Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Parviz Habibi
ORCID ID
Contact details
Department of Paediatrics
Room 250
Wright Fleming Institute
St Mary's Campus
Imperial College London
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)20 7594 3990
p.habibi@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HP002A
Study information
Scientific title
Acronym
BREATHE
Study hypothesis
Helium-oxygen gas mixtures reduce the total duration of treatment needed in the management of bronchiolitis
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bronchiolitis
Intervention
1. Heliox-21 +/- additional oxygen
2. Medical air +/- additional oxygen
Intervention type
Drug
Phase
Not Specified
Drug names
Helium-oxygen gas
Primary outcome measures
Total length of treatment needed
Secondary outcome measures
1. Proportion of cases needing continuous positive airway pressure (nCPAP)
2. Duration of nCPAP needed
3. Changes in clinical assessment parameters and measurements
Overall trial start date
03/10/2005
Overall trial end date
31/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Chronological age = 1 year or less
2. Bronchiolitis likely as a diagnosis
3. Requiring admission for treatment of respiratory distress or hypoxia (i.e. SpO2 <93%)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
298
Participant exclusion criteria
1. Any condition requiring immediate intubation (including apnoea or bradycardia)
2. Unable to maintain SpO2 >92% despite 15 l/min oxygen
3. Legal incapacity of parent/guardian to give consent
4. Participating in another drug trial in the past 4 weeks
5. Inappropriate for child to enter study, in clinician's opinion
6. Child has a tracheostomy
7. Readmitted (with a diagnosis of bronchiolitis) within 24 hours of exiting from the BREATHE study
8. If any of the following drugs were given prior to entry/enrolment into the BREATHE study:
a. Salbutamol or ipratropium/atrovent (less than 1 hour prior to entry into BREATHE)
b. Adrenaline (less than 1 hour prior to entry into BREATHE)
c. Systemic steroids (less than 4 hours prior to entry into BREATHE)
Recruitment start date
03/10/2005
Recruitment end date
31/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Paediatrics
London
W2 1PG
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
Faculty of Medicine
Level 2
Faculty Building
South Kensington Campus
Imperial College of Science
Technology & Medicine
Exhibition Road
London
SW7 2AZ
United Kingdom
+44 (0)20 7594 1188
gary.roper@imperial.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
BOC Medical
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23509160
Publication citations
-
Results
Chowdhury MM, McKenzie SA, Pearson CC, Carr S, Pao C, Shah AR, Reus E, Eliahoo J, Gordon F, Bland H, Habibi P, Heliox therapy in bronchiolitis: phase III multicenter double-blind randomized controlled trial., Pediatrics, 2013, 131, 4, 661-669, doi: 10.1542/peds.2012-1317.