Status:
COMPLETED
Suctioning of NOse Therapy in Bronchiolitis
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Children's Hospital of Eastern Ontario
Conditions:
Bronchiolitis
Eligibility:
All Genders
4-12 years
Phase:
NA
Brief Summary
Research Questions: Primary: In otherwise healthy infants 4 weeks to 12 months of age discharged home from the ED with acute bronchiolitis,1 is there a difference in the probability of "treatment fa...
Detailed Description
This is a multi-center, randomized, outcome assessor- blinded clinical trial of infants discharged home from the ED with acute bronchiolitis. Two groups will be compared: infants receiving bronchiolit...
Eligibility Criteria
Inclusion
- Diagnosis of bronchiolitis in the ED as per the AAP diagnosis definition. Bronchiolitis is defined as the first episode of viral upper respiratory infection with respiratory distress and/or tachypnea for age.
- Age 4 weeks up to and including 12 months of age. Participating infants will have to be at least 4 weeks post their expected due date of birth since infants with bronchiolitis below this age cut-off are at a much higher risk of apnea and dehydration than their older counterparts.
- Nasal congestion as per parental report and/or the treating physician
- Must have at least one of the following: home/cellular telephone or e- mail
- Informed consent
- Parent/Caregiver speaks English/French
Exclusion
- Previous diagnosis of bronchiolitis made more than 3 weeks prior to this ED visit.
- Hospitalization at the index ED visit. Although we have considered starting the experimental intervention at presentation to the ED, this was deemed counterproductive since many patients with bronchiolitis are currently routinely suctioned in the ED which would likely contaminate the control arm and impact study results.
- Use of any battery operated suctioning device prior to arrival. These families may choose to continue these electrical devices which would contaminate the study groups.
- 4- Co-morbidities which may impact outcomes such as known diagnosis of congenital heart disease, chronic respiratory disease including known lung disease due to prematurity, aspiration due to severe gastro-esophageal reflux, neuro-muscular/neurologic disease, immunodeficiency, coagulopathies, nasal/upper airway abnormalities, oral, gastrointestinal anomalies \[except for corrected pyloric stenosis\], tracheo-esophageal fistulas, gastric/gastro-jejunal tube feeding supplementation.
Key Trial Info
Start Date :
March 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2023
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT03361371
Start Date
March 6 2020
End Date
January 25 2023
Last Update
February 8 2023
Active Locations (3)
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1
McMaster Children's Hospital
Hamilton, Ontario, Canada
2
London Children's Hospital
London, Ontario, Canada
3
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada