BronchiolitisPhase 4O2-RxNCT01216553
Home Oxygen Therapy in Bronchiolitis
A Phase 4 study testing Oxygen Therapy in people with Bronchiolitis, run by Meir Medical Center at 2 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 weeks to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Oxygen Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 2 sitesIsrael
- Study dates
- Oct 2011to Aug 2014
- Phase
- Phase 4
- 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 8 weeks to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Gani- Hdar Clinic
Petah Tikva
E. Michae sarrell, MD, +972-544-289279, michaelsar@clalit.org.il
E. Michael Sarrell, MD
Clalit health services -Gani Hadar Clinic
Tel Aviv
e. michael sarrell, md, +972-544-289279, michaelsar@clalit.org.il
E. MICHAEL SARRELL, MD
About this study
Official title: Home Oxygen Therapy in the Ambulatory Treatment of Bronchiolitis
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.
Read the detailed description
Bronchiolitis is an infection of the bronchiolar epithelium. It is associated with profound submucosal and adventitial edema, increased secretion of mucus, and obstructed flow in the small airways, leading to hyperinflation, atelectasis, and wheezing. Respiratory syncytial virus (RSV) is responsible for the majority of cases .Bronchiolitis is the most frequent lower respiratory tract infection with high morbidity, and the leading cause of hospitalization in young children. Studies from developed countries report an incidence hospitalization of 30 per 1000 children in the first year of life and an annual mortality rate of 1.82-2 per 100,000 live births. The cost of treatment is about $2.5 billion yearly. One group from the United States estimated the annual hospital costs for bronchiolitis at $365-$691 million.
Of children who develop bronchiolitis during the first 2 year of life, approximately 1 in 10 ( 3% of all infants in the USA) will be hospitalized furthermore, a substantial proportion of infants remain in the hospital to receive oxygen until their hypoxia has improved.
The current in hospital treatment for acute viral bronchiolitis is mainly supportive, consisting of supplemental oxygen, suction and hydration . Airway edema and sloughing of respiratory epithelia cell cause mismatching of ventilation and perfusion and subsequently reduction in oxygenation (PaO2 and Spo2). Emergency Department referral (ED) and Hospital admission (HA) admission, have increased secondary to increase sensitivity of pulse oximetry for detection of hypoxia ( compared with clinical observation. The therapeutic role of bronchodilators although of questionable clinical importance is commonly used A recent review reported has shown short-term improvement in clinical scores, but no improvement in oxygenation or rate of hospitalization. Neither systemic glucocorticoids nor antibiotics appear to have any clinically significant effect on the disease course. Antiviral agents (Ribavirin) are indicated only in children with a serious underlying disorder. Trials with chest physiotherapy using vibration and percussion techniques failed to reduce the severity of the illness, length of hospitalization, or oxygen requirements, and treatment with nebulized furosemide ,inhaled interferon alpha-2a (Roferon A) ,and rhDNase proved ineffective.
Clinicians are now influenced significantly in their decision for Emergency Department referral and hospitalization of patient with respiratory disease. We hypothesized that adding short term home intermittent oxygen therapy for 7 days to other treatment modalities will reduce hypoxias and Emergency Ward referral. The aim of the present study was to compare the outcome of this combined treatment with oxygen with other medical modalities to oxygen alone and with placebo in children with RSV bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- Oxygen Therapy
- Keywords
- Bronchiolitis, Infants, Nebulized Inhalation, RSV, Oxygen
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen TherapyOther
Also called O2
1 lt/min oxygen via nasal cannulae intermittently for 30 minuets 4 times daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| hypertonic inhalation + O2 | Active comparator | oxygen for 30 minuets after inhalation of 3% saline 4 times daily Receives: Other: Oxygen Therapy |
| Epinephrine & bromhexine nebulized + O2 | Active comparator | oxygen for 30 minuets after inhalation of racemic epinephrine with bromhexine 4 times daily Receives: Other: Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
Home oxygen therapy in the ambulatory treatment of bronchiolitis
Secondary outcome measures the change in bronchiolitis caregiver diary (BCD) score.
Measured: 1 month
daycare(patients) and work (parents) lost because of the illness.
