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临床试验/CTRI/2025/12/098850
CTRI/2025/12/098850尚未招募不适用

Clinical features and short term outcomes in neonates with seizures

Kasturba Hospital Manipal1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年12月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
105
试验地点
1

研究概览

简要总结

This is a prospective observational study conducted in a tertiary care neonatal intensive care unit over a period of  2 years. The study will include term neonates who develop seizures within the first 28 days of life. A total sample size of 105 neonates has been calculated. The study aims to describe the clinical profile, causes, and short term outcomes of neonatal seizures and to identify factors that may predict poor neurological outcome at discharge. Detailed clinical history, examination findings, seizure characteristics, laboratory investigations, EEG findings, and neuroimaging results will be recorded. Seizures will be classified as per the ILAE neonatal seizure classification. All infants will receive standard treatment as per NICU protocol and no additional procedures will be performed as part of the study. Statistical analysis will be performed to identify associations between seizure types, underlying causes, EEG abnormalities, and short term outcomes. The study is expected to provide useful information relevant to early diagnosis, management, and counseling of families in settings with limited diagnostic resources. Ethical approval and written informed consent from parents or guardians will be obtained.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Term Neonates with seizures occurring within the first 28 days of life admitted to NICU.

排除标准

  • Neonates with seizure like phenomenon without other evidence of seizure activity (without EEG correlation), these clinical events can be jitteriness, exaggerated startle, etc; Neonates with major congenital anomalies except CNS Malformations.

研究者

发起方
Kasturba Hospital Manipal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Jahnavi Jain

Kasturba Medical College Manipal

研究点 (1)

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