- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00677066
Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis
A Randomised Controlled Trial: Home Oxygen Therapy Versus Hospital Oxygen Therapy for Children With Acute Bronchiolitis
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 "
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Children discharged home with oxygen
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Administer oxygen at home or in hospital
Other Names:
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No Intervention: 2
Children remain in hospital for oxygen therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Readmission to hospital
Time Frame: Within 7 days of discharge
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Within 7 days of discharge
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of days in hospital
Time Frame: days
|
days
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parent satisfaction
Time Frame: discharge
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discharge
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Collaborators and Investigators
Investigators
- Principal Investigator: Andrew C Martin, FRACP, Princess Margaret Hospital for Children
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EP 1405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bronchiolitis
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-
Hillel Yaffe Medical CenterCompletedReflexology | Bronchiolitis; ChemicalIsrael
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Guy's and St Thomas' NHS Foundation TrustCompletedAcute Viral BronchiolitisUnited Kingdom
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Assistance Publique - Hôpitaux de ParisCompletedAcute Viral BronchiolitisFrance
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Ministry of Health, SpainCompleted
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National Heart, Lung, and Blood Institute (NHLBI)CompletedBronchiolitis Obliterans | Graft Versus Host Disease | Graft-Versus-Host Disease | Constructive Bronchiolitis | Bronchiolitis, Exudative | Bronchiolitis, ProliferativeUnited States
-
Hospices Civils de LyonRecruiting
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Assistance Publique - Hôpitaux de ParisCompletedSevere Viral BronchiolitisFrance
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University Hospital, Basel, SwitzerlandRecruitingBronchiolitis Obliterans Syndrome (BOS) | Bronchiolitis Obliterans (BO)Switzerland, Saudi Arabia
-
Groupe Hospitalier du HavreCompletedAcute Viral BronchiolitisFrance
Clinical Trials on Home oxygen therapy
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Soroka University Medical CenterUnknownBronchiolitis, Viral | Home Nursing
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Translational Research Center for Medical Innovation...Kobe City Medical Center General HospitalCompletedChronic Obstructive Pulmonary Disease (COPD)Japan
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Translational Research Center for Medical Innovation...Kobe City Medical Center General HospitalCompletedChronic Obstructive Pulmonary Disease (COPD)Japan
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Bayside HealthMonash University; Baker Heart and Diabetes Institute; Ambulance Victoria; FALCK...UnknownCoronary Artery Disease | Acute Myocardial InfarctionAustralia
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Aalborg University HospitalUniversity of AarhusUnknownCardiac Surgery | Cardiopulmonary Bypass | Acute Lung Injury | Hyperoxia | Oxygen ToxicityDenmark
-
Cairo UniversityActive, not recruiting
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The First Affiliated Hospital of Zhejiang Chinese...Not yet recruitingCOVID-19 | Cognitive Decline | SARS CoV 2 InfectionChina
-
Monash UniversityRecruitingFibrotic Interstitial Lung DiseaseAustralia
-
Ain Shams UniversityRecruitingOxygen Therapy | Pulmonary ResectionEgypt
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UMC UtrechtThe Netherlands Cancer InstituteCompletedBreast Cancer | Radiation ToxicityNetherlands