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Home Oxygen Therapy in Bronchiolitis (O2-Rx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01216553
Recruitment Status : Unknown
Verified July 2011 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 7, 2010
Last Update Posted : July 12, 2011
Information provided by:
Meir Medical Center

Brief 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 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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Other: Oxygen Therapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Home Oxygen Therapy in the Ambulatory Treatment of Bronchiolitis
Study Start Date : October 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: hypertonic inhalation + O2
oxygen for 30 minuets after inhalation of 3% saline 4 times daily
Other: Oxygen Therapy
1 lt/min oxygen via nasal cannulae intermittently for 30 minuets 4 times daily for 7 days
Other Name: O2

Active Comparator: Epinephrine & bromhexine nebulized + O2
oxygen for 30 minuets after inhalation of racemic epinephrine with bromhexine 4 times daily
Other: Oxygen Therapy
1 lt/min oxygen via nasal cannulae intermittently for 30 minuets 4 times daily for 7 days
Other Name: O2

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Home oxygen therapy in the ambulatory treatment of bronchiolitis [ Time Frame: 1 month ]
    Secondary outcome measures the change in bronchiolitis caregiver diary (BCD) score.

  2. daycare(patients) and work (parents) lost because of the illness. [ Time Frame: 1 month ]
    Number of day that patient has missed from daycare, forcing one parent to miss work

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Weeks to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01216553

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Contact: E. Michael sarrell, MD +972-544-289279

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Gani- Hdar Clinic
Petah Tiqwa, Israel
Contact: E. Michae sarrell, MD    +972-544-289279   
Principal Investigator: E. Michael Sarrell, MD         
Clalit health services -Gani Hadar Clinic
Tel Aviv, Israel
Contact: e. michael sarrell, md    +972-544-289279   
Principal Investigator: E. MICHAEL SARRELL, MD         
Sponsors and Collaborators
Meir Medical Center

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Responsible Party: E. Michael Sarrell M.D, Clalit Health Services Identifier: NCT01216553    
Other Study ID Numbers: 134/2010
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2011
Keywords provided by Meir Medical Center:
Nebulized Inhalation
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents