Health Condition 1: P369- Bacterial sepsis of newborn, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Indian Council of Medical Education and Research (ICMR)
Eligibility
Inclusion criteria
Inclusion criteria: Inborn or outborn neonates admitted to any of the participating neonatal units with clinical suspicion of early-onset or late-onset sepsis. "Clinical suspicion of sepsis" will be defined per the NeoObs study enrollment criteria. The decision to perform laboratory tests would be left to the treating team and no mandatory laboratory tests will be performed as a part of the screening process for the current study. Neonates will be diagnosed with clinically suspected sepsis if at least two criteria are positive, of which at least one has to be a clinical criterion. Postnatal age less than or equal to 28 days.
Exclusion criteria
Exclusion criteria: 1. Serious congenital malformation or 2. Critical illness or end-of-life care support that restricts sample collection for laboratory evaluation. Parents of neonates who meet the above eligibility criteria will be approached for participation in the study. They will be provided with a parent information sheet. Neonates will be enrolled after obtaining written informed consent from a parent. Information from enrolled neonates will be gathered on a case report form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate NGS Detection of Pathogens & ARGs Sensitivity, SpecificityTimepoint: At presentation/baseline: Immediately upon clinical suspicion of neonatal sepsis and sample collection. Within 12 hours of sample collection: Assessment of rapid identification of pathogens and antibiotic resistance genes using NGS. Baseline, within 12 24 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Identification of the spectrum of pathogens (bacterial and fungal) responsible for neonatal sepsis across participating tertiary care centers. Detection and characterization of antimicrobial resistance genes (ARGs) associated with neonatal sepsis. Impact of NGS-based results on clinical management, including time to initiation of appropriate antimicrobial therapy.Timepoint: Upon completion of NGS analysis for each enrolled neonate. | — |
Countries
India
Contacts
Public ContactSourabh Dutta
Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh
Outcome results
None listed