Comparison of Ampicillin plus Gentamicin versus Co-amoxyclav plus Amikacin for the Treatment of Neonatal Sepsis: A Randomized Controlled Trial

Banaras Hindu University0 个研究点目标入组 315 人开始时间: 待定最近更新: 2022年10月17日

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•Clinical Symptoms (2 or more)
•1 If core body temperature more than 38.5Ã?Â°C or less than 36Ã?Â°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

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