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临床试验/ISRCTN15622505
ISRCTN15622505未知未知

Children’s Oxygen Administration Strategies Trial (COAST): a randomised controlled trial of high flow versus oxygen versus control in African children with severe pneumonia

Imperial College, London (UK)0 个研究点目标入组 1,852 人开始时间: 2016年2月20日最近更新:

试验速览

阶段
未知
发起方
入组人数
1,852

研究概览

简要总结

2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/29383331/ protocol

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Aged between 28 days to 12 years
  • 2. History of respiratory illness (cough, upper respiratory tract symptom or any respiratory symptoms, e.g. rapid breathing or increase work of breathing)
  • 3. Hypoxia (pulse oximetry reading of SaO2 <92% recorded in room air over 5 minutes)
  • 4. Plus any one of the following signs of severe pneumonia (from 2013 WHO clinical definitions for pneumonia):
  • 4.1.Sign of respiratory distress (any one of):
  • 4.1.1. Severe lower chest wall in-drawing
  • 4.1.2. Use of auxiliary muscles
  • 4.1.3. Head nodding
  • 4.1.4. Inability to feed because of respiratory problems
  • 4.2. Suspected pneumonia
  • 4.2.1. Fast breathing:
  • 4.2.1.1. Age 2–11 months: = 50/minute
  • 4.2.1.2. Age 1–5 years: = 40/minute
  • 4.2.1.3. Age 5-12 years = 30/minute
  • 4.2.2. Chest auscultation signs:
  • 4.2.2.1. Decreased breath sounds
  • 4.2.2.2. Bronchial breath sounds
  • 4.2.2.3. Crackles
  • 4.2.2.4. Abnormal vocal resonance (decreased over a pleural effusion or empyema, increased over lobar consolidation)
  • 4.2.2.5. Pleural rub
  • 4.3. Signs of pneumonia with a general danger sign:
  • 4.3.1. Inability to breastfeed or drink
  • 4.3.2. Lethargy or unconscious
  • 4.3.3. Convulsions

排除标准

  • 1. Known uncorrected cyanotic heart disease
  • 2. Assent/consent refusal by parent/carer
  • 3. Previously recruited to COAST
  • 4. Already received oxygen for this episode of illness

研究者

发起方
Imperial College, London (UK)

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