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Minimally Invasive Tissue Sampling and Postmortem Examination to Know the Cause of Death in Babies with 30 days of Age

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028289
Enrollment
150
Registered
2020-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P399- Infection specific to the perinatal period, unspecified Health Condition 2: P549- Neonatal hemorrhage, unspecified Health Condition 3: P84- Other problems with newborn Health Condition 4: P968- Other specified conditions originating in the perinatal period Health Condition 5: P220- Respiratory distress syndrome of newborn Health Condition 6: P279- Unspecified chronic respiratory disease originating in the perinatal period

Interventions

Intervention1: 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 pr

Sponsors

None listed

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Phase I- 72 weeks January 2021-June 2022 Phase II- 131 weeks October 2020-June 2023—

Secondary

MeasureTime frame
Phase II- Coding of perinatal and neonatal deaths using the WHO ICD10 and ICD-PM.Timepoint: 131 weeks October 2020-June 2023—

Countries

India

Contacts

Public ContactDrMary Mathew

Kasturba Medical College, Manipal

marymathew883@gmail.com9845678806

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026