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Home Oxygen Treatment of Childhood Acute Bronchiolitis

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: NCT01618175
Recruitment Status : Unknown
Verified May 2012 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 13, 2012
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):
Soroka University Medical Center

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis, Viral Home Nursing Device: Home oxygen therapy Not Applicable

Detailed Description:

Objective: To develop a model of community based safe handling of AB in various communities in southern Israel.

Methods: A prospective intervention study examining the safety and health expenditures in infants with AB treated first in hospital but then discharged earlier with home oxygen while monitored in the community.

Contribution to the focus areas, and the impact of results on health policy planning: 1) Reducing hospitalization days and general financial savings. 2) Ability to implement these findings to populations with variable socio-economic backgrounds. 3) Prevention of nosocomial infections related morbidity.

Innovation and uniqueness in the study: test of this hypothesis precisely in our region, where populations have different socio-economic backgrounds, will build a model that may be suitable for all levels of society.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Home oxygen therapy
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

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.

Primary Outcome Measures :
  1. Rate of hospital readmission within 10 days after discharge with home oxygen [ Time Frame: Within 10 days from discharge home with O2 ]
    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.

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Ages Eligible for Study:   2 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

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Responsible Party: Soroka University Medical Center Identifier: NCT01618175     History of Changes
Other Study ID Numbers: SOR0013-12CTIL
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: May 2012
Keywords provided by Soroka University Medical Center:
Bronchiolitis, Viral
Home oxygen therapy
Home Nursing
Outcome and Process Assessment (Health Care)
bronchiolitis severity score
Additional relevant MeSH terms:
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Bronchiolitis, Viral
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases