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eonatal sepsis in district hospitals in India

Not Applicable
Conditions
Health Condition 1: - Health Condition 2: B96- Other bacterial agents as the cause of diseases classified elsewhere
Registration Number
CTRI/2019/10/021720
Lead Sponsor
All India Institute of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. All neonates (inborn and outborn) admitted in the SNCUs of the district hospitals

2. Postnatal age less than or equal to 28 days

Exclusion Criteria

Parents not willing to participate in the study

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of early onset sepsis and late onset sepsis, and culture positive and culture negative sepsis (inborn neonates) <br/ ><br>Prevalence of culture positive and culture negative sepsis (outborn neonates) <br/ ><br>Mortality â?? all cause as well as sepsis-related mortality <br/ ><br>Profile of organisms isolated <br/ ><br>Antimicrobial resistance pattern <br/ ><br>Details of antibiotic therapy <br/ ><br>Molecular characterization of virulence factors and resistance genes <br/ ><br>Timepoint: 28 days
Secondary Outcome Measures
NameTimeMethod
Mortality â?? all cause as well as sepsis-related mortality; <br/ ><br>Profile of organisms isolated; <br/ ><br>Antimicrobial resistance pattern; <br/ ><br>Details of antibiotic therapy; <br/ ><br>Molecular characterization of virulence factors and resistance genes; <br/ ><br>Timepoint: up to 28 days of life
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