Severe pneumonia in African children Infections and Infestations
Conditions
Interventions
The trial has two strata:
Stratum 1: severe hypoxia, SaO2 <80%)
and Stratum 2: hypoxia SaO2 =80% and <92%).
Children in Stratum 1 (2-arm, 1:1 ratio) will all receive oxygen and randomisation will allocate participants to one of two methods of oxygen delivery:
1.
Sponsors
Imperial College, London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality at 48 hours post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment failure at 48 hours 2. Survival to 28 days 3. Neurocognitive sequelae at 28 days 4. Disability-free survival to 28 days 5. Time to hypoxia (=92%) resolution during initial hospital stay 6. Length of initial hospital stay 7. Re-admission to hospital by 28 days 8. Anthropometric status by 28 days 9. Resolution of neurocognitive sequelae at 90 days (for those with neurocognitive sequelae at 28 days) | — |
Countries
Kenya, Uganda
Contacts
Public ContactHellen Mnjalla
Outcome results
None listed