Home Oxygen Treatment of Childhood Acute Bronchiolitis

NCT01618175 | Unknown

• 1 other identifier: SOR0013-12CTIL
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: acute bronchiolitis (AB) is a common reason for hospitalization of infants in all population groups, and is usually due to respiratory syncytial virus (RSV) infection. The main cause for hospitalization is often a need for oxygen, but can also include high fever (with a suspected secondary bacterial infection) or increasing respiratory distress. In a minority of cases (some of which can be identified in advance by defining risk groups) a serious illness may develop, including risk of respiratory failure and death. Most cases will just require supplemental oxygen and suction of secretions from the nose (as listed in the recommendations of the American Academy of Pediatrics - AAP). However, this apparently "simple" treatment still requires continued hospitalization. This results in a sharp increase in bed occupancy in Israeli hospital pediatric departments in the winter months. In recent years two studies from developed countries have been published where safety has been demonstrated for home oxygen treatment for babies with AB. However, feasibility studies have not been published yet, for example for populations living in poor conditions. The General Health Services (Klalit) in Israel provides integrated hospital and community health service to the majority of the population living o in our region, thus presenting an opportunity for optimal interventions related to this disease.

Conditions

Bronchiolitis, Viral; Home Nursing

Keywords

Bronchiolitis, Viral; Home oxygen therapy; Home Nursing; Outcome and Process Assessment (Health Care); bronchiolitis severity score

Outcome Measures

Primary Outcomes (1)

• Rate of hospital readmission within 10 days after discharge with home oxygen

  Readmission to the hospital because of (1) increased oxygen requirement (\> 1 L\\ minute through the nose) to maintain oxygen saturation of\> 92%. (2) event of apnea. 3) feeding of less than 50% of normal with clinical evidence of dehydration, (4) the parents or pediatrician wish remove the child from the study.

  Within 10 days from discharge home with O2

Study Arms (1)

Home oxygen therapy

EXPERIMENTAL

Infants with acute bronchiolitis of low to moderate severity will be discharged home with supplemental oxygen and monitored by phone calls and home visits.

Device: Home oxygen therapy

Interventions

Home oxygen therapy DEVICE

Oxygen will be provided using a generator, through nasal prongs at a flow rate up to 1 L/min. During home stay the parents will be guided on how to suspect signs of clinical deterioration. General treatment: If oxygen saturation by pulse oximeter is greater than 92%, the oxygen will be reduced by a quarter liter per minute while monitoring for 15 minutes. If oxygen saturation decreased to less than 92% of the child will remain with the best previous oxygen flow until the next visit. Once the child reaches - 0.06 l / min for 15 minutes, he will will be checked back on room air. Cessation of oxygen therapy: when the oxygen saturation remains above 92% on room air. Every day that no home visit was performed a phone call will be done and follow-up questionnaire will be filled daily, including oxygen saturation registration.

Home oxygen therapy

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 2-24 months, but age postconception of over 44 weeks.
• Ac. bronchiolitis clinical diagnosis: acute respiratory illness including nasal congestion, coughing and wheezing or crackles simplified, Tachypnea or retractions of the chest.
• X-ray confirms a viral diagnosis of bronchiolitis
• First attack of wheezing
• O2 Saturation \< 91% room air while arrival to the ER
• The baby and his family have a way to return to the ER after discharge
• The family lives a distance of less than 30 minutes drive from the center of Emergency Medicine
• The baby lives in an environment with no smoking
• The baby's family is available by phone
• The baby's family is ready for continuous monitoring of the baby at home 11th. Disease severity index (RDSS) of \< 4 (see definitions)

You may not qualify if:

• Previous morbidity: cardiac, pulmonary, neuromuscular, nutrition (including FTT). And congenital or acquired airway problem.
• Age since conception is less than -44 weeks.
• History of apneas
• Bacterial pneumonia suggested by a localized-focal finding on X-ray
• Previous wheezing attack
• O2 Saturation \> 92% on room air
• Family has no transportation available follow-up visits
• The family lives at a distance greater than 30 minutes drive from the medical facility
• The baby was treated with steroids for this attack
• There is no continuous monitoring of the baby at home

Sponsors & Collaborators

• Soroka University Medical Center: lead

MeSH Terms

Conditions

Bronchiolitis, Viral

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Respiratory Tract Infections; Infections; Virus Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2012
• First Posted: June 13, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2014
• Last Updated: June 13, 2012

Record last verified: 2012-05