Choice of Antibiotics for the Treatment of Infection in Newborns
- Conditions
- Health Condition 1: P369- Bacterial sepsis of newborn, unspecified
- Registration Number
- CTRI/2021/08/035803
- Lead Sponsor
- Banaras Hindu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
1. Newborns receiving antibiotics for 3 days or less
2. Major congenital malformations
3. Failure to obtain consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment failure will be defined as a need for changing initial antibiotics regimen within 72 hours or earlier if treating physician considers it necessary in view of rapidly deteriorating clinical condition of newbornTimepoint: Within 72 hours
- Secondary Outcome Measures
Name Time Method 1. Death at 3 days of age <br/ ><br>2. Death at 7 days of age <br/ ><br>3. Death at 1 month of age <br/ ><br>4. Adverse effects of therapyTimepoint: 3 days, 1 week and 1 month