Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis

NCT ID: NCT00677066

Last Updated: 2008-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2007-12-31

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.

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

Keywords

bronchiolitis; oxygen; children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

Children discharged home with oxygen

Group Type: EXPERIMENTAL

Home oxygen therapy

Intervention Type: PROCEDURE

Administer oxygen at home or in hospital

2

Children remain in hospital for oxygen therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home oxygen therapy

Administer oxygen at home or in hospital

Intervention Type: PROCEDURE

Other Intervention Names

Home oxygen; Hospital oxygen

Eligibility Criteria

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

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital for Children

OTHER

Sponsor Role: lead

Responsible Party

Princess Margaret Hospital for Children

Principal Investigators

Andrew C Martin, FRACP

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital for Children

Locations

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

EP 1405

Identifier Type: -

Identifier Source: org_study_id