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11 February 2012
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| [ Print-friendly version ] |
| Bronchiolitis randomised controlled trial (RCT): Emergency Assisted Therapy with Heliox - an Evaluation |
| ISRCTN | ISRCTN18238432 |
| ClinicalTrials.gov identifier | |
| 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 | |
| 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 | |
| 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 |
| 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 |
| gary.roper@imperial.ac.uk | |
| Sponsor website: | http://www.imperial.ac.uk |
| Date applied | 21/09/2005 |
| Last edited | 10/05/2011 |
| Date ISRCTN assigned | 29/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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