Health Condition 1: P369- Bacterial sepsis of newborn, unspecified
Conditions
Interventions
Intervention1: Biofire: Blood culture will be obtained from asymptomatic neonate presents with perinatal risk factors for early onset sepsis. Blood sample of 1 mL will be drawn and inoculated into a 4
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Asymptomatic neonates with perinatal risk factors of sepsis and being initiated on empirical antibiotic therapy based on the unit protocol
Exclusion criteria
Exclusion criteria: 1.Neonates enrolled in other concurrent study on early-onset sepsis 2.Parental refusal to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Agreement between the results of Biofire and blood culture in terms of a. Culture positivity/ negativity b. Organism profile and antimicrobial resistance (AMR) Timepoint: When the report of Biofire is available (approximately 24hrs), when the blood culture report is available (approximately 72hrs) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration (hours) of antibiotic usage 2. Treatment failure, as defined by the presence of one or more of a. Need for continuation of antibiotics in the first week of life (based on blood culture report or the clinical team s discretion) b. Need for reinitiation of antibiotics in the first week of life c. Need for upgradation of antibiotics in the first week of life d.Sepsis -related death in the first 7 days of life Timepoint: 7 days | — |
Countries
India
Contacts
Public ContactNarreddy Manvitha
AIIMS New Delhi
Outcome results
None listed