Health Condition 1: R688- Other general symptoms and signs
Conditions
Interventions
Control Intervention1: Blood culture guided antibiotics duration: The first Arm will include new born babies with suspected sepsis whose blood culture will be done and antibiotics will be given for a
Sponsors
CMC hospital Vellore
Eligibility
Inclusion criteria
Inclusion criteria: 1 Symptoms criteria a Apnea b Hyperthermia c Respiratory distress d Poor feeding e Lethargy f Irritability g Hypothermia h Hypotension i Poor perfusion j vomiting k Feed intolerance l Diarrhea m Seizures n Cyanosis 2 Laboratory criteria a Have a total WBC count more than 5000 per cubic millimeter b Have an Absolute Neutrophil Count more than 1500 per cubic millimeter 3 Baby becomes asymptomatic and are clinically well within 24 hours of suspicion of sepsis with following criteria a Normal activity b Stable temperature c Stable hemodynamic status with no need for inotropes d No respiratory support needed like supplementary oxygen CPAP ventilation
Exclusion criteria
Exclusion criteria: 1 They have received antibiotics in the past 15 days 2 They have had surgery in the past 7 days 3 Total WBC count less than 5000 per cubic millimeter 4 Have an Absolute Neutrophil Count less than 1500 per cubic millimeter 5 Abnormal activity beyond 24 hours of suspicion of sepsis 6 Unstable temperature beyond 24 hours of suspicion of sepsis 7 Unstable hemodynamic status requiring inotropes 8 Respiratory support needed like supplementary oxygen CPAP ventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All babies will be clinically reviewed 15 days after stopping antibiotics to look for any evidence of suspected sepsis Rates of restarting antibiotics for suspected sepsis within 15 days of stopping antibiotics in the two groups will be compared If babies have been discharged then this will be done over the phone with parents This will be also done in Out Patient Department for babies discharged or in the ward if still admitted Timepoint: 15 days after stopping antibiotics | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of antibiotic therapy Incidence of necrotizing enterocolitis within 28 days of stopping antibiotics Rates of restarting antibiotics for suspected sepsis within 28 days of stopping antibiotics In babies who are well and discharged then a phone call will be made at 28 days to check for any symptoms of sepsis or necrotizing enterocolitis Timepoint: 28 days after stopping antibiotics | — |
Countries
India
Contacts
Public ContactDr Santhanam Sridhar
Christian Medical College Vellore
Outcome results
None listed