Health Condition 1: P369- Bacterial sepsis of newborn, unspecified Health Condition 2: P379- Congenital infectious or parasiticdisease, unspecified Health Condition 3: P359- Congenital viral disease, unspecified Health Condition 4: P399- Infection specific to the perinatal period, unspecified
Conditions
Interventions
Intervention1: 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
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Objectives 2 and 3: Autolysed or macerated neonates Objective 1: Those who are not consented
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective 3: Able to standardize the MITS protocol for intestinal sampling using 20 casesTimepoint: May 2024 to May 2025 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: May 2024 to May 2027 | — |
Countries
India
Contacts
Public ContactDr Mary Mathew
Kasturba Medical College,Manipal Manipal Academy of Higher Education
Outcome results
None listed