Home Oxygen Therapy in Bronchiolitis (O2-Rx)

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.

Study Overview

• Status: Unknown
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: Oxygen Therapy

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 Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: e. michael sarrell, md; Phone Number: +972-544-289279; Email: michaelsar@clalit.org.il

Study Locations

• Israel
  • Petah Tiqwa, Israel
    • Gani- Hdar Clinic
    • Contact: E. Michae sarrell, MD; Phone Number: +972-544-289279; Email: michaelsar@clalit.org.il
    • Principal Investigator: E. MICHAEL SARRELL, MD
  • Tel Aviv, Israel
    • Clalit health services -Gani Hadar Clinic
    • Contact: e. michael sarrell, md; Phone Number: +972-544-289279; Email: michaelsar@clalit.org.il
    • Principal Investigator: E. MICHAEL SARRELL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: O2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ANTICIPATED): May 1, 2013
• Study Completion (ANTICIPATED): August 1, 2014

Study Registration Dates

• First Submitted: October 6, 2010
• First Submitted That Met QC Criteria: October 6, 2010
• First Posted (ESTIMATE): October 7, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 10, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: RSV; Infants; Oxygen; Bronchiolitis; Nebulized Inhalation
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 134/2010