Home Oxygen Treatment of Childhood Acute Bronchiolitis
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|ClinicalTrials.gov Identifier: NCT01618175|
Recruitment Status : Unknown
Verified May 2012 by Soroka University Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 13, 2012
Last Update Posted : June 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis, Viral Home Nursing||Device: Home oxygen therapy||Not Applicable|
Objective: To develop a model of community based safe handling of AB in various communities in southern Israel.
Methods: A prospective intervention study examining the safety and health expenditures in infants with AB treated first in hospital but then discharged earlier with home oxygen while monitored in the community.
Contribution to the focus areas, and the impact of results on health policy planning: 1) Reducing hospitalization days and general financial savings. 2) Ability to implement these findings to populations with variable socio-economic backgrounds. 3) Prevention of nosocomial infections related morbidity.
Innovation and uniqueness in the study: test of this hypothesis precisely in our region, where populations have different socio-economic backgrounds, will build a model that may be suitable for all levels of society.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||August 2014|
Experimental: Home oxygen therapy
Infants with acute bronchiolitis of low to moderate severity will be discharged home with supplemental oxygen and monitored by phone calls and home visits.
Device: Home oxygen therapy
Oxygen will be provided using a generator, through nasal prongs at a flow rate up to 1 L/min.
During home stay the parents will be guided on how to suspect signs of clinical deterioration. General treatment: If oxygen saturation by pulse oximeter is greater than 92%, the oxygen will be reduced by a quarter liter per minute while monitoring for 15 minutes. If oxygen saturation decreased to less than 92% of the child will remain with the best previous oxygen flow until the next visit. Once the child reaches - 0.06 l / min for 15 minutes, he will will be checked back on room air. Cessation of oxygen therapy: when the oxygen saturation remains above 92% on room air. Every day that no home visit was performed a phone call will be done and follow-up questionnaire will be filled daily, including oxygen saturation registration.
- Rate of hospital readmission within 10 days after discharge with home oxygen [ Time Frame: Within 10 days from discharge home with O2 ]Readmission to the hospital because of (1) increased oxygen requirement (> 1 L\ minute through the nose) to maintain oxygen saturation of> 92%. (2) event of apnea. 3) feeding of less than 50% of normal with clinical evidence of dehydration, (4) the parents or pediatrician wish remove the child from the study.