High Flow in Infants With Bronchiolitis
High Flow Nasal Cannula Therapy for Infants With Bronchiolitis
1 other identifier
interventional
111
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2016
CompletedFirst Posted
Study publicly available on registry
September 23, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedMay 28, 2020
May 1, 2020
3.3 years
September 17, 2016
May 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Comfort (in points 0-10)
24 hours
ability to feed (yes or no)
5 days
duration of hospitalisation in days
15 days
admission to PICU (Pediatric Intensive Care Unit) (yes or no)
5 days
Study Arms (2)
High Flow Nasal Cannula
EXPERIMENTALOxygen delivery through Heated Humidified High Flow Nasal Cannula
Low Flow Nasal Prongs
ACTIVE COMPARATOROxygen delivery through Low Flow Nasal Prongs
Interventions
Oxygen delivery through Heated Humidified High Flow Nasal Cannula
Oxygen delivery through Low Flow Nasal Prongs
Eligibility Criteria
You may qualify if:
- bronchiolitis PEWS (Pediatric Early Warning Score 0-28) \>= 6 oxygen saturation \< 92%
You may not qualify if:
- chronic lung disease hemodynamic significant heart disease syndromal disease facial abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Isala Klinieken
Zwolle, Overijssel, 8000 GK, Netherlands
Amphia
Breda, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Ikazia Hospital
Rotterdam, Netherlands
Related Publications (1)
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.
PMID: 36941030DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jolita Bekhof, MD, PhD
Isala
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2016
First Posted
September 23, 2016
Study Start
December 1, 2016
Primary Completion
March 31, 2020
Study Completion
May 1, 2020
Last Updated
May 28, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- after publication in a journal
publication in journal