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient deceased since the end of Endoc TC study
研究组 & 干预措施
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.
干预措施: Telephone questionnaire (Other)
结局指标
主要结局
Final height difference in standard deviation (SD), relative to the genetic target height range
时间窗: 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.
次要结局
未报告次要终点