DEVELOPMENT OF A COMPREHENSIVE PERINATAL AND NEONATAL PREDICTIION MODEL FOR EARLY ONSET SEPSIS IN PRETERM NEONATES BORN LESS THAN OR EQUAL TO 34 WEEKS OF GESTATION – A PROSPECTIVE COHORT STUDY
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Lady Hardinge Medical College NewDelhi
- Enrollment
- 1,180
- Locations
- 1
- Primary Endpoint
- Development of a “comprehensive perinatal and neonatal prediction model“
Overview
Brief Summary
• Most of the currently available early onset sepsis risk calculators are based on perinatal risk factors and are derived from the data collected in developed countries, which has altogether different organism profile (gram positive>> gram negative in former), clinical course, and outcome than developing countries and risk factor based approach leads to unnecessary exposure of antibiotics during the 1st week of life among asymptomatic neonates. Hence this prospective cohort study is aimed to develop comprehensive perinatal risk factor and neonatal clinical parameter based prediction model for early onset neonatal sepsis for babies born ≤ 34 weeks of gestation in developing country like India.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 0.00 Day(s) to 3.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •All neonates born with ≤34 weeks of gestation.
Exclusion Criteria
- •Major congenital anomaly (antenatally diagnosed or visible at birth).
Outcomes
Primary Outcomes
Development of a “comprehensive perinatal and neonatal prediction model“
Time Frame: Till discharge or death which ever is earlier
Secondary Outcomes
- 1.Performance of model for culture positive sepsis(2.Performance of model for probable sepsis)
Investigators
DR SUSHMA NANGIA
Lady hardinge medical college