High Flow Nasal Cannula therapy for infants with Bronchiolitis: a randomized controlled trial
Completed
- Conditions
- Bronchiolitisluchtweginfectie1004743810024970
- Registration Number
- NL-OMON42950
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 118
Inclusion Criteria
Patients < 2 years of age, hospitalised for bronchiolitis, with need for oxygensupplementation and moderate to severe dyspnoea.
Exclusion Criteria
Bronchopulmonary dysplasia
Congenital heart disease
Congenital pulmonary abnormalities
Syndromal disease (for example trisomie 21)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Decrease in dyspnoea severity, depicted by decrease in PEWS with >= 2 points<br /><br>within 24 hours. PEWS will be assessed at t=0, 1, 2 and 3 hours and thereafter<br /><br>at least every three hours during hospitalisation, or more frequent, as<br /><br>indicated.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Respiratory rate, retractions, heart rate, conscious state, oxygen saturation,<br /><br>FiO2, temperature, Comfort (FLACC), ability to feed, tube feeding, intravenous<br /><br>fluids, bloodgas analysis (in case of PEWS >= 8, or as indicated by the treating<br /><br>physician), mechanical ventilation, referral to PICU, length of hospitalization.<br /><br>By measuring these different variables we are able to compose several composite<br /><br>dyspnoea scores other than the PEWS (i.e. RDAI Respiratory Distress Assessment<br /><br>Instrument, PRAM Pediatric Respiratory Assessment Measurement). None of these<br /><br>scores is sufficiently validated, however by measuring the most frequently<br /><br>used, we will enable comparison of our data with other studies.</p><br>