Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00677066




Registration number
NCT00677066
Ethics application status
Date submitted
8/05/2008
Date registered
13/05/2008
Date last updated
13/05/2008

Titles & IDs
Public title
Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis
Scientific title
A Randomised Controlled Trial: Home Oxygen Therapy Versus Hospital Oxygen Therapy for Children With Acute Bronchiolitis
Secondary ID [1] 0 0
EP 1405
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Home oxygen therapy

Experimental: 1 - Children discharged home with oxygen

No Intervention: 2 - Children remain in hospital for oxygen therapy


Treatment: Surgery: Home oxygen therapy
Administer oxygen at home or in hospital
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Readmission to hospital
Timepoint [1] 0 0
Within 7 days of discharge
Secondary outcome [1] 0 0
Number of days in hospital
Timepoint [1] 0 0
days
Secondary outcome [2] 0 0
parent satisfaction
Timepoint [2] 0 0
discharge

Eligibility
Key inclusion criteria
1. 3 - 24 months of age (corrected gestation)

2. Clinical diagnosis of acute bronchiolitis

3. Adequate feeding (>50% normal) & hydration

4. O2 saturation >92% on <1litre/minute nasal cannula oxygen.

5. Observed and clinically stable for at least 24 hours in hospital

6. Pass modified "safety in air test "

7. Caregivers must be counseled about risk of smoking around a child receiving oxygen
supplementation

8. Caregivers must be adequately educated about home oxygen

9. HiTH nurses able to visit at home at least twice daily, in addition to daily phone
call

10. Paediatrician agrees that child is eligible for recruitment in study
Minimum age
3 Months
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pre-existing cardiac, pulmonary (including chronic lung disease of infancy, cystic
fibrosis and congenital or acquired airway anomalies), and neuromuscular disorders

2. History of apnea

3. Prematurity <34 weeks gestation

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Princess Margaret Hospital for Children
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Home oxygen therapy is considered an appropriate and relatively safe option for children with
chronic respiratory problems such as chronic lung disease of prematurity, but the use of home
oxygen therapy for children with acute respiratory problems is limited. With the recent
establishment of a "Hospital in The Home" (HiTH) program at our institution, we sought to
determine the safety, parental satisfaction and economic advantage of home oxygen therapy for
children with acute bronchiolitis compared with traditional inpatient hospitalization.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00677066
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew C Martin, FRACP
Address 0 0
Princess Margaret Hospital for Children
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00677066