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NCT02913040 Clinical Trial

High Flow in Infants With Bronchiolitis

Bronchiolitis Clinical Trial

Official title:
High Flow Nasal Cannula Therapy for Infants With Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02913040
Other study ID # High Flow in Bronchiolitis
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2016
Est. completion date May 1, 2020

Study information
Verified date May 2020
Source Princess Amalia Children's Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 111
Est. completion date May 1, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 24 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• High Flow Nasal Cannula
Oxygen delivery through Heated Humidified High Flow Nasal Cannula
• Low Flow Nasal Prongs
Oxygen delivery through Low Flow Nasal Prongs

Locations
Country Name City State
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 Isala Klinieken Zwolle Overijssel

Sponsors (1)
Lead Sponsor Collaborator
Princess Amalia Children's Clinic

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Comfort (in points 0-10) (FLACC: Face, Legs, Activity, Cry, Consolability, min 0- max 10 points) 24 hours
Secondary ability to feed (yes or no) need for tubefeeding and/or intravenous fluids 5 days
Secondary duration of hospitalisation in days duration of hospitalisation in days 15 days
Secondary admission to PICU (Pediatric Intensive Care Unit) (yes or no) 5 days
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