跳至主要内容
临床试验/CTRI/2025/10/095805
CTRI/2025/10/095805招募中不适用

Clinical profile and outcome prediction in children with Status Epilepticus using STEPSS : Status Epilepticus in Paediatric patients Severity Score

Not applicable1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2025年10月22日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
126
试验地点
1
主要终点
Short term outcome of status epilepticus among children as estimated using the Status Epilepticus in Paediatric patients severity score

研究概览

简要总结

This project is a prospective, longitudinal study titled Clinical profile and outcome prediction in children with Status Epilepticus using STEPSS Status Epilepticus in Paediatric patients Severity Score.

The aim is to determine the clinical characteristics and estimate the short term outcome of Status Epilepticus SE using the STEPSS score in children aged 1 month to 18 years admitted to the Paediatric Intensive Care Unit PICU at Kasturba Hospital Manipal.

The primary objective is to estimate the short term outcome of SE using the STEPSS score. The secondary objectives include determining demographic and clinical factors associated with SE and estimating disability at the time of discharge using the Functional Status Scale FSS.

The study is justified by the need to identify local etiological factors and optimize clinical care for children with SE, using a simple, validated tool like STEPSS for early risk stratification and outcome prediction.

Children between 1 month and 18 years with SE admitted to the PICU at Kasturba Hospital, Manipal, will be included, excluding those with psychogenic non epileptic seizures.

The estimated sample size is 126 and study period between August 2025 to March 2027. The study will use the Status Epilepticus in Paediatric patients Severity Score STEPSS for outcome prediction and the Functional Status Scale FSS to assess disability at discharge. After obtaining Institutional Ethics Committee and CTRI approvals, informed consent will be taken from parents. Clinical data, including demographics, history, physical and neurological examinations, and the STEPSS score will be recorded at admission. Disability at discharge will be assessed using the FSS, with a favourable outcome for children with pre-morbid disability defined as a return to their baseline functional status. Statistical methods will include descriptive statistics, tests for data normality Shapiro-Wilk or Kolmogorov-Smirnov, and the application of parametric or non-parametric tests as appropriate. Predictive accuracy of STEPSS will be tested by calculating specificity, sensitivity, Positive Predictive Value , and Negative Predictive Value , as well as F1 scores. The optimal cut off point will be determined using the Receiver Operating Characteristic curve and Youden’s index.

Written informed consent will be obtained from parents, and confidentiality will be maintained by not collecting patient details such as name, address, or contact details. The study will not involve any cost as the required EEG is part of the routine standard of care for children with SE.The study is expected to provide better insight into the clinical profile and outcomes of SE using STEPSS and FSS.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children between 1 month to 18 years with status epilepticus admitted to Paediatric Intensive Care Unit of Department of Paediatrics, Kasturba Hospital Manipal.

排除标准

  • Psychogenic non-epileptic seizures.

结局指标

主要结局

Short term outcome of status epilepticus among children as estimated using the Status Epilepticus in Paediatric patients severity score

时间窗: Status Epilepticus in Paediatric patients severity score will be noted at the time of presentation.

次要结局

  • Disability assessment using the Functional Status scale.(Disability at the time of discharge assessed using the Functional Status scale.)

研究者

申办方类型
Other [Not applicable ]
责任方
Principal Investigator
主要研究者

Dr Aditi Somashekar Naidu

Kasturba Medical College Manipal

研究点 (1)

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