Randomised controlled trial of a combination of Dexamethasone and Adrenaline for infants with Bronchiolitis

INTERVENTION: While in intensive care, patients in the treatment group will receive 0.6 mg/kg dexamethasone intramuscular or intravenously as a loading dose, then 1 mg/kg of methylprednisolone intravenous or prednisolone nasogastric or orally 8 hourly for 9 doses (days1‐3 of the study), then daily for three days (days 4‐6). The route of administration is determined by the presence of an intravenous cannula or tolerance of oral intake for drugs that can be administered by nasogastric tube. This will be determined by the treating clinician. Starting at the same time as the loading dose of dexamethasone, patients will be given adrenaline providing the resting heart rate is <180 beats per minute: If eligible 5 doses of 0.05ml/kg of 1% adrenaline (or 0.5ml/kg of 1/1000 adrenaline) made up to 6ml with 0.9% saline and nebulised using 12L/min of 02 and repeated every 30 minutes to a total of 5 doses, then given 1‐4 hourly depending on the patient response for 72 hours, and then as required for a further 3 days while in intensive care. These drugs were chosen as they are commonly used for other inflammatory diseases of the airway of children and have been used in a recent randomised controlled trial in Canadian emergency department for this condition CONDITION: Bronchiolitis PRIMARY OUTCOME: The study’s primary outcome is the duration of non‐invasive or invasive positive pressure support required from the time of admission to the study until discharge from intensive care. Positive pressure ventilation includes therapies such as high flow nasal prong oxygen of 1 L/kg/min, nasopharyngeal continuous positive airway pressure (CPAP) or invasive positive pressure ventilation (IPPV). SECONDARY OUTCOME: 1 Duration of mechanical ventilation – these data are recorded and updated on an hourly basis in the intensive care observation charts which are part of the medical record Hospital length of stay Intensive care length of stay ; Pressure‐rate product if a nasogastric tube tube is already in situ. The pressure‐rate product is a way of measuring the strain on the lung. The pressure can be estimated by measuring the transmitted pressure through an existing routinely placed nasogastric tube and then multiplied by the patients respiratory rate. The Pressure‐rate product will be measured within the first 24 hours of respiratory support. ; Rate of intubation – the number of children admitted to the intensive care units that require endotracheal intubation ; INCLUSION CRITERIA: a clinical diagnosis of bronchiolitis, defined as a first or second episode of wheezing or respiratory distress associated with a respiratory tract infection plus either radiological evidence of chest hyperinflation or clinical evidence of prolonged expiration greater than 37 weeks and less than 18 months of age no previous admission to this study admission to intensive care for respiratory distress (not apnoea alone) recruitment and initiation of the study therapy within 4 hours of admission to intensive care