Minimally Invasive Tissue Sampling and Postmortem Examination to Know the Cause of Death in Babies with 30 days of Age
- Conditions
- Health Condition 1: P399- Infection specific to the perinatal period, unspecifiedHealth Condition 2: P549- Neonatal hemorrhage, unspecifiedHealth Condition 3: P84- Other problems with newbornHealth Condition 4: P968- Other specified conditions originating in the perinatal periodHealth Condition 5: P220- Respiratory distress syndrome of newbornHealth Condition 6: P279- Unspecified chronic respiratory disease originating in the perinatal period
- Registration Number
- CTRI/2020/10/028289
- Lead Sponsor
- A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Phase I: Unmarried adults of any gender
Phase II: Macerated babies and fetuses.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method