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

Phase 3

• Conditions: Bronchiolitis; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12613000316707
• Lead Sponsor: Royal Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-20
• Study Completion: 2019-11-24
• Last Update Posted: 2 November 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 211

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

Exclusion Criteria

Corrected gestational age of less than 37 weeks at time of admission to the intensive care.
Clinical evidence of croup (laryngotracheobronchitis)
Immunosuppressive treatment, including any dose of corticosteroids in the last 7 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).[Duration of intensive care stay - only at the conclusion of the intensive care stay will this outcome be evaluated]

Secondary Outcome Measures

Name	Time	Method
1Duration 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[Duration of intensive care stay];Intensive care length of stay<br>[at discharge from intensive care];Hospital length of stay[at discharge from hospital];Rate of intubation – the number of children admitted to the intensive care units that require endotracheal intubation<br>[end of intensive care 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.<br>[duration of intensive care stay]