Home Oxygen Treatment of Childhood Acute Bronchiolitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01618175
First received: June 10, 2012
Last updated: June 12, 2012
Last verified: May 2012
  Purpose

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 Intervention
Bronchiolitis, Viral
Home Nursing
Device: Home oxygen therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Rate of hospital readmission within 10 days after discharge with home oxygen [ Time Frame: Within 10 days from discharge home with O2 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 85
Study Start Date: October 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   2 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01618175     History of Changes
Other Study ID Numbers: SOR0013-12CTIL
Study First Received: June 10, 2012
Last Updated: June 12, 2012
Health Authority: Israel: Ministry of Health

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:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 19, 2014