Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis

NCT00677066 | Completed Phase 3 DMC

• 1 other identifier: EP 1405
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

bronchiolitis; oxygen; children

Outcome Measures

Primary Outcomes (1)

• Readmission to hospital

  Within 7 days of discharge

Secondary Outcomes (2)

• Number of days in hospital

  days

• parent satisfaction

  discharge

Study Arms (2)

1

EXPERIMENTAL

Children discharged home with oxygen

Procedure: Home oxygen therapy

2

NO INTERVENTION

Children remain in hospital for oxygen therapy

Interventions

Home oxygen therapy PROCEDURE

Administer oxygen at home or in hospital

Also known as: Home oxygen, Hospital oxygen

1

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Princess Margaret Hospital for Children: lead

Study Sites (1)

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Andrew C Martin, FRACP

  Princess Margaret Hospital for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 13, 2008
• Study Start: August 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 13, 2008

Record last verified: 2008-05

Locations

AU (1)