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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Helium-oxygen gas
Primary outcome measure(s)	Total length of treatment needed
Key secondary outcome measure(s)	1. Proportion of cases needing continuous positive airway pressure (nCPAP) 2. Duration of nCPAP needed 3. Changes in clinical assessment parameters and measurements
Completion date	31/08/2007

Participant type(s)	Patient
Age group	Child
Upper age limit	1 Year
Sex	All
Target sample size at registration	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

Department of Paediatrics

London
W2 1PG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes