Home Oxygen Therapy in Bronchiolitis

NCT ID: NCT01216553

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

hypertonic inhalation + O2

oxygen for 30 minuets after inhalation of 3% saline 4 times daily

Group Type: ACTIVE_COMPARATOR

Oxygen Therapy

Intervention Type: OTHER

1 lt/min oxygen via nasal cannulae intermittently for 30 minuets 4 times daily for 7 days

Epinephrine & bromhexine nebulized + O2

oxygen for 30 minuets after inhalation of racemic epinephrine with bromhexine 4 times daily

Group Type: ACTIVE_COMPARATOR

Oxygen Therapy

Intervention Type: OTHER

1 lt/min oxygen via nasal cannulae intermittently for 30 minuets 4 times daily for 7 days

Interventions

Oxygen Therapy

1 lt/min oxygen via nasal cannulae intermittently for 30 minuets 4 times daily for 7 days

Intervention Type: OTHER

Other Intervention Names

O2

Eligibility 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.

• Minimum Eligible Age: 8 Weeks
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Clalit Health Services

Locations

Gani- Hdar Clinic

Petah Tikva, , Israel

Clalit health services -Gani Hadar Clinic

Tel Aviv, , Israel

Countries

Israel

Central Contacts

E. Michael sarrell, MD

Role: CONTACT

michaelsar@clalit.org.il

+972-544-289279

Facility Contacts

E. Michae sarrell, MD

Role: primary

michaelsar@clalit.org.il

+972-544-289279

e. michael sarrell, md

Role: primary

michaelsar@clalit.org.il

+972-544-289279

Other Identifiers

134/2010

Identifier Type: -

Identifier Source: org_study_id