study of demographics, clinical, laboratory and haemodynamic profile of neonates with fungal sepsis: A retrospective study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To retrospectively investigate the clinical, laboratory, and hemodynamic characteristics of newborns admitted to Bharati NICU with fungal sepsis between 2022 and 2025.
研究概览
简要总结
INTRODUCTION
Whilebacterial sepsis is one of the major causes of neonatal mortality globally andnationally, fungal sepsis has alarmingly come up in the last two decades [1].Increase in preterm deliveries with more number of very low birth weight (VLBW)and extremely low birth weight (ELBW) neonates is the commonest associated riskfactor for increase in fungal sepsis. The overall mortality due to fungalsepsis is around 50% in VLBW and higher in ELBW neonates [2]. Although, the most common speciesisolated is Candida albicans, there has been a surge in non-albicans Candidaspecies outbreaks which was isolated in 30-90% cases in India [3]. The studiedclinical spectrum of fungal sepsis includes incidence of respiratory distress,shock, necrotising enterocolitis, hyperglycaemia, meningitis, solid organabscess, endocarditis, endophthalmitis among others [3-6]. The associatedcardiac findings include an intracardiac mass and endocarditis [7]. However,the functional echocardiographic parameters in fungal sepsis remain unexplored.Through this reterospective observational study, we will be discussingclinical, laboratory, ultrasonography and echocardiographic profile of lastthree years.
AIM AND OBJECTIVES
AIM
Toretrospectively investigate the clinical, laboratory, and hemodynamiccharacteristics of newborns admitted to Bharati NICU with fungal sepsis between2022 and 2025.
PRIMARY OBJECTIVES
A study to evaluate the clinical, demographic, and laboratory profiles ofnewborns admitted to the Bharati NICU from 2022 to 2025, with an emphasis onhaemodynamic parameters, antibiotic sensitivity, and clinical outcomes.
MATERIAL AND METHODS
Study design: Retrospective observational study
Duration of study: The enrolment period will bebetween year 2022 to 2025
Sample size: all neonates from 0 to 28 days of lifeadmitted in Bharati hospital NICU between year 2022 to 2025, with fungalculture (blood, CSF, urine) positive will be included in sample size
Setting: TertiarycareNeonatal Intensive Care Unit(NICU), Department of Neonatology, Bharati Vidyapeeth (Deemed to Be University)Medical College Hospital Research Centre, Pune.
Inclusion criteria: all neonates from 0 to 28 daysof life admitted to Bharati Hospital NICU between year 2022 to 2025 with fungalculture positive will be included in the study.
Method:
After ethicalcommittee approval. This retrospective study will be conducted between year2022 to 2025 in a tertiary care NICU of Bharati Vidyapeeth medical college andresearch centre, Pune. Data of all new borns less than 28 days of life admittedin NICU in defined time period in whom fungal organism was isolated in any ofthe culture (blood, CSF, urine) collected from records. Data about following parameters demographics,risk factors, clinical parameters, laboratory parameters, culture reports(blood, CSF, urine) along with sensitivity pattern 2D ECHO, renal, abdominaland cranial ultrasonography, fundus examination will also be retrieved. All thedata will be analysed statistically. Personal information of the patient willbe kept anonymous.
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
- •All neonates from 0 to 28 days of life admitted to Bharati Hospital NICU between year 2022 to 2025 with fungal culture positive will be included in the study.
排除标准
- 未提供
结局指标
主要结局
To retrospectively investigate the clinical, laboratory, and hemodynamic characteristics of newborns admitted to Bharati NICU with fungal sepsis between 2022 and 2025.
时间窗: 2022 to 2025 (3 years )
次要结局
- A study to evaluate the clinical, demographic, and laboratory profiles of newborns admitted to the Bharati NICU from 2022 to 2025, with an emphasis on haemodynamic parameters, antibiotic sensitivity, and clinical outcomes.(2022 to 2025 (3 years ))
