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In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea.
In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal Cannula with Low Flow Nasal Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea. The study will take place on the pediatric (Non intensive care) units of 5 different hospitals in the Netherlands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Flow Nasal Cannula | Experimental | Oxygen delivery through Heated Humidified High Flow Nasal Cannula |
|
| Low Flow Nasal Prongs | Active Comparator | Oxygen delivery through Low Flow Nasal Prongs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Nasal Cannula | Other | Oxygen delivery through Heated Humidified High Flow Nasal Cannula |
|
| Measure | Description | Time Frame |
|---|---|---|
| PEWS (Pediatric Early Warning Score) (in points 0-28) | Sustained reduction in PEWS >= 2 points within 24 hours (min 0- max 28 points) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort (in points 0-10) | (FLACC: Face, Legs, Activity, Cry, Consolability, min 0- max 10 points) | 24 hours |
| ability to feed (yes or no) | need for tubefeeding and/or intravenous fluids |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jolita Bekhof, MD, PhD | Isala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala Klinieken | Zwolle | Overijssel | 8000 GK | Netherlands | ||
| Amphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36941030 | Derived | Kooiman L, Blankespoor F, Hofman R, Kamps A, Gorissen M, Vaessen-Verberne A, Heuts I, Bekhof J. High-flow oxygen therapy in moderate to severe bronchiolitis: a randomised controlled trial. Arch Dis Child. 2023 Jun;108(6):455-460. doi: 10.1136/archdischild-2022-324697. Epub 2023 Mar 20. |
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publication in journal
after publication in a journal
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| Low Flow Nasal Prongs | Other | Oxygen delivery through Low Flow Nasal Prongs |
|
|
| 5 days |
| duration of hospitalisation in days | duration of hospitalisation in days | 15 days |
| admission to PICU (Pediatric Intensive Care Unit) (yes or no) | 5 days |
| Breda |
| Netherlands |
| Deventer Ziekenhuis | Deventer | Netherlands |
| Medisch Spectrum Twente | Enschede | Netherlands |
| Martini Ziekenhuis | Groningen | Netherlands |
| Canisius-Wilhelmina Ziekenhuis | Nijmegen | Netherlands |
| Ikazia Hospital | Rotterdam | Netherlands |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |