Health Condition 1: P369- Bacterial sepsis of newborn, unspecified
Conditions
Interventions
Intervention1: SPE: In this group the baby who is asymptomatic and is at risk of EOS will be admitted in NICU, serially examined with the parameters as mentioned in the SPE table, for a duration of 48
Sponsors
NONE
Eligibility
Inclusion criteria
Inclusion criteria: All newborns greater than equal to 35 weeks but less than 42 weeks gestation born at AIIMS Nagpur, who are well appearing at birth and are at risk of early onset sepsis, provided they do not meet the exclusion criteria (risk factors for early onset sepsis will be defined as per our unit protocol which have been modified from NICE guidelines as mentioned below).
Exclusion criteria
Exclusion criteria: Exclusion criteria a) Parents or guardians unwilling to provide consent for the study. b) All suspected cases of congenital malformations, genetic diseases or chromosomal disorders. c) All neonates who are non-vigorous at birth, require neonatal resuscitation or are symptomatic for EOS within 1 hour of birth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of neonates receiving antibiotics and proportion of neonates undergoing sepsis workupTimepoint: Day 1, Day 2, Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Reduction in mean antibiotic-therapy days/100 patient days 2) Median length of hospital stay 3) Median time to detect symptomatic EOS cases 4) Rate of re-admission with suspected sepsis following discharge 5) Incidence of Culture-positive sepsis (Culture-positive EOS was defined by growth of bacteria in a blood culture. Growth of coagulase-negative staphylococci in a single blood culture was considered as contamination) 6) Incidence of infection-attributable mortality (Infection-attributable mortality will be those deaths which would occur when the neonate had developed clinical signs/symptoms of sepsis with laboratory investigations being positive prior to the death)Timepoint: Day 1, 7 , 28 | — |
Countries
India
Contacts
Public ContactDR NISHANT BANAIT
AIIMS NAGPUR
Outcome results
None listed