High Flow in Infants With Bronchiolitis

Not Applicable

Completed

• Conditions: Bronchiolitis

• Registration Number: NCT02913040
• Lead Sponsor: Princess Amalia Children's Clinic

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.

Study Timeline

• Study First Submitted: 2016-09-17
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Study Start: 2016-12-01
• Primary Completion: 2020-03-31
• Status Verified: 2020-05
• Study Completion: 2020-05-01
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PEWS (Pediatric Early Warning Score) (in points 0-28)	24 hours	Sustained reduction in PEWS \>= 2 points within 24 hours (min 0- max 28 points)

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Isala Klinieken; 🇳🇱 Zwolle, Overijssel, 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