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High Flow in Infants With Bronchiolitis

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ClinicalTrials.gov Identifier: NCT02913040
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Other: High Flow Nasal Cannula Other: Low Flow Nasal Prongs Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: High Flow Nasal Cannula Therapy for Infants With Bronchiolitis
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : May 1, 2018

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 Name: 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 Name: LFNC




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Comfort (in points 0-10) [ Time Frame: 24 hours ]
    (FLACC: Face, Legs, Activity, Cry, Consolability, min 0- max 10 points)

  2. ability to feed (yes or no) [ Time Frame: 5 days ]
    need for tubefeeding and/or intravenous fluids

  3. duration of hospitalisation in days [ Time Frame: 15 days ]
    duration of hospitalisation in days

  4. admission to PICU (Pediatric Intensive Care Unit) (yes or no) [ Time Frame: 5 days ]


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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913040


Contacts
Contact: Jolita Bekhof, MD, PhD +31-38-4245050 j.bekhof@isala.nl

Locations
Netherlands
Isala Klinieken Recruiting
Zwolle, Overijssel, Netherlands, 8000 GK
Contact: Jolita Bekhof, MD, PhD    ++31384245050    j.bekhof@isala.nl   
Principal Investigator: Jolita Bekhof, MD, PhD         
Amphia Recruiting
Breda, Netherlands
Contact: AAPH Vaessen-verberne, MD, PhD         
Deventer Ziekenhuis Recruiting
Deventer, Netherlands
Contact: Monique Gorissen, MD    +31-570-535083    d.m.w.gorissen@dz.nl   
Medisch Spectrum Twente Recruiting
Enschede, Netherlands
Contact: Boony Thio, MD, PhD    +31-53-4872310    b.thio@mst.nl   
Martini Ziekenhuis Recruiting
Groningen, Netherlands
Contact: Arvid Kamps, MD, PhD    +31-50-5246900    a.kamps@mzh.nl   
Canisius-Wilhelmina Ziekenhuis Not yet recruiting
Nijmegen, Netherlands
Contact: Marianne Brouwer, MD, PhD    +31-24-3658708    m.l.brouwer@cwz.nl   
Ikazia Hospital Recruiting
Rotterdam, Netherlands
Contact: Ingrid Heuts, MD       i.heuts@ikazia.nl   
Sponsors and Collaborators
Princess Amalia Children's Clinic
Investigators
Principal Investigator: Jolita Bekhof, MD, PhD Isala

Responsible Party: Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier: NCT02913040     History of Changes
Other Study ID Numbers: High Flow in Bronchiolitis
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication in journal
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: after publication in a journal

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections