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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

E. Michael sarrell, MD contact

+972-544-289279

michaelsar@clalit.org.il

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

Other trials in Israel

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 groups in NCT01216553
Study groupRoleWhat they receive
hypertonic inhalation + O2Active comparatoroxygen for 30 minuets after inhalation of 3% saline 4 times daily
Receives: Other: Oxygen Therapy
Epinephrine & bromhexine nebulized + O2Active comparatoroxygen 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.

  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.

    Measured: 1 month

Secondary outcomes (2)
  1. Home oxygen therapy in the ambulatory treatment of bronchiolitis

    Secondary outcome measures the change in bronchiolitis caregiver diary (BCD) score.

    Measured: 1 month

  2. 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.

  1. First posted7 Oct 2010 (estimated)
  2. Study startOct 2011
  3. Primary completionMay 2013 (estimated)
  4. Study completionAug 2014 (estimated)

Resources

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)
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

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.

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