High Flow in Infants With Bronchiolitis

Not Applicable

Completed

• Conditions: Bronchiolitis
• Interventions: Other: High Flow Nasal Cannula; Other: Low Flow Nasal Prongs

• 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

Arm && Interventions

Group	Intervention	Description
High Flow Nasal Cannula	High Flow Nasal Cannula	Oxygen delivery through Heated Humidified High Flow Nasal Cannula
Low Flow Nasal Prongs	Low Flow Nasal Prongs	Oxygen delivery through Low Flow Nasal Prongs

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)

Amphia; 🇳🇱 Breda, Netherlands

Martini Ziekenhuis; 🇳🇱 Groningen, Netherlands

Deventer Ziekenhuis; 🇳🇱 Deventer, Netherlands

Canisius-Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Netherlands

Ikazia Hospital; 🇳🇱 Rotterdam, Netherlands

Isala Klinieken; 🇳🇱 Zwolle, Overijssel, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands