Bronchiolitis randomised controlled trial (RCT): Emergency Assisted Therapy with Heliox - an Evaluation

ISRCTN	ISRCTN18238432
DOI	https://doi.org/10.1186/ISRCTN18238432
Secondary identifying numbers	HP002A

Submission date: 21/09/2005
Registration date: 29/09/2005
Last edited: 22/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Parviz Habibi
Scientific

Department of Paediatrics
Room 250
Wright Fleming Institute
St Mary's Campus
Imperial College London
Norfolk Place
London
W2 1PG
United Kingdom

Phone	+44 (0)20 7594 3990
Email	p.habibi@imperial.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	BREATHE
Study objectives	Helium-oxygen gas mixtures reduce the total duration of treatment needed in the management of bronchiolitis
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Bronchiolitis
Intervention	1. Heliox-21 +/- additional oxygen 2. Medical air +/- additional oxygen
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Helium-oxygen gas
Primary outcome measure	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 study start date	03/10/2005
Completion date	31/08/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	1 Year
Sex	Both
Target number of participants	298
Key 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%)
Key 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)
Date of first enrolment	03/10/2005
Date of final enrolment	31/08/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Paediatrics

London
W2 1PG
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

Faculty of Medicine
Level 2, Faculty Building
South Kensington Campus
Imperial College of Science, Technology & Medicine
Exhibition Road
London
SW7 2AZ
England
United Kingdom

Phone	+44 (0)20 7594 1188
Email	gary.roper@imperial.ac.uk
Website	http://www.imperial.ac.uk
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Industry

BOC Medical

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2013		Yes	No