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Bronchiolitis randomised controlled trial (RCT): Emergency Assisted Therapy with Heliox - an Evaluation
ISRCTN ISRCTN18238432
DOI 10.1186/ISRCTN18238432
ClinicalTrials.gov identifier
EudraCT number
Public title Bronchiolitis randomised controlled trial (RCT): Emergency Assisted Therapy with Heliox - an Evaluation
Scientific title
Acronym BREATHE
Serial number at source HP002A
Study hypothesis Helium-oxygen gas mixtures reduce the total duration of treatment needed in the management of bronchiolitis
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Bronchiolitis
Participants - 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%)
Participants - 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)
Anticipated start date 03/10/2005
Anticipated end date 31/08/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 298
Interventions 1. Heliox-21 +/- additional oxygen
2. Medical air +/- additional oxygen
Primary outcome measure(s) Total length of treatment needed
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
Sources of funding BOC Medical
Trial website http://www.breathe-heliox.com
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23509160
Contact name Dr  Parviz  Habibi
  Address Department of Paediatrics
Room 250
Wright Fleming Institute
St Mary's Campus
Imperial College London
Norfolk Place
  City/town London
  Zip/Postcode W2 1PG
  Country United Kingdom
  Tel +44 (0)20 7594 3990
  Fax +44 (0)20 7594 3984
  Email p.habibi@imperial.ac.uk
Sponsor Imperial College London (UK)
  Address Faculty of Medicine
Level 2, Faculty Building
South Kensington Campus
Imperial College of Science, Technology & Medicine
Exhibition Road
  City/town London
  Zip/Postcode SW7 2AZ
  Country United Kingdom
  Tel +44 (0)20 7594 1188
  Fax +44 (0)20 7594 9843
  Email gary.roper@imperial.ac.uk
  Sponsor website: http://www.imperial.ac.uk
Date applied 21/09/2005
Last edited 22/05/2013
Date ISRCTN assigned 29/09/2005
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