Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000608369
Ethics application status
Approved
Date submitted
29/10/2008
Date registered
4/12/2008
Date last updated
29/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of aminophylline for infants less than 12 months of age with bronchiolitis, requiring admission to intensive care
Scientific title
Randomised, double-blind, placebo-controlled trial of aminophylline in infants less than 12 months of age with bronchiolitis who require intensive care, to assess if aminophylline is superior to placebo in reducing the duration of ventilatory support.
Secondary ID [1] 288449 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 3895 0
Condition category
Condition code
Infection 4093 4093 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aminophylline will be given, as a continuous infusion, for 3 days (72 hours) or until discharge from the Intensive Care Unit, whichever is sooner
Intervention code [1] 3620 0
Treatment: Drugs
Comparator / control treatment
Placebo (normal saline) will be given, as continuous infusion, for 3 days (72 hours) or until discharge from the Intensive Care Unit, whichever is sooner
Control group
Placebo

Outcomes
Primary outcome [1] 4988 0
Duration of respiratory support (mechanical ventilation or nasal continuous positive pressure). This information will be recorded manually by the treating physician on documentation provided.
Timepoint [1] 4988 0
5 days (120 hours) from admission to ICU, or until discharge from the Intensive Care Unit: whichever is sooner.
Secondary outcome [1] 8421 0
Length of stay in the Intensive Care Unit. This information will be recorded manually by the treating physician on documentation provided.
Timepoint [1] 8421 0
At discharge from the Intensive Care Unit
Secondary outcome [2] 8422 0
Number of children requiring mechanical ventilation. Type of ventilatory support will be recorded manually by the treating physician on documentation provided.
Timepoint [2] 8422 0
5 days (120 hours) from admission to Intensive Care Unit, or until discharge from ICU: whichever is sooner.
Secondary outcome [3] 8423 0
Number of children receiving any form of respiratory support (including nasal continuous positive pressure). Type of ventilatory support will be recorded manually by the treating physician on documentation provided.
Timepoint [3] 8423 0
5 days (120 hours) from admission to ICU, or until discharge from ICU: whichever is sooner.

Eligibility
Key inclusion criteria
Clinical diagnosis of bronchiolitis, defined as a first or second episode of wheezing or respiratory distress associated with an upper respiratory tract infection
Admission to a paediatric intensive care unit
Minimum age
No limit
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to aminophylline (previous severe reaction, previous atrial or ventricular arrythmia, previous seizures, previous liver dysfunction)
Episode of apnoea requiring treatment with aminophylline
Previous admission to the study
Pertussis isolated on nasopharyngeal aspirate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/10/2008
Actual
5/10/2002
Date of last participant enrolment
Anticipated
Actual
14/09/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
274
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1310 0
New Zealand
State/province [1] 1310 0

Funding & Sponsors
Funding source category [1] 4087 0
Charities/Societies/Foundations
Name [1] 4087 0
Australian and New Zealand Intensive Care Society (ANZICS) Foundation.
Country [1] 4087 0
Australia
Primary sponsor type
Hospital
Name
Prof Frank Shann
Address
Royal Childrens' Hospital,
50, Flemington Road
Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 3680 0
None
Name [1] 3680 0
Address [1] 3680 0
Country [1] 3680 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6158 0
Royal Children's Hospital, Melbourne
Ethics committee address [1] 6158 0
50, Flemington Road, Parkville
Victoria 3052
Ethics committee country [1] 6158 0
Australia
Date submitted for ethics approval [1] 6158 0
Approval date [1] 6158 0
01/09/2008
Ethics approval number [1] 6158 0

Summary
Brief summary
Bronchiolitis is a common, acute, viral infection of the lower respiratory tract. It is mostly seen in children less than 1 year of age, but does affect children up to 2 years of age. Each year, several children with severe bronchiolitis need admission to the intensive care unit. These children experience significant breathing difficulty and around 50% are ill enough to need help with breathing through a breathing machine called a mechanical ventilator. The normal treatment for these children is to support their breathing, and to give them adequate nutrition and fluids. Aminophylline is a medicine we know from previous research that improves the function of the diaphragm, the major breathing muscle. Aminophylline also stimulates the respiratory centre in the brain, which stimulates the body to breathe. This tells us that aminophylline might be a helpful drug to use when treating children with severe bronchiolitis. Some doctors use this medicine because they believe it works. Others do not use this medicine because they do not believe it works.
The purpose of this research project is to see whether aminophylline makes a difference in the treatment of children with bronchiolitis. We will compare a group of children who receive the standard treatment for bronchiolitis with a group of children who receive the standard treatment and aminophylline. We will compare the duration of mechanical ventilation and the length of intensive care and hospital stay in both groups.
Trial website
Trial related presentations / publications
Trial published as Turner A, Shann F, Delzoppo C, Henning R, Slater A, Beca J, Erickson S, Butt W. A multicentre, randomised, double-blind, placebo-controlled trial of aminophylline for bronchiolitis in infants admitted to intensive care. Critical Care and Resuscitation 2014 Sep; 16(3): 220-224.
Public notes

Contacts
Principal investigator
Name 29078 0
Prof Frank Shann
Address 29078 0
Intensive Care Unit, Royal Children's Hospital, Parkville, Victoria 3052, Australia
Country 29078 0
Australia
Phone 29078 0
61 3 93291079
Fax 29078 0
Email 29078 0
[email protected]
Contact person for public queries
Name 12235 0
Prof Prof Frank Shann
Address 12235 0
Royal Childrens' Hospital,
50, Flemington Road
Parkville Victoria 3052
Country 12235 0
Australia
Phone 12235 0
+61 3 93455220
Fax 12235 0
Email 12235 0
[email protected]
Contact person for scientific queries
Name 3163 0
Prof Prof Frank Shann
Address 3163 0
Royal Childrens' Hospital,
50, Flemington Road
Parkville Victoria 3052
Country 3163 0
Australia
Phone 3163 0
+61 3 93455220
Fax 3163 0
Email 3163 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.