DAB Trial Dataset
The University of MelbourneDataset description
These data are from 211 children enrolled in an open label randomised trial of corticosteroids and inhaled adrenaline vs standard care alone in children with bronchiolitis admitted to four paediatric intensive care units in Australia and New Zealand. The data include treatment arm, demographic and clinical characterisitcs and respiratory outcomes.Subjects
Infant and child health |Identifiers
Source Study
Trial name (public)
Randomised controlled trial of a combination of Dexamethasone and Adrenaline for infants with BronchiolitisTrial acronym
DAB
Trial ID
ACTRN12613000316707
Purpose
Treatment
Phase
Phase 3
Funding
Hospital,Paediatric Intensive Care Unit (PICU) Royal Children/s Hospital(RCH) Melbourne
Scientific enquiries
Dr Ben Gelbart
Brief Summary
Bronchiolitis is a common viral infection of the lungs. It is mostly seen in children less than 1 year old, but it does affect children up to 2 years of age. Each year an average of 100 children with severe bronchiolitis need to be admitted for treatment in the intensive care unit. These children experience significant breathing difficulty and many are ill enough to need a machine to help them to breathe. The standard treatment for these children is to support their breathing, and to give them a .... Read more
Key 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 .... Read more
Key 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.
Can healthy volunteers participate?
No
Population
Sample Size 211
Min. age 37 Weeks
Max. age 18 Months
Sex Both males and females
Condition category Bronchiolitis
Condition code Infection , Respiratory
Intervention
Intervention code Treatment: Drugs
While in intensive care, patients in the treatment group will receive 0.6 mg/kg dexamethasone intramuscular or intravenously OR 4mg/kg of oral prednisolone 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 nasogas .... Read more
Comparison
Control group Active
Standard therapy for bronchiolitis usually comprises oxygen therapy, positive pressure respiratory support administered by a gas flow device or mechanical ventilator, nutritional support and sedation. Both arms will receive these therapies. Once recruited and randomised, patients will be given either a combination of corticosteroids plus nebulised adrenaline in addition to standard therapy, or standard therapy alone as determined by their random allocation. Dexamethasone and adrenaline are medic .... Read more
Outcomes
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).Timepoint: Duration of intensive care stay - only at the conclusion of the i .... Read more
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
demographic data - age, sex, comorbidities microbiological data respiratory support data - respiratory support types, duration PICU and hospital length of stay
When will data be available?
after publication of the manuscript anticipated to be after July 2021 The data will be available for 5 years
Available to whom?
Researchers with methodologically sound ethics committee approved research protocols
Available for what types of analyses?
only to achieve the aims of the approved protocol