CTRI/2016/06/007056尚未招募未知
A RANDOMISED CONTROLLED TRIAL COMPARING SAFETY AND EFFICACY OF SHORT COURSE VERSUS CRP GUIDED ANTIBIOTIC REGIMEN FOR BLOOD CULTURE NEGATIVE SUSPECTED NEONATAL SEPSIS - CRISS
Christian Medical College Hospital Vellore0 个研究点目标入组 220 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
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
- •Newborn babies who have any of the following symptoms of sepsis will have a blood count, blood culture done and started on appropriate antibiotics if the treating clinician feels that it is consistent with a diagnosis of suspected sepsis. The symptoms of sepsis are: Apnea, Hyperthermia, Respiratory distress, Poor feeding, Lethargy, Irritability, Hypothermia, Hypotension, Poor perfusion, vomiting, Feed intolerance, Diarrhea, Seizures, Cyanosis.
- •They will be included in the study if they fulfill the following criteria:
- •i.Become asymptomatic and are clinically well. within 24 hours of suspicion of sepsis. Babies are deemed to be clinically well if they satisfy the following clinically criteria:
- •1.Normal activity
- •2.Stable temperature
- •3.Stable hemodynamic status with no need for inotropes
- •4.No respiratory support needed (supplementary oxygen, CPAP, ventilation)
- •ii.Have a total WBC count > 5000/cu.mm
- •iii.Have an Absolute Neutrophil Count >1500/cu.mm
- •iv.Have an immature: total neutrophil ratio of <0.2
- •v.Have a sterile blood culture 48 hours after inoculation
排除标准
- •a)They have received antibiotics in the past 15 days
- •b)They have had surgery in the past 7 days
研究者
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