BronchiolitisPhase 3NCT00677066
Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis
A Phase 3 study testing Home oxygen therapy in people with Bronchiolitis, run by Princess Margaret Hospital for Children at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Home oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2007to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3 - 24 months of age (corrected gestation)
- Clinical diagnosis of acute bronchiolitis
- Adequate feeding (>50% normal) \& hydration
- O2 saturation >92% on <1litre/minute nasal cannula oxygen.
- Observed and clinically stable for at least 24 hours in hospital
- Pass modified "safety in air test "
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- Caregivers must be counseled about risk of smoking around a child receiving oxygen supplementation
- Caregivers must be adequately educated about home oxygen
- HiTH nurses able to visit at home at least twice daily, in addition to daily phone call
- Paediatrician agrees that child is eligible for recruitment in study
Who cannot join
- Pre-existing cardiac, pulmonary (including chronic lung disease of infancy, cystic fibrosis and congenital or acquired airway anomalies), and neuromuscular disorders
- History of apnea
- Prematurity <34 weeks gestation
Trial locations and contacts
1 site in 1 country.
Australia1 site
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
About this study
Official title: A Randomised Controlled Trial: Home Oxygen Therapy Versus Hospital Oxygen Therapy for Children With Acute Bronchiolitis
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.
Read the detailed description
Acute bronchiolitis is the most common reason for hospital admission in children aged less than 1 year in developed countries. Over the last 25 years, hospitalization rates and admission duration have increased dramatically, resulting in substantial health care costs for both institutions and individual families.
There are currently no pharmacological therapies for acute bronchiolitis that have been shown to consistently alter the natural history of this disease. Current evidence suggests that management is essentially supportive, consisting of oxygen supplementation if the child is hypoxic and nasogastric feeds or intravenous fluids if the child is dehydrated. Oxygen supplementation is the principal determinant of the length of hospital admission for children with acute bronchiolitis and the need for supplemental oxygen is generally considered to be an absolute indication for hospitalization. However, Bajaj et al demonstrated that a carefully selected population of children with acute bronchiolitis can be managed safely with home oxygen therapy.
The escalating demand and cost of health care has driven health reforms in many countries, including Australia and the United Kingdom. These reforms have included the development of services that allow patients with a range of illnesses to be managed safely in their own home rather than hospital. Such services have been well established for children with a number of chronic conditions and although managing children with acute illnesses at home is not a new strategy, this model of care is increasingly considered an alternative to traditional in-patient hospitalisation. In addition to the financial benefits of transferring care to the patients' homes for health care providers and families, children and parents report a strong preference for such models of care.
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.
- Conditions
- Bronchiolitis
- Being tested
- Home oxygen therapy
- Keywords
- bronchiolitis, oxygen, children
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home oxygen therapyProcedure or surgery
Also called Home oxygen, Hospital oxygen
Administer oxygen at home or in hospital
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Children discharged home with oxygen Receives: Procedure: Home oxygen therapy |
| 2 | No intervention | Children remain in hospital for oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission to hospital
Measured: Within 7 days of discharge
Secondary outcomes (2)
Number of days in hospital
Measured: days
parent satisfaction
Measured: discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Margaret Hospital for Children
- Sponsor type
- University, hospital or other
- Investigators
- Andrew C Martin, FRACP, Principal investigator, Princess Margaret Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677066
- Sponsor's protocol ID
- EP 1405
- Status last verified
- May 2008
- First submitted
- 8 May 2008
- Last updated
- 13 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial: Home Oxygen Therapy Versus Hospital Oxygen Therapy for Children With Acute Bronchiolitis
- ClinicalTrials.gov ID
- NCT00677066
- Acronym / sponsor ID
- EP 1405
- Conditions
- Bronchiolitis
- Keywords
- bronchiolitis, oxygen, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Princess Margaret Hospital for ChildrenUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute bronchiolitis is the most common reason for hospital admission in children aged less than 1 year in developed countries. Over the last 25 years, hospitalization rates and admission duration have increased dramatically, resulting in substantial health care costs for both institutions and individual families.
There are currently no pharmacological therapies for acute bronchiolitis that have been shown to consistently alter the natural history of this disease. Current evidence suggests that management is essentially supportive, consisting of oxygen supplementation if the child is hypoxic and nasogastric feeds or intravenous fluids if the child is dehydrated. Oxygen supplementation is the principal determinant of the length of hospital admission for children with acute bronchiolitis and the need for supplemental oxygen is generally considered to be an absolute indication for hospitalization. However, Bajaj et al demonstrated that a carefully selected population of children with acute bronchiolitis can be managed safely with home oxygen therapy.
The escalating demand and cost of health care has driven health reforms in many countries, including Australia and the United Kingdom. These reforms have included the development of services that allow patients with a range of illnesses to be managed safely in their own home rather than hospital. Such services have been well established for children with a number of chronic conditions and although managing children with acute illnesses at home is not a new strategy, this model of care is increasingly considered an alternative to traditional in-patient hospitalisation. In addition to the financial benefits of transferring care to the patients' homes for health care providers and families, children and parents report a strong preference for such models of care.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Home oxygen therapyChildren discharged home with oxygen |
| 2 | No intervention | –Children remain in hospital for oxygen therapy |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 3 - 24 months of age (corrected gestation)
- Clinical diagnosis of acute bronchiolitis
- Adequate feeding (>50% normal) \& hydration
- O2 saturation >92% on <1litre/minute nasal cannula oxygen.
- Observed and clinically stable for at least 24 hours in hospital
Key exclusion criteria (3 listed)
- Pre-existing cardiac, pulmonary (including chronic lung disease of infancy, cystic fibrosis and congenital or acquired airway anomalies), and neuromuscular disorders
- History of apnea
- Prematurity <34 weeks gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home oxygen therapyAlso: Home oxygen, Hospital oxygenAdminister oxygen at home or in hospital | Procedure or surgery | 1 |
Primary outcome
Readmission to hospital
Time frame: Within 7 days of discharge
2 secondary outcomes
Number of days in hospital
Time frame: days
parent satisfaction
Time frame: discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew C Martin, FRACP principal investigator
Princess Margaret Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Home oxygen therapy in people with Bronchiolitis, run by Princess Margaret Hospital for Children at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission to hospital (time frame: Within 7 days of discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2008.