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CTRI Number  CTRI/2024/03/064305 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 18/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding the neonatal infection and postmortem findings 
Scientific Title of Study   Perceptions and Autopsy Pathology of Sepsis-Related Neonatal Deaths in Neonatal Intensive Care Unit 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JULY MARY JOHNSON 
Designation  PhD SCHOLAR 
Affiliation  Kasturba Medical College,Manipal Manipal Academy of Higher Education 
Address  Centre for Foetal and Perinatal Pathology Department of Pathology Kasturba Medical College,Manipal Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  7306567061  
Fax    
Email  mary.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Mary Mathew 
Designation  Professor and Head 
Affiliation  Kasturba Medical College,Manipal Manipal Academy of Higher Education 
Address  Centre for Foetal and Perinatal Pathology Department of Pathology Kasturba Medical College, Manipal Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9845678806  
Fax  918202570062  
Email  mary.mathew@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Mary Mathew 
Designation  Professor and Head 
Affiliation  Kasturba Medical College,Manipal Manipal Academy of Higher Education 
Address  Centre for Foetal and Perinatal Pathology Department of Pathology Kasturba Medical College, Manipal Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9845678806  
Fax  918202570062  
Email  mary.mathew@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital, Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
July Mary Johnson  Kasturba Medical College, Manipal  Centre for Foetal and Perinatal Pathology Department of Pathology Kasturba Medical College, Manipal
Udupi
KARNATAKA 		 7306567061

mary.kmcmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthcare providers directly involved in neonatal care of Kasturba Medical College, Manipal (Doctors,nurses,senior residents, pathologists, general duty workers)  
Patients  (1) ICD-10 Condition: P369||Bacterial sepsis of newborn, unspecified, (2) ICD-10 Condition: P379||Congenital infectious or parasiticdisease, unspecified, (3) ICD-10 Condition: P359||Congenital viral disease, unspecified, (4) ICD-10 Condition: P399||Infection specific to the perinatal period, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional autopsy  Conventional autopsy will be performed which is a gold standard 
Intervention  Standardization of Minimally Invasive Tissue Sampling (MITS) technique for intestine sampling  Intestinal biopsies will be collected using MITS technique in 20 babies. If the invention is sensitive, more samples will be included 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  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 100.
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 
 
ExclusionCriteria 
Details  Objectives 2 and 3: Autolysed or macerated neonates
Objective 1: Those who are not consented 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Objective 3: Able to standardize the MITS protocol for intestinal sampling using 20 cases  May 2024 to May 2025 
 
Secondary Outcome  
Outcome  TimePoints 
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

Objective 2: Autopsy examinations can reveal the extent & type of organ damage in sepsis. This includes damage to vital organs such as the lungs, heart, liver, kidneys, & brain. Provide insights about the association of clinical & autopsy findings in sepsis case. Identification of etiological agents in sepsis-related neonatal death
 		 May 2024 to May 2027 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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

 

 

 

 

 

 

 

 


 
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