Home Oxygen Therapy in Bronchiolitis
O2-Rx
Home Oxygen Therapy in the Ambulatory Treatment of Bronchiolitis
1 other identifier
interventional
135
1 country
2
Brief Summary
The aim of the study was to investigate the utility and safety of home management of home oxygen therapy in acute bronchiolitis. A matched case-control study, of one hundred and thirty five infants aged less than 12 months diagnosed bronchiolitis with hypoxia attending a pediatric community clinic will be randomly assigned to receive oxygen with or without standard nebulized therapy. Nebulized treatment with either 0.1% epinephrine diluted in bromhexine, or 3% hypertonic saline. Intermittent oxygen treatment will be administered 6 times daily for 7 days. Primary outcome measures will be emergency department visits/hospitalization secondary outcome measures will be changes in Bronchiolitis Caregiver Diary Score.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2011
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2010
CompletedFirst Posted
Study publicly available on registry
October 7, 2010
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJuly 12, 2011
July 1, 2011
1.6 years
October 6, 2010
July 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Home oxygen therapy in the ambulatory treatment of bronchiolitis
Primary outcome measures of the study will be the number of emergency room visits or hospitalizations within two weeks of enrollment in the study.
1 month
Secondary Outcomes (2)
Home oxygen therapy in the ambulatory treatment of bronchiolitis
1 month
daycare(patients) and work (parents) lost because of the illness.
1 month
Study Arms (2)
hypertonic inhalation + O2
ACTIVE COMPARATORoxygen for 30 minuets after inhalation of 3% saline 4 times daily
Epinephrine & bromhexine nebulized + O2
ACTIVE COMPARATORoxygen for 30 minuets after inhalation of racemic epinephrine with bromhexine 4 times daily
Interventions
1 lt/min oxygen via nasal cannulae intermittently for 30 minuets 4 times daily for 7 days
Eligibility Criteria
You may qualify if:
- Infants, aged less than 24 months treated for acute viral bronchiolitis in a pediatric ambulatory clinic in central Israel, during the winter season (December through April) of 2011-2013. The clinical diagnosis will be based on findings of a first clinical bronchiolitis requiring oxygen for hypoxia.
You may not qualify if:
- Infants with chronic diseases, such cardiorespiratory disease, cystic fibrosis or neonatal asthma, malignancy or immunodeficiency will be excluded, as will be infants in severe distress (respiratory rate \>80breaths/min, heart rate \>200beats/min, BCD score \>13, SpO2). Infants who had recovered from chronic neonatal lung disease of prematurity will be included. In addition, we will excluded infants who had received corticosteroids or bronchodilators in any form within 14 days before presentation and infants whose parents refused to participate or were unable to complete the Bronchiolitis Caregiver Diary Score.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Gani- Hdar Clinic
Petah Tikva, Israel
Clalit health services -Gani Hadar Clinic
Tel Aviv, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 6, 2010
First Posted
October 7, 2010
Study Start
October 1, 2011
Primary Completion
May 1, 2013
Study Completion
August 1, 2014
Last Updated
July 12, 2011
Record last verified: 2011-07