CTRI/2023/08/056272尚未招募Unknown
Comparision of Levofloxacin and Amikacin versus Piperacillin-tazobactam and Amikacin for the Treatment of Neonatal Sepsis: A Randomized Controlled Trial - NI
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •The diagnosis of neonatal sepsis will be based on the presence of the following criteria, as defined by the European Medicines Agency (2010). Per EMA criteria there should be at least 2 clinical and 2 laboratory signs for making a diagnosis of suspected or confirmed neonatal sepsis. These criteria are as follows:
- •Clinical symptoms (2 or more)
- •1.If core body temperature >38.5°C or <36°C or temperature instability.
- •2.Cardiovascular instability: Bradycardia, (heart rate <80/min),Tachycardia (heart rate >180/min),Rhythm instability,Reduced urine output ( <1ml/kg/hour),Hypotension requiring volume or inotropic support,Mottled skin, Capillary refilling time >3 seconds
- •3.Respiratory instability: Apnea (cessation of breathing for >20 seconds),Tachypnea (respiratory rate >60/min, Increased oxygen requirement >10%, Requirement of ventilatory support
- •4.Petechial rash or sclerema.
- •5.Feed intolerance or poor sucking or abdominal distension.
- •6.Central nervous system:Irritability, Lethargy, Hypotonia, Seizure
- •7.Cellulitis or skin ulceration.
- •8.Non-specific: irritability or lethargy or hypotonia
- •Laboratory signs (2 or more)
- •1.White blood cells (WBC) count <4,000/cubic mm or >20,000/cubic mm.
- •2. Platelet count <100,000/cubic mm
- •3.Immature to total neutrophil ratio >0.2
- •4. C-reactive protein >10 mg/L
- •5.Glucose intolerance confirmed at least 2 times: hyperglycemia (blood glucose >180 mg/dL or 10mmol/L) or hypoglycemia (blood glucose <45mg/dL or 2.5 mmol/L).
- •6.Metabolic acidosis: Base excess (BE) below -10 mEq/L or Serum lactate >2 mmol/L.
- •7.Chest X-ray suggestive of bronchopneumonia
- •8.Cerebrosinal fluid changes suggestive of septic meningitis.
排除标准
- •1.Newborns receiving prophylactic antibiotics
- •2.Surgical conditions and life threatening congenital malformations
- •3.Failure to obtain consent
- •4.Prior exposure of antibiotics
研究者
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