High Flow in Infants With Bronchiolitis

May 26, 2020 updated by: Princess Amalia Children's Clinic

High Flow Nasal Cannula Therapy for Infants With Bronchiolitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Breda, Netherlands
        • Amphia
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Groningen, Netherlands
        • Martini Ziekenhuis
      • Nijmegen, Netherlands
        • Canisius-Wilhelmina Ziekenhuis
      • Rotterdam, Netherlands
        • Ikazia Hospital
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8000 GK
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Flow Nasal Cannula
Oxygen delivery through Heated Humidified High Flow Nasal Cannula
Other: High Flow Nasal Cannula
Oxygen delivery through Heated Humidified High Flow Nasal Cannula
Other Names:
  • HFNC
Active Comparator: Low Flow Nasal Prongs
Oxygen delivery through Low Flow Nasal Prongs
Other: Low Flow Nasal Prongs
Oxygen delivery through Low Flow Nasal Prongs
Other Names:
  • LFNC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PEWS (Pediatric Early Warning Score) (in points 0-28)
Time Frame: 24 hours
Sustained reduction in PEWS >= 2 points within 24 hours (min 0- max 28 points)
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Amalia Children's Clinic

Investigators

  • Principal Investigator: Jolita Bekhof, MD, PhD, Isala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

September 17, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • High Flow in Bronchiolitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

publication in journal

IPD Sharing Time Frame

after publication in a journal

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchiolitis

Clinical Trials on High Flow Nasal Cannula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe