Bronchiolitis, ViralNCT01618175
Home Oxygen Treatment of Childhood Acute Bronchiolitis
A study testing Home oxygen therapy in people with Bronchiolitis, Viral and Home Nursing, run by Soroka University Medical Center.
Trial summary
Background: acute bronchiolitis (AB) is a common reason for hospitalization of infants in all population groups, and is usually due to respiratory syncytial virus (RSV) infection. Read more about this study
- Who is it for?
- Ages 2 to 24 months
- Conditions the study is for
- Bronchiolitis, Viral, Home Nursing
- What is being tested?
- Home oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
Background: acute bronchiolitis (AB) is a common reason for hospitalization of infants in all population groups, and is usually due to respiratory syncytial virus (RSV) infection. The main cause for hospitalization is often a need for oxygen, but can also include high fever (with a suspected secondary bacterial infection) or increasing respiratory distress. In a minority of cases (some of which can be identified in advance by defining risk groups) a serious illness may develop, including risk of respiratory failure and death. Most cases will just require supplemental oxygen and suction of secretions from the nose (as listed in the recommendations of the American Academy of Pediatrics - AAP). However, this apparently "simple" treatment still requires continued hospitalization. This results in a sharp increase in bed occupancy in Israeli hospital pediatric departments in the winter months. In recent years two studies from developed countries have been published where safety has been demonstrated for home oxygen treatment for babies with AB. However, feasibility studies have not been published yet, for example for populations living in poor conditions. The General Health Services (Klalit) in Israel provides integrated hospital and community health service to the majority of the population living o in our region, thus presenting an opportunity for optimal interventions related to this disease.
Read the 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.
- Conditions
- Bronchiolitis, Viral, Home Nursing
- Being tested
- Home oxygen therapy
- Keywords
- Bronchiolitis, Viral, Home oxygen therapy, Home Nursing, Outcome and Process Assessment (Health Care), bronchiolitis severity score
- Medical subject headings
- Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home oxygen therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Home oxygen therapy | Experimental | Infants with acute bronchiolitis of low to moderate severity will be discharged home with supplemental oxygen and monitored by phone calls and home visits. Receives: Device: Home oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hospital readmission within 10 days after discharge with home oxygen
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.
Measured: Within 10 days from discharge home with O2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2013 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis, ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618175
- Sponsor's protocol ID
- SOR0013-12CTIL
- Status last verified
- May 2012
- First submitted
- 10 Jun 2012
- Last updated
- 13 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Oxygen Treatment of Childhood Acute Bronchiolitis
- ClinicalTrials.gov ID
- NCT01618175
- Acronym / sponsor ID
- SOR0013-12CTIL
- Conditions
- Bronchiolitis, Viral, Home Nursing
- Keywords
- Bronchiolitis, Viral, Home oxygen therapy, Home Nursing, Outcome and Process Assessment (Health Care), bronchiolitis severity score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: acute bronchiolitis (AB) is a common reason for hospitalization of infants in all population groups, and is usually due to respiratory syncytial virus (RSV) infection. The main cause for hospitalization is often a need for oxygen, but can also include high fever (with a suspected secondary bacterial infection) or increasing respiratory distress. In a minority of cases (some of which can be identified in advance by defining risk groups) a serious illness may develop, including risk of respiratory failure and death. Most cases will just require supplemental oxygen and suction of secretions from the nose (as listed in the recommendations of the American Academy of Pediatrics - AAP). However, this apparently "simple" treatment still requires continued hospitalization. This results in a sharp increase in bed occupancy in Israeli hospital pediatric departments in the winter months. In recent years two studies from developed countries have been published where safety has been demonstrated for home oxygen treatment for babies with AB. However, feasibility studies have not been published yet, for example for populations living in poor conditions. The General Health Services (Klalit) in Israel provides integrated hospital and community health service to the majority of the population living o in our region, thus presenting an opportunity for optimal interventions related to this disease.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home oxygen therapy | Experimental | Device: Home oxygen therapyInfants with acute bronchiolitis of low to moderate severity will be discharged home with supplemental oxygen and monitored by phone calls and home visits. |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home oxygen therapyOxygen 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. | Device | Home oxygen therapy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Home oxygen therapy in people with Bronchiolitis, Viral and Home Nursing, run by Soroka University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hospital readmission within 10 days after discharge with home oxygen (time frame: Within 10 days from discharge home with O2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.