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Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Home oxygen therapy
Sponsored by
Princess Margaret Hospital for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bronchiolitis focused on measuring bronchiolitis, oxygen, children

Eligibility Criteria

3 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Margaret Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Children discharged home with oxygen

Children remain in hospital for oxygen therapy

Outcomes

Primary Outcome Measures

Readmission to hospital

Secondary Outcome Measures

Number of days in hospital
parent satisfaction

Full Information

First Posted
May 8, 2008
Last Updated
May 12, 2008
Sponsor
Princess Margaret Hospital for Children
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1. Study Identification

Unique Protocol Identification Number
NCT00677066
Brief Title
Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis
Official Title
A Randomised Controlled Trial: Home Oxygen Therapy Versus Hospital Oxygen Therapy for Children With Acute Bronchiolitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Princess Margaret Hospital for Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
bronchiolitis, oxygen, children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Children discharged home with oxygen
Arm Title
2
Arm Type
No Intervention
Arm Description
Children remain in hospital for oxygen therapy
Intervention Type
Procedure
Intervention Name(s)
Home oxygen therapy
Other Intervention Name(s)
Home oxygen, Hospital oxygen
Intervention Description
Administer oxygen at home or in hospital
Primary Outcome Measure Information:
Title
Readmission to hospital
Time Frame
Within 7 days of discharge
Secondary Outcome Measure Information:
Title
Number of days in hospital
Time Frame
days
Title
parent satisfaction
Time Frame
discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew C Martin, FRACP
Organizational Affiliation
Princess Margaret Hospital for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia

12. IPD Sharing Statement

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Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis

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