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Clinical Trials/CTRI/2020/10/028289
CTRI/2020/10/028289
Not yet recruiting
未知

Minimally Invasive Tissue Sampling and Conventional Autopsy in Establishing Cause of Death in the Neonatal Period - MITS-CAi

A0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
A
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
A

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Phase I: Unmarried adults of any gender
  • Phase II: Macerated babies and fetuses.

Outcomes

Primary Outcomes

Not specified

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