Health Condition 1: P35-P39- Infections specific to the perinatal period
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Bharati Hospital and Research Centr
Eligibility
Inclusion criteria
Inclusion criteria: All Neonates (0 to 28 days) admitted to NICU during the study period and clinically suspected to have sepsis by the treating neonatal physician.
Exclusion criteria
Exclusion criteria: Neonates (0 too 28 days) with the following conditions will be excluded from the study: 1. Major congenital anomalies incompatible with life 2. Blood culture not taken before starting antibiotics 3. Prior sepsis episode during the same admission and patient still not recovered 4. Only the first episode of sepsis for each patient will be included for analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rates of major organ dysfunction between neonates with culture-negative (probable) and culture-positive (proven) sepsis admitted to the NICU.Timepoint: Occurrence of any one or more of the Major organ dysfunction after the time of sepsis diagnosis, until the end of antimicrobial course, or 21 days, whichever is later. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the following between neonates with culture-negative versus and culture-positive sepsis: 1. Cause-specific mortality and 28-day all-cause mortality 2. Number of major organ dysfunction secondary to sepsis 3. Morbidity rates other than major organ dysfunction 4. Antibiotic exposure patterns (duration, escalation, de-escalation, prolonged empirical use). 5. Relapse of sepsis within 72 hours of discontinuation of antimicrobial therapy. 6. Severity of illness (peak n-SOFA score) during the course of sepsisTimepoint: Occurrence of secondary outcome after the time of sepsis diagnosis, until the end of antimicrobial course, or 21 days, whichever is later. | — |
Countries
India
Contacts
Public ContactRaghvendra Singh Patel
Bharati hospital and research centre
Outcome results
None listed