Home Oxygen Treatment of Childhood Acute Bronchiolitis

Bronchiolitis, Viral Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01618175
• Other study ID #: SOR0013-12CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 10, 2012
• Last updated: June 12, 2012
• Start date: October 2012
• Est. completion date: August 2014

Study information

• Verified date: May 2012
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 85
• Est. completion date: August 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 24 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral
• Home Nursing

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No