Pituitary Function Assessment after Traumatic Brain Injury in Children: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Incidence of pituitary disorders in children with traumatic brain injury
研究概览
简要总结
Traumatic brain injury is one of the common injuries seen in childhood. Apart from the immediate risk of mortality and long term neurological deficits, traumatic brain injury is also associated with early or late hypothalamic-pituitary dysfunction. The present literature shows that almost 25-45% of adults develop hypopituitarism after traumatic brain injury. Similar information is scarce in the pediatric population. Few studies with small sample size have shown transient hypopituitarism in 15-30% by 6 months which recovers in most by 12 months. However, newer pituitary deficiencies were reported in a few patients at 12 months after traumatic brain injury.
The present study is proposed as a prospective cohort study to estimate the incidence of hypopituitarism in children with traumatic brain injury. All children aged 3 months to below 18 years who will be hospitalized for a clinical indication after a traumatic brain injury will be enrolled. Children with a pre-existing endocrine disorder, central nervous system disorder, major congenital malformations or with the intake of drugs in last 12 months which can interfere with hormonal estimation will be excluded.
Assuming the proportion of children with hypopituitarism at 12 months as 7.33% from an earlier study, confidence limits (d)= 0.1 and alpha error as 5%, a total of 104 subjects will be needed. Accounting for 10% lost to follow-up, the total sample of 115 children will be enrolled.
The baseline clinical details of enrolled subjects will be recorded. Markers of neuronal inflammation will be recorded in the blood. Endocrinal evaluation at baseline for water and electrolyte disturbances, and function of thyroid axis, cortisol axis, prolactin, growth axis, and sex-hormones will be done. Those who are detected with any abnormality will be treated as per standard protocol. The children who are discharged will be followed-up at three monthly intervals for clinical monitoring. They will be subjected to laboratory estimation of pituitary hormonal profile over a period of two years at 6, 12 and 24 months. The incidence and time-to event for hypopituitarism will be recorded. The proportion of hypopituitarism with severity of brain injury and type of brain injury will also be evaluated. The natural course of hypopituitarism during the study period will be noted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Month(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 3 month to 16 years
- •Hospitalized for a clinical indication like altered sensorium, seizures, amnesia, repeated vomiting, bleeding nose or Ear, skull fracture, or neurological signs after traumatic brain injury.
排除标准
- •Patients who succumb within first 48 hours of hospitalization
- •Patients with pre-existing endocrinal disorder unrelated to existing illness
- •Patients with previously diagnosed static or progressive central nervous system disease (like epilepsy, brain tumor, meningoencephalitis, cerebral palsy)
- •Patients with history of consumption of drugs in the last 12 months which can affect interpretation of pituitary hormone levels (example corticosteroids, anti-epileptic drugs)
- •Patients with any major congenital anomalies (example neural tube defects) or chromosomal disorders
- •Patients who discontinue treatment before discharge.
结局指标
主要结局
Incidence of pituitary disorders in children with traumatic brain injury
时间窗: Baseline, 6 months, 12 months, 24 months
次要结局
- a.Association of pituitary dysfunction with the injury characteristics (severity, type, mechanism)(b.Association of pituitary dysfunction with neuronal injury biomarkers)