CTRI/2021/08/035803招募中未知
Efficacy and Safety of Ampicillin and Gentamicin versus Piperacillin-tazobactam and Amikacin for the Treatment of Neonatal Sepsis: A Randomized Controlled Trial
试验速览
- 阶段
- 未知
- 状态
- 招募中
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
- •Clinical Symptoms (2 or more)
- •1 If core body temperature more than 38.5Ã?°C or less than 36Ã?°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
排除标准
- •1. Newborns receiving antibiotics for 3 days or less
- •2. Major congenital malformations
- •3. Failure to obtain consent
研究者
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