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临床试验/NCT06211192
NCT06211192已完成不适用

Evaluation of the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures: A Single-center Retrospective Study

Balikesir University1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
158
试验地点
1
主要终点
compile risk elements linked to extended use of anti-seizure medication retrospectively

研究概览

简要总结

The investigators aimed to determine the factors for ceasing anti-seizure medication in infants who experienced seizures during the neonatal period. This retrospective, single-center, descriptive study was conducted in Balıkesir between December 2020 and February 2023, and 157 neonates were recruited.

详细描述

This retrospective, single-center, descriptive study was conducted at the Department of Paediatric Neurology between December 2020 and February 2023, and 157 neonates were recruited to determine the factors related to ceasing ASM treatment in infants at a follow-up 2 years. According to the International League Against Epilepsy (ILAE) classification of neonatal seizures and their etiology, patients who were diagnosed with such seizures and received anti-seizure medication within the first 28 days of life were followed until their ASM was ceased after they were discharged from the neonatal intensive care unit. Infants are defined as children aged younger than 12 months. During this stage of neuronal development, the central nervous system is more susceptible to the harmful effects of external factors. Consequently, the investigators have planned to evaluate the study's initial 12-month follow-up results for our group. Afterwards, the infants were divided into two groups: the first group consisted of infants who continued to receive ASM treatment after 12 months of age (referred to as "infants still on ASM after 12 months", n=69); the second group consisted of infants who had stopped ASM treatment before 12 months of age (referred to as "infants who had ceased ASM before 12 months", n=88).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Hour 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates with seizures diagnosed clinically or with conventional electroencephalography (cEEG) confirmation were enrolled.

排除标准

  • with abnormal paroxysmal events that weren't determined to be seizures by cEEG, amplitude integrated EEG (aEEG) and video records,
  • stopped medications due to their parents' decisions,
  • with missing hospital records,
  • delivered from pregnancies by assisted reproductive techniques were not enrolled.

结局指标

主要结局

compile risk elements linked to extended use of anti-seizure medication retrospectively

时间窗: 1-2 years

Collecting the risk elements associated with long-term usage of anti-seizure medication from the participants' medical records in a retrospective manner.

次要结局

未报告次要终点

研究者

发起方
Balikesir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

İpek Dokurel

Medical Doctor

Balikesir University

研究点 (1)

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