Home Oxygen Therapy in Bronchiolitis (O2-Rx)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Meir Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01216553
First received: October 6, 2010
Last updated: July 10, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Bronchiolitis
Other: Oxygen Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Home Oxygen Therapy in the Ambulatory Treatment of Bronchiolitis

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Home oxygen therapy in the ambulatory treatment of bronchiolitis [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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:
  • Home oxygen therapy in the ambulatory treatment of bronchiolitis [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Secondary outcome measures the change in bronchiolitis caregiver diary (BCD) score.

  • daycare(patients) and work (parents) lost because of the illness. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Number of day that patient has missed from daycare, forcing one parent to miss work


Estimated Enrollment: 135
Study Start Date: October 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   8 Weeks to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216553

Contacts
Contact: E. Michael sarrell, MD +972-544-289279 michaelsar@clalit.org.il

Locations
Israel
Gani- Hdar Clinic Not yet recruiting
Petah Tiqwa, Israel
Contact: E. Michae sarrell, MD    +972-544-289279    michaelsar@clalit.org.il   
Principal Investigator: E. Michael Sarrell, MD         
Clalit health services -Gani Hadar Clinic Not yet recruiting
Tel Aviv, Israel
Contact: e. michael sarrell, md    +972-544-289279    michaelsar@clalit.org.il   
Principal Investigator: E. MICHAEL SARRELL, MD         
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: E. Michael Sarrell M.D, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01216553     History of Changes
Other Study ID Numbers: 134/2010
Study First Received: October 6, 2010
Last Updated: July 10, 2011
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
Bronchiolitis
Infants
Nebulized Inhalation
RSV
Oxygen

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 19, 2014