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临床试验/CTRI/2021/08/035803
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

Banaras Hindu University0 个研究点目标入组 0 人开始时间: 待定最近更新:

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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