- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01618175
Home Oxygen Treatment of Childhood Acute Bronchiolitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 2-24 months, but age postconception of over 44 weeks.
- Ac. bronchiolitis clinical diagnosis: acute respiratory illness including nasal congestion, coughing and wheezing or crackles simplified, Tachypnea or retractions of the chest.
- X-ray confirms a viral diagnosis of bronchiolitis
- First attack of wheezing
- O2 Saturation < 91% room air while arrival to the ER
- The baby and his family have a way to return to the ER after discharge
- The family lives a distance of less than 30 minutes drive from the center of Emergency Medicine
- The baby lives in an environment with no smoking
- The baby's family is available by phone
- The baby's family is ready for continuous monitoring of the baby at home 11th. Disease severity index (RDSS) of < 4 (see definitions)
Exclusion Criteria:
- Previous morbidity: cardiac, pulmonary, neuromuscular, nutrition (including FTT). And congenital or acquired airway problem.
- Age since conception is less than -44 weeks.
- History of apneas
- Bacterial pneumonia suggested by a localized-focal finding on X-ray
- Previous wheezing attack
- O2 Saturation > 92% on room air
- Family has no transportation available follow-up visits
- The family lives at a distance greater than 30 minutes drive from the medical facility
- The baby was treated with steroids for this attack
- There is no continuous monitoring of the baby at home
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Within 10 days from discharge home with O2
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOR0013-12CTIL
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