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临床试验/CTRI/2020/12/029776
CTRI/2020/12/029776招募中未知

Optimizing place of treatment for young infants presenting with any low mortality risk sign of possible serious bacterial infection-Study 1 - PSBI RCT 1

Centre for Health Research and Development Society for Applied Studies0 个研究点目标入组 0 人开始时间: 待定最近更新:

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研究概览

简要总结

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研究设计

研究类型
Interventional

入排标准

入选标准

  • All young infants < 2months days old, living in a geographic area where follow-up for 14 days can be accomplished presenting to outpatient clinics or emergency rooms of participating hospitals will considered for inclusion in this study if they have ONLY one of the following low-risk signs of PSBI:
  • 1. Body temperature >=38°C, or
  • 2. Severe chest indrawing, or
  • 3. Fast breathing ( <7 days old infants).

排除标准

  • 1. Weight <2kg at the time of presentation (if age at screening is less than 10 days) or weight for age <-3z, or
  • 2. Signs of critical illness (no movement at all, unable to feed at all, convulsions), or
  • 3.Signs of CSI associated with a high risk of mortality (stopped feeding well, movement only on stimulation, low body temperature < 35.5oC or two or more of the six signs of CSI), or
  • 4. Any sign suggestive of another serious illness/condition, such as major congenital malformations, severe jaundice, conditions requiring major surgery, meningitis, bone or joint infection, severe dehydration, etc., or
  • 5. Appearance of low-mortality risk signs in first 24 hours of life , or
  • 6. Hospitalized for any illness in the previous 2 weeks, or
  • 7. Prior use of injectable antibiotics for the same illness, or
  • 8. Previously included in this study or currently included in any other study

研究者

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