Health Condition 1: P369- Bacterial sepsis of newborn, unspecified Health Condition 2: null- Suspected Neonatal sepsis where blood culture is negative
Conditions
Interventions
Intervention1: Group A: Stopping antibiotics at 72 hours if blood culture is sterile without any further testing
Control Intervention1: Group B: Doing a CRP and deciding duration of antibiotics based
Sponsors
Christian Medical College Hospital Vellore
Eligibility
Inclusion criteria
Inclusion criteria: Newborn babies who have any of the following symptoms of sepsis will have a blood count, blood culture done and started on appropriate antibiotics if the treating clinician feels that it is consistent with a diagnosis of suspected sepsis. The symptoms of sepsis are: Apnea, Hyperthermia, Respiratory distress, Poor feeding, Lethargy, Irritability, Hypothermia, Hypotension, Poor perfusion, vomiting, Feed intolerance, Diarrhea, Seizures, Cyanosis. They will be included in the study if they fulfill the following criteria: i. Become asymptomatic and are clinically well. within 24 hours of suspicion of sepsis. Babies are deemed to be clinically well if they satisfy the following clinically criteria: 1. Normal activity 2. Stable temperature 3. Stable hemodynamic status with no need for inotropes 4. No respiratory support needed (supplementary oxygen, CPAP, ventilation) ii. Have a total WBC count > 5000/cu.mm iii. Have an Absolute Neutrophil Count >1500/cu.mm iv. Have an immature: total neutrophil ratio of v. Have a sterile blood culture 48 hours after inoculation
Exclusion criteria
Exclusion criteria: a) They have received antibiotics in the past 15 days b) They have had surgery in the past 7 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of restarting antibiotics for suspected sepsis within 15 days of stopping antibiotics in the two groups will be compared.Timepoint: Rates of restarting antibiotics for suspected sepsis within 15 days of stopping antibiotics in the two groups will be compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of antibiotic therapyTimepoint: Days from starting antibiotics;Incidence of necrotizing enterocolitis within 28 days of stopping antibioticsTimepoint: 28 days of stopping antibiotics;Rates of restarting antibiotics for suspected sepsis within 28 days of stopping antibioticsTimepoint: 28 days of stopping antibiotics | — |
Countries
India
Contacts
Public ContactBenjamin Jeyanth Ross
Christian Medical College, Vellore
Outcome results
None listed