Health Condition 1: P369- Bacterial sepsis of newborn, unspecified
Conditions
Interventions
Intervention1: Short course antibiotics: Mostly started with IV Ampicillin and @100-150mg/kg/day divided in 2 or 3 doses depending upon age and weight and IV Amikacin @15-18mg/kg given once in 24,36 o
Sponsors
AIIMS Raipur
Eligibility
Inclusion criteria
Inclusion criteria: 1.Neonates aged 0-28days, who are currently admitted to the neonatal unit of AIIMS RAIPUR. 2.Birth weight >1000g 3.Suspected septicemia for which a blood culture is sent and for which the treating clinician decides to start antibiotics
Exclusion criteria
Exclusion criteria: 1.Central Nervous System infection (meningitis will be defined as one or more cerebrospinal fluid (CSF) cell count >25 microliters with >60% neutrophils: glucose 150 mg/dl in term or >180mg/dl in preterm or positive gram stain report or positive report culture. 2.Septic arthritis, osteomyelitis, or deep-seated abscess as clinically judged by the treating team 3.Life-threatening congenital malformations as judged by the principal investigator of the center.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Definite or probable relapse. Definite relapse is defined as the occurrence of an episode of illness within the 21 days after antibiotic completion in which the same organism with a similar antibiogram is grown as the original episode. Probable relapse is defined as the occurrence of an episode of illness within 21 days, when an episode is diagnosed to be a relapse of bacterial sepsis based on clinical features and investigations, in the setting of sterile blood culture. Probable relapse is adjudicated by a blinded pediatrician/neonatologist who is not associated with the rest of the study.Timepoint: 21days | — |
Secondary
| Measure | Time frame |
|---|---|
| Definate or probable relapse within 21 or 28 days after antibiotic completion , 2. Definate or probable relapse 28 or 35 days after randomization.Timepoint: 28 or 35 days after randomization. | — |
Countries
India
Contacts
Public ContactDr Ayushie Jain
AIIMS Raipur
Outcome results
None listed