跳至主要内容
临床试验/CTRI/2024/04/066148
CTRI/2024/04/066148尚未招募不适用

To Study Incidence and clinical outcomes of neonatal meningitis in a Level III NICU – a ambispective observational study

Dr Sonali Amol Avale1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月7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
100
试验地点
1
主要终点
To study the incidence of neonatal meningitis

研究概览

简要总结

Neonatal meningitis continues to be a serious health challenge with high mortality and morbidity worldwide . Neonatal meningitis is a diffuse inflammation of the meninges during the first 28 days of life . Despite advances in the management of neonatal meningitis, mortality and neurologic complications are still unacceptably high, especially in developing countries .The risk factors associated with neonatal meningitis in neonatal sepsis might vary from one study area to another .Previous studies found that neonatal meningitis was high in neonates with prematurity , maternal history of chorioamnionitis, Prolonged Rupture of Membrane (PROM) , perinatal asphyxia a , positive blood culture [5], and group B streptococcus bacteremia .In neonates, signs and symptoms of serious infections are often obscure, and the clinical presentation of neonatal meningitis is indistinguishable from that of neonatal sepsis without meningitis . The most important clinical indicators of neonatal meningitis are convulsions, irritability, bulging fontanel, and temperature ≥ 39°C . Therefore, the only confirmatory diagnosis for neonatal meningitis is cerebrospinal fluid analysis. Hence, the current study aimed to determine the magnitude and clinical presentations  of neonatal meningitis among newborns with neonatal sepsis.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • All neonates with positive biochemical parameters((as per the age wise cutoff) in CSF or culture positive meningitis in NICU, Government medical College and Hospital Aurangabad.

排除标准

  • Neonates with negative CSF reports (Biochemical parameters).

结局指标

主要结局

To study the incidence of neonatal meningitis

时间窗: To study the incidence of neonatal meningitis

次要结局

  • To study:(Mortality)

研究者

发起方
Dr Sonali Amol Avale
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sonali Amol Avale

Government Medical college , Sambhaji Nagar

研究点 (1)

Loading locations...

相似试验