Health Condition 1: P369- Bacterial sepsis of newborn, unspecified
Conditions
Interventions
Intervention1: Injection Co-amoxyclav and Amikacin: Injection Co-amoxyclav and Amikacin will be administered intravenously in suspected neonatal sepsis using standard doses for newborns adjusted to ge
Sponsors
Banaras Hindu University
Eligibility
Inclusion criteria
Inclusion criteria: Clinical Symptoms (2 or more) 1 If core body temperature more than 38.5�°C or less than 36�°C or temperature instability. 2 Cardiovascular instability: bradycardia(heart rate below 80/minute) or tachycardia(heart rate above 180/minute) or reduced urinary output (less than 1 ml/kg/hour)or hypotension requiring volume or inotropic support, or mottled skin or capillary refilling time more than 3 seconds 3 Respiratory instability: apnea(cessation of breathing for more than 20 seconds) or tachypnea(respiratory rate more than 60/minute)or episodes or increased oxygen requirement by more than 10% or requirement of ventilatory support 4 Petechial rash or sclerema 5 Feeding intolerance or poor sucking or abdominal distension 6 Central nervous system: irritability or lethargy or hypotonia or seizures 7 Cellulitis or skin ulceration Laboratory signs (2 or more) 1 White blood cells (WBC) count: below 4,000/cubic mm or above 20,000 cubic mm 2 Platelet count below 100,000 cubic mm 3 Immature to total neutrophil ratio above 0.2 4 C reactive protein above 10 mg/L or Procalcitonin levels above hourly reference values after birth 5 Glucose intolerance: hyperglycemia (blood glucose above 180 mg/dL) or hypoglycemia (blood glucose below 45mg/dL) 6 Metabolic acidosis: Base excess (BE) below -10 mEq/L or Serum lactate above 2 mMol/L 7 Chest xray suggestive of bronchopneumonia 8 Cerebrospinal fluid changes suggestive of septic meningitis
Exclusion criteria
Exclusion criteria: 1 Newborns receiving antibiotics for 3 days or less for rule out sepsis 2 Surgical conditions and major congenital anomalies 3 Failure to obtain consent 4 Receipt of antibiotics prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure will be defined as a need for change of initial antibiotic regimen within 72 hours of enrollment, or earlier if treating physician considers it necessary, or not cured by day 7 after enrollment.Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Death at 3 days of age 2. Death at one week of age 3. Death at one month of age 4. Adverse effects of drug therapy Timepoint: 3 days, 1 week and 1 month | — |
Countries
India
Contacts
Public ContactSuman Kumari
Banaras Hindu University
Outcome results
None listed