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

Completed

• Conditions: Bronchiolitis; Respiratory

• Registration Number: ISRCTN18238432
• Lead Sponsor: Imperial College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 298

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%)

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified