B.R.E.A.T.H.E. Bronchiolitis RCT: Emergency Assisted Therapy with Heliox - an Evaluation. A Prospective, Double-Blinded, Randomised, Controlled Clinical Trial to assess the effect of helium-oxygen gas mixtures during the management of bronchiolitis. - BREATHE

Phase 1

• Conditions: Bronchiolitis; MedDRA version: 8.1 Level: LLT Classification code 10006448 Term: Bronchiolitis

• Registration Number: EUCTR2005-003007-36-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-01
• Study Completion: 2007-08-31
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 319

Inclusion Criteria

1. Chronological age less than or equal to 1 year of age at time of presentation.

2. Bronchiolitis is likely as a diagnosis.

3. Requiring admission for either hypoxia or concerns regarding respiratory distress.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any condition requiring immediate intubation (including apnoea or bradycardia).
2. Unable to maintain SpO2 greater than or equal to 93% despite 15L/min oxygen.
3. Legal incapacity of the parents/guardian to give consent.
4. Participation in another drug trial in the past 4 weeks.
5. Inappropriate for the child to enter the study, in the 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 clinical trial of medicinal product
• Study Design: Not specified