Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Controlled Trial: Home Oxygen Therapy Versus Hospital Oxygen Therapy for Children With Acute Bronchiolitis

Conditions
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Bronchiolitis

Intervention / Treatment
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* Procedure: Home oxygen therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Children discharged home with oxygen | Procedure: Home oxygen therapy<br>* Administer oxygen at home or in hospital<br>* Other names: Hospital oxygen;|
| No Intervention: 2<br>Children remain in hospital for oxygen therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission to hospital |  | Within 7 days of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days in hospital |  | days | 
| parent satisfaction |  | discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchiolitis, oxygen, children