Bronchiolitis MedDRA version: 8.1 Level: LLT Classification code 10006448 Term: Bronchiolitis
Conditions
Interventions
Trade Name: Heliox21
Product Name: Heliox21
Product Code: Heliox21
Pharmaceutical Form: Inhalation gas
Trade Name: Medical Air
Sponsors
Imperial College London
BOC Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to determine the efficacy of helium-oxygen mixtures in the management of bronchiolitis.; Secondary Objective: The secondary objectives of the trial are to determine if helium-oxygen gas mixtures: 1. Reduce the total duration of treatment needed. 2. Reduced respiratory distress as determined by the Modified Wood's Clinical Asthma Score. 3. Reduce the number of cases needing CPAP 4. Improves efficacy of CPAP when used as the driving gas 5. Reduce the need for intubation and mechanical ventilatory support. ; Primary end point(s): The study will be undertaken in two parts, each with a different primary end-point: Part A of the Study: End-point = Total duration of treatment required. To determine whether the use of heliox reduces the duration of treatment (and hence length of hospitalisation) needed to treat bronchiolitis. Part B of the Study: End-point = Proportion of cases requiring intubation. To determine whether the use of heliox reduces the number of CPAP failures, thereby reducing the need for intubation & mechanical ventilation. | — |
Countries
United Kingdom
Outcome results
None listed