Case Control Study to Identify determinants of Neonatal Sepsis among admitted term and preterm newborns at KNH Shimla.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Assess the risk factors of neonatal sepsis among SNCU admissions at KNH Shimla
研究概览
简要总结
Neonatal sepsis is a significant public health concern in the lower and middle-income countriesof sub-Saharan Africa and South-East Asia. Consequently, despite a decreasing trend in global under-5 mortality and neonatal mortality during the last two decades, the rate of reduction of sepsis-specific mortality has been much slower compared to that of other causes like premature birth or intrapartum complications in these regions. More than six million neonates suffer from severe infections and sepsis annually in these regions, contributing to almost one-quarter of global neonatal deaths per year.
India has the highest incidence of clinical sepsis (17,000/ 1,00,000 live births), [3] with case fatality rate of sepsis among neonates ranges between 25% to 65%.
There are epidemiological differences in the incidence, risk factors, pattern, and antimicrobial sensitivities of pathogens and mortality of neonatal sepsis among different regions and countries in the world. Specific strategies suitable for specific countries to prevent and treat neonatal sepsis are needed to accelerate the progress in preventing neonatal morbidity and mortality. Identification of risk factors and early diagnosis and institution of therapy according to local epidemiology and antimicrobial resistance pattern can improve neonatal survival.
Evidence from reviews of risk factors has been utilized globally to guide the development of management guidelines for neonatal sepsis, and it is similarly recommended that such evidence be used for guideline development for management decisions in India.
There is a lack of evidence on risk factors and common causative agents with their sensitivity patterns of neonatal sepsis in Himachal Pradesh.The present study, therefore, aims to determine the risk factors and etiology of neonatal sepsis with identification of antibiotic resistance pattern among the neonates delivered in a tertiary care teaching hospital in north India
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
- •Neonates diagnosed with sepsis according to established clinical and haematological criteria of IMNCI and/or evidence of positive blood or CSF or urine culture results will be included as cases in this study.
- •Neonates who will not be suspected or diagnosed for neonatal sepsis and admitted to the neonatal unit of KNH due to other indication such as LBW, NNJ, asymtomatic prematurity, for feed progression during the study period will be included as controls.
排除标准
- •Neonates born outside KNH will be excluded from the study.
结局指标
主要结局
Assess the risk factors of neonatal sepsis among SNCU admissions at KNH Shimla
时间窗: 1 year
次要结局
- Profile of organism in newborn sepsis among SNCU admissions at KNH Shimla(1 year)
- Antimicrobial resistance in newborn sepsis SNCU admissions at KNH Shimla(1 year)
研究者
Dr Mohd Asif Qureshi
IGMC, Shimla