Extrait

Background and study aims Although giving oxygen is a basic element of hospital care, this treatment is costly and supplies are inadequate and erratic in African hospitals. The aim of this study is to identify which children would benefit from receiving oxygen and what would be the best delivery method. Who can participate? Children aged between 28 days and 12 years with a history of respiratory illness, hypoxia (lack of adequate oxygen supply) and signs of severe pneumonia (lung inflammation). What does the study involve? This study examines whether or not giving oxygen improves patient outcomes. For children with hypoxia, it is not certain what the best level to provide oxygen is and whether this results in a better outcome. The children with less severe hypoxia are randomly allocated to either receive oxygen or not. The children with more severe hypoxia all receive oxygen as we are more confident about the benefits of oxygen in this group. The children receiving oxygen are randomly allocated to receive oxygen either at a higher flow or at a lower flow (routine care). High flow oxygen provides extra pressure to the airways to prevent them from collapsing after every exhale. This helps reduce the effort of breathing, which is vital when lung infections can often lead to respiratory exhaustion and ultimately respiratory failure in critically sick children with limited access to relevant life support such as mechanical ventilation (the majority of hospitals in Africa). What are the possible benefits and risks of participating? The direct benefits to the child and/or family include: 1. Closer observation during the first 48 hours of admission, which, as a result, allows doctors and nurses to make important changes to the child’s treatment during in-hospital admission. 2. All routine non-trial medications required by the hospital to treat the child will be made available (when unavailable parents have to resort to sourcing these privately). All blood tests will be covered by the trial. 3. Reimbursement for transport cost after discharge and for follow up visits plus any treatment costs required during the visits will be made. Snacks and drinks will be provided at each follow up visit. High flow is an accepted strategy in the management of children with respiratory failure in a multitude of countries, with few reports that it is unacceptable, so the risks of harm from this strategy are known and are extremely low. Where is the study run from? 1. Coast Provincial General Hospital, Mombasa (Kenya) 2. KEMRI Wellcome Trust Programme (Kenya) 3. Mulago Hospital (Uganda) 4. Mbale Regional Referral Hospital (Uganda) 5. Soroti Regional Referral Hospital (Uganda) When is the study starting and how long is it expected to run for? December 2016 to November 2019 Who is funding the study? Joint Global Health Trials scheme (Medical Research Council, Department for International Development and Wellcome Trust) Who is the main contact? 1. Prof Kathryn Maitland ([email protected]) 2. Mr Ayub Mpoya ([email protected])

Critère d'inclusion

• Severe pneumonia in African children

Liens

• ictrp
• isrctn