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CTRI Number  CTRI/2020/10/028289 [Registered on: 08/10/2020] Trial Registered Prospectively
Last Modified On: 07/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   Minimally Invasive Tissue Sampling and Postmortem Examination to Know the Cause of Death in Babies with 30 days of Age 
Scientific Title of Study   Minimally Invasive Tissue Sampling and Conventional Autopsy in Establishing Cause of Death in the Neonatal Period 
Trial Acronym  MITS-CAiN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Athira Sreenivas 
Designation  PhD student 
Affiliation  Manipal Academy of Higher Education 
Address  Centre for Foetal and Perinatal Pathology, Department of Pathology, Kasturba Medical College, Manipal,Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9400056955  
Fax  918202570062  
Email  athirasreenivas4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrMary Mathew 
Designation  Professor and Co-ordinator 
Affiliation  Kasturba Medical College, Manipal 
Address  Center for Foetal and Perinatal Pathology, Department of Pathology, Kasturba Medical College, Centre for Basic Sciences, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845678806  
Fax  918202570062  
Email  marymathew883@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrMary Mathew 
Designation  Professor and Co-ordinator 
Affiliation  Kasturba Medical College, Manipal 
Address  Center for Foetal and Perinatal Pathology, Department of Pathology, Kasturba Medical College, Centre for Basic Sciences, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845678806  
Fax  918202570062  
Email  marymathew883@gmail.com  
 
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 = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Athira Sreenivas  Karkala Panchayat  Karkala Panchayat Udupi, Karnataka
Udupi
KARNATAKA 
9400056955

athirasreenivas4@gmail.com 
Athira Sreenivas  Kasturba Hospital ,Manipal  Neonatal Intensive Care Unit, Neonatology, Department of Pediatrics, Kasturba Hospital,Manipal
Udupi
KARNATAKA 
9400056955

athirasreenivas4@gmail.com 
Athira Sreenivas  Kasturba Medical College,Manipal  Autopsy Room,Centre for Foetal and Perinatal Pathology,Department of Pathology, Center for Basic Sciences, Kasturba Medical Colllege, Manipal, Karnataka
Udupi
KARNATAKA 
9400056955

athirasreenivas4@gmail.com 
Athira Sreenivas  Peravoor Panchayat  Peravoor Panchayat Kannur, Kerala
Kannur
KERALA 
9400056955

athirasreenivas4@gmail.com 
 
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  Any married adult from the site (Karkala or Peravoor panchayat) who is interested to take part in the study  
Patients  (1) ICD-10 Condition: P399||Infection specific to the perinatal period, unspecified, (2) ICD-10 Condition: P549||Neonatal hemorrhage, unspecified, (3) ICD-10 Condition: P84||Other problems with newborn, (4) ICD-10 Condition: P968||Other specified conditions originating in the perinatal period, (5) ICD-10 Condition: P220||Respiratory distress syndrome of newborn, (6) ICD-10 Condition: P279||Unspecified chronic respiratory disease originating in the perinatal period,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Autopsy  Conventional autopsy will be performed which is the gold standard Both techniques will be employed on same subject in which the new technique will be compared with gold standard test. Establishment in diagnosing cause of death using both techniques will be studied. 
Intervention  Minimally Invasive Tissue Sampling (MITS)  Using MITS samples will be collected and examined. BARDMonopty needle will be used to collect samples using MITS technique. Samples will be processed and used for diagnosing cause of death 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  Phase I: Approximately 10 in-depth interviews each from the community in Mala Panchayat, Karkala Taluk, Udupi District, Karnataka, and Peravoor Panchayat, Iritty Taluk, Kannur District, Kerala (till saturation is obtained).
10 married adult participants from both genders from 2 states who have children or experienced miscarriages or abortion

Phase II: 150 cases of neonatal deaths subjected to either conventional autopsy or MITS.
150 neonatal deaths occurring in NICU, Pediatrics, KMC, Manipal inclusive of bodies consented for an autopsy which has been retained in the Department of Pathology will be included in the study. In prospective cases, written parental consent will be obtained for MITS or conventional autopsy. In the case of retained bodies, consent has already been obtained for autopsy.
 
 
ExclusionCriteria 
Details  Phase I: Unmarried adults of any gender

Phase II: Macerated babies and fetuses. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Phase I: Perceptions regarding neonatal autopsy, causes of death of a neonate, willingness of the community to know the cause of death and acceptance of MITS.

Phase II: Establishing the cause of death and coding of perinatal and neonatal deaths using the WHO ICD10 and ICD-PM. 
Phase I- 72 weeks
January 2021-June 2022

Phase II- 131 weeks
October 2020-June 2023 
 
Secondary Outcome  
Outcome  TimePoints 
Phase II- Coding of perinatal and neonatal deaths using the WHO ICD10 and ICD-PM.  131 weeks
October 2020-June 2023 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   15/10/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
INTRODUCTION
Perinatal deaths account for 7% of the global burden of disease. Accurate diagnosis of the cause of fetal, perinatal, and neonatal death is important for the prevention of deaths and morbidity in subsequent pregnancies. In fifty percent of the cases, the certified cause of death can be discordant from the actual cause of death and hence the need for a post-mortem examination. A conventional autopsy is a gold standard in confirming and establishing the cause of death in the perinatal and neonatal period especially when clinical manifestations are nonspecific. It includes a thorough examination of the whole body with dissection of organs and body cavities, followed by sectioning of relevant tissues to establish the cause of death and the effectiveness and side effects of therapies. India being a conservative multicultural nation, many parents refuse to consent for autopsy in neonates due to religious, emotional attachment, and cultural reasons. Public reluctance for autopsy has increased over time, more so due to adverse media attention, delay in last rites, and spiritual or ethnic views, and fear of disfigurement of the deceased’s body, has led to refusal for conventional autopsy and preferential acceptance for Minimally Invasive Tissue Sampling (MITS). It is a feasible and less traumatic technique that would circumvent the need for a complete autopsy in determining the cause of death. This technique is less invasive and time-consuming and practical in socially constrained areas. 

RESEARCH QUESTION
Can minimally invasive tissue sampling be an alternative to a conventional autopsy?

STUDY DESIGN
This is a three-year prospective and retrospective study conducted in the Departments of Pathology and Pediatrics (Neonatology) in Kasturba Medical College & Hospital, Manipal, Karnataka

The study is divided into two phases
  • Phase I – Qualitative study on community perceptions on conventional autopsy and MITS
  • Phase II – Prospective and retrospective study on minimally invasive tissue sampling and conventional autopsy to establish the cause of death (CoD)
OUTCOME EXPECTED
  • Phase I of the study - Thematic analysis of the interviews will reveal the perceptions regarding neonatal autopsy, causes of death of a neonate, willingness of the community to know the cause of death, and acceptance of MITS.
  • Phase II- Establishing the cause of death and coding of perinatal and neonatal deaths using the WHO ICD10 and ICD-PM.
IMPORTANCE OF THE RESEARCH
  • Establishing the cause of death
  •  Prevention of deaths and morbidity in subsequent pregnancies
  • The perceptions of the community towards autopsy practices are also important to improve neonatal mortality and recommend changes in health policies. 
  • Help in identifying the perceptions and acceptance of the community towards autopsy practices and the acceptance of MITS versus conventional autopsy in cases of neonatal deaths.

 
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