A randomised controlled trial of high flow versus oxygen versus control in African children with severe pneumonia
- Conditions
- Severe pneumonia in African childrenInfections and Infestations
- Registration Number
- ISRCTN15622505
- Lead Sponsor
- Imperial College, London (UK)
- Brief Summary
2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/29383331/ protocol
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 1852
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method