Back to resultsHigh Flow in Infants With Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
High Flow Nasal Cannula
Low Flow Nasal Prongs
Sponsored by
About this trial
This is an interventional supportive care trial for Bronchiolitis
Eligibility Criteria
Inclusion Criteria:
- bronchiolitis PEWS (Pediatric Early Warning Score 0-28) >= 6 oxygen saturation < 92%
Exclusion Criteria:
- chronic lung disease hemodynamic significant heart disease syndromal disease facial abnormalities
Sites / Locations
- Isala Klinieken
- Amphia
- Deventer Ziekenhuis
- Medisch Spectrum Twente
- Martini Ziekenhuis
- Canisius-Wilhelmina Ziekenhuis
- Ikazia Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Flow Nasal Cannula
Low Flow Nasal Prongs
Arm Description
Oxygen delivery through Heated Humidified High Flow Nasal Cannula
Oxygen delivery through Low Flow Nasal Prongs
Outcomes
Primary Outcome Measures
PEWS (Pediatric Early Warning Score) (in points 0-28)
Sustained reduction in PEWS >= 2 points within 24 hours (min 0- max 28 points)
Secondary Outcome Measures
Comfort (in points 0-10)
(FLACC: Face, Legs, Activity, Cry, Consolability, min 0- max 10 points)
ability to feed (yes or no)
need for tubefeeding and/or intravenous fluids
duration of hospitalisation in days
duration of hospitalisation in days
admission to PICU (Pediatric Intensive Care Unit) (yes or no)
Full Information
NCT ID
NCT02913040
First Posted
September 17, 2016
Last Updated
May 26, 2020
Sponsor
Princess Amalia Children's Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02913040
Brief Title
High Flow in Infants With Bronchiolitis
Official Title
High Flow Nasal Cannula Therapy for Infants With Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Princess Amalia Children's Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Flow Nasal Cannula
Arm Type
Experimental
Arm Description
Oxygen delivery through Heated Humidified High Flow Nasal Cannula
Arm Title
Low Flow Nasal Prongs
Arm Type
Active Comparator
Arm Description
Oxygen delivery through Low Flow Nasal Prongs
Intervention Type
Other
Intervention Name(s)
High Flow Nasal Cannula
Other Intervention Name(s)
HFNC
Intervention Description
Oxygen delivery through Heated Humidified High Flow Nasal Cannula
Intervention Type
Other
Intervention Name(s)
Low Flow Nasal Prongs
Other Intervention Name(s)
LFNC
Intervention Description
Oxygen delivery through Low Flow Nasal Prongs
Primary Outcome Measure Information:
Title
PEWS (Pediatric Early Warning Score) (in points 0-28)
Description
Sustained reduction in PEWS >= 2 points within 24 hours (min 0- max 28 points)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Comfort (in points 0-10)
Description
(FLACC: Face, Legs, Activity, Cry, Consolability, min 0- max 10 points)
Time Frame
24 hours
Title
ability to feed (yes or no)
Description
need for tubefeeding and/or intravenous fluids
Time Frame
5 days
Title
duration of hospitalisation in days
Description
duration of hospitalisation in days
Time Frame
15 days
Title
admission to PICU (Pediatric Intensive Care Unit) (yes or no)
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
bronchiolitis PEWS (Pediatric Early Warning Score 0-28) >= 6 oxygen saturation < 92%
Exclusion Criteria:
chronic lung disease hemodynamic significant heart disease syndromal disease facial abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jolita Bekhof, MD, PhD
Organizational Affiliation
Isala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isala Klinieken
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8000 GK
Country
Netherlands
Facility Name
Amphia
City
Breda
Country
Netherlands
Facility Name
Deventer Ziekenhuis
City
Deventer
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
Country
Netherlands
Facility Name
Ikazia Hospital
City
Rotterdam
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
publication in journal
IPD Sharing Time Frame
after publication in a journal
Learn more about this trial
High Flow in Infants With Bronchiolitis
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