跳至主要内容
临床试验/CTRI/2024/03/064305
CTRI/2024/03/064305尚未招募不适用

Perceptions and Autopsy Pathology of Sepsis-Related Neonatal Deaths in Neonatal Intensive Care Unit

NA1 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1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
NA
入组人数
100
试验地点
1
主要终点
Objective 3: Able to standardize the MITS protocol for intestinal sampling using 20 cases

研究概览

简要总结

Introduction

According to WHO’s 2023 progress report, the annual neonatal deaths in India is 468 per 1000 live births, of which 5.7% of deaths are due to sepsis. At the national level, the neonatal mortality rate is 20 per 1000 live births, of which sepsis accounts for 5.3%. Conventional diagnostic autopsy (CDA) is considered a gold standard in establishing the cause of death (COD) in neonates. Although the conventional diagnostic autopsy (CDA) provides critical information on the cause of death (COD), because of sociocultural and religious norms and technical and infrastructural challenges, it is rarely performed.

Minimally Invasive Tissue Sampling (MITS) is an innovative autopsy examination approach for understanding the causes of death. Studies show that approximately 83.3% of diagnoses in MITS for the cause of death were concordant with CDA diagnosis. There is a standardized MITS protocol for all organs except the intestine.

Neonatal sepsis is an infection of the bloodstream in neonates under the age of 28 days due to an immature immune system. Sepsis is a significant threat among the myriad of challenges neonates face, often leading to devastating consequences due to challenges in obtaining a correct diagnosis. Studies show that CDA is the most efficient way to establish the cause of death in neonatal sepsis, and 22% to 81% of additional findings were diagnosed during CDA . Majority of the studies discuss the discrepancies between clinical diagnosis and autopsy findings. However, very few studies discuss the autopsy findings in neonatal sepsis-related deaths

Research Gap

  1. There are only limited studies globally and in India regarding the knowledge, attitude, and perception of healthcare providers towards neonatal autopsy
  2. Limited research has been conducted to investigate the correlation between clinical manifestations and histopathological observations in neonatal sepsis-associated fatalities within the Neonatal Intensive Care Unit (NICU)
  3. There is no standardized MITS protocol for intestinal sampling

Methodology

This is a 3 years retrospective and prospective study conducted in the Department of Pathology and Neonatology of Kasturba Medical College Manipal Karnataka

The study has 3 objectives

Objective I: Knowledge, Attitude, and Perceptions of Health Care Providers Regarding Neonatal Autopsy in a Tertiary Care Hospital in South India: A Qualitative Study

**•**To assess the knowledge, attitude, and perception of health care providers regarding neonatal autopsy practices

•To identify potential challenges and barriers hindering the recommendation of the autopsy by health care providers

Objective II: Autopsy Pathology of Neonatal Sepsis in Neonatal Intensive Care Unit: A Clinico-Histopathological Correlation

•To analyze the autopsy histopathological findings in deaths due to neonatal sepsis

•To assess the concordance between clinical diagnoses and autopsy findings

•To identify the etiological agents and factors contributing to sepsis-related deaths

Objective III: Standardization of Minimally Invasive Tissue Sampling (MITS) technique for intestine sampling

·         To standardize the Minimally Invasive Tissue Sampling (MITS) technique for intestinal biopsies

Expected outcomes

Objective I: Knowledge, Attitude, and Perceptions of Health Care Providers Regarding Neonatal Autopsy in a Tertiary Care Hospital in South India: A Qualitative Study

•       This study will provide insights into the knowledge, attitude, and perception of health care providers towards neonatal autopsy

•       It will contribute to understanding the factors that influence their recommendations to parents regarding neonatal autopsy

•       Findings may inform strategies to improve the acceptance and utilization of neonatal autopsy and MITS as a valuable tool in neonatal care

Objective II: Autopsy Pathology of Neonatal Sepsis in Neonatal Intensive Care Unit: A Clinico-Histopathological Correlation

•       Autopsy examinations can reveal the extent and type of organ damage in sepsis. This includes damage to vital organs such as the lungs, heart, liver, kidneys, and brain

•       Provide insights about the association of clinical and autopsy findings in sepsis cases

•       Identification of etiological agents in sepsis-related neonatal death

Objective III: Standardization of Minimally Invasive Tissue Sampling (MITS) technique for intestine sampling

•       Standardize the intestinal MITS protocol for obtaining intestine biopsies

Importance of research

•       By understanding the knowledge and attitude of the healthcare providers towards neonatal autopsy, we can identify their dilemma and provide training programs to overcome it.

•       By investigating the pathology and circumstances surrounding sepsis-related deaths, researchers can work to identify preventive measures and best practices to reduce the occurrence of these deaths

•       This helps identify areas where the quality of care in NICUs can be improved

•       For parents who have lost a child due to sepsis in a NICU, understanding the circumstances and pathology behind their child’s death is a closure and  it help to make decisions in future pregnancies or medical situations

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

  • Objective 1: Qualitative study in which Face-to-face in-depth Interviews will be conducted until saturation is attained; the participation is fully voluntary.
  • The participants are Healthcare providers directly involved in neonatal care of KMC, Manipal (e.g., obstetricians, neonatologists, paediatricians, nurses, senior residents, pathologists, general duty workers).
  • Objective 2: Retrospective and prospective cross-sectional cohort study (2012 to 2025) in this conventional autopsy will be performed on Neonates who died of sepsis/ suspected sepsis in NICU, KMC, Manipal whose parents/ guardian has consented to an autopsy.
  • Sample size approximately
  • Objective 3: For standardization of MITS technique for intestinal biopsies, 20 neonates who died in NICU, Kasturba Medical College, Manipal whose parents/ guardian have consented to autopsy.

排除标准

  • Objectives 2 and 3: Autolysed or macerated neonates Objective 1: Those who are not consented.

结局指标

主要结局

Objective 3: Able to standardize the MITS protocol for intestinal sampling using 20 cases

时间窗: May 2024 to May 2025

次要结局

  • Objective 1: Thematic analysis of this study will provide insights into the knowledge, attitude, & perception of health care providers towards neonatal autopsy. It will contribute to understanding the factors that influence their recommendations to parents regarding neonatal autopsy

研究者

发起方
NA
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

JULY MARY JOHNSON

Kasturba Medical College,Manipal Manipal Academy of Higher Education

研究点 (1)

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