Number of day that patient has missed from daycare, forcing one parent to miss work
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2011
- Primary completionMay 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 BronchiolitisStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216553
- Sponsor's protocol ID
- 134/2010
- Acronym
- O2-Rx
- Status last verified
- Jul 2011
- First submitted
- 6 Oct 2010
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Oxygen Therapy in the Ambulatory Treatment of Bronchiolitis
- ClinicalTrials.gov ID
- NCT01216553
- Acronym / sponsor ID
- O2-Rx / 134/2010
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, Infants, Nebulized Inhalation, RSV, Oxygen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 7 Oct 2010 (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.
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.
Detailed description
Bronchiolitis is an infection of the bronchiolar epithelium. It is associated with profound submucosal and adventitial edema, increased secretion of mucus, and obstructed flow in the small airways, leading to hyperinflation, atelectasis, and wheezing. Respiratory syncytial virus (RSV) is responsible for the majority of cases .Bronchiolitis is the most frequent lower respiratory tract infection with high morbidity, and the leading cause of hospitalization in young children. Studies from developed countries report an incidence hospitalization of 30 per 1000 children in the first year of life and an annual mortality rate of 1.82-2 per 100,000 live births. The cost of treatment is about $2.5 billion yearly. One group from the United States estimated the annual hospital costs for bronchiolitis at $365-$691 million.
Of children who develop bronchiolitis during the first 2 year of life, approximately 1 in 10 ( 3% of all infants in the USA) will be hospitalized furthermore, a substantial proportion of infants remain in the hospital to receive oxygen until their hypoxia has improved.
The current in hospital treatment for acute viral bronchiolitis is mainly supportive, consisting of supplemental oxygen, suction and hydration . Airway edema and sloughing of respiratory epithelia cell cause mismatching of ventilation and perfusion and subsequently reduction in oxygenation (PaO2 and Spo2). Emergency Department referral (ED) and Hospital admission (HA) admission, have increased secondary to increase sensitivity of pulse oximetry for detection of hypoxia ( compared with clinical observation. The therapeutic role of bronchodilators although of questionable clinical importance is commonly used A recent review reported has shown short-term improvement in clinical scores, but no improvement in oxygenation or rate of hospitalization. Neither systemic glucocorticoids nor antibiotics appear to have any clinically significant effect on the disease course. Antiviral agents (Ribavirin) are indicated only in children with a serious underlying disorder. Trials with chest physiotherapy using vibration and percussion techniques failed to reduce the severity of the illness, length of hospitalization, or oxygen requirements, and treatment with nebulized furosemide ,inhaled interferon alpha-2a (Roferon A) ,and rhDNase proved ineffective.
Clinicians are now influenced significantly in their decision for Emergency Department referral and hospitalization of patient with respiratory disease. We hypothesized that adding short term home intermittent oxygen therapy for 7 days to other treatment modalities will reduce hypoxias and Emergency Ward referral. The aim of the present study was to compare the outcome of this combined treatment with oxygen with other medical modalities to oxygen alone and with placebo in children with RSV bronchiolitis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertonic inhalation + O2 | Active comparator | Other: Oxygen Therapyoxygen for 30 minuets after inhalation of 3% saline 4 times daily |
| Epinephrine & bromhexine nebulized + O2 | Active comparator | Other: Oxygen Therapyoxygen for 30 minuets after inhalation of racemic epinephrine with bromhexine 4 times daily |
Who may qualify
- Ages
- 8 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Oxygen TherapyAlso: O21 lt/min oxygen via nasal cannulae intermittently for 30 minuets 4 times daily for 7 days | Other | Epinephrine & bromhexine nebulized + O2, hypertonic inhalation + O2 |
Primary outcome
Home oxygen therapy in the ambulatory treatment of bronchiolitis
Time frame: 1 month
Primary outcome measures of the study will be the number of emergency room visits or hospitalizations within two weeks of enrollment in the study.
2 secondary outcomes
Home oxygen therapy in the ambulatory treatment of bronchiolitis
Time frame: 1 month
daycare(patients) and work (parents) lost because of the illness.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxygen Therapy in people with Bronchiolitis, run by Meir Medical Center at 2 sites in Israel.
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 1 inclusion and 1 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 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact E. Michael sarrell, MD (+972-544-289279, michaelsar@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home oxygen therapy in the ambulatory treatment of bronchiolitis (time frame: 1 month). 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 12 Jul 2011.