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High Flow in Infants With Bronchiolitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by Princess Amalia Children's Clinic
Sponsor:
Information provided by (Responsible Party):
Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier:
NCT02913040
First received: September 17, 2016
Last updated: October 15, 2016
Last verified: October 2016
  Purpose
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 Intervention
Bronchiolitis
Other: High Flow Nasal Cannula
Other: Low Flow Nasal Prongs

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: High Flow Nasal Cannula Therapy for Infants With Bronchiolitis

Further study details as provided by Princess Amalia Children's Clinic:

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

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

  • duration of hospitalisation in days [ Time Frame: 15 days ]
    duration of hospitalisation in days

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

Estimated Enrollment: 118
Study Start Date: December 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02913040

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

Locations
Netherlands
Isala Klinieken Not yet recruiting
Zwolle, Overijssel, Netherlands, 8000 GK
Contact: Jolita Bekhof, MD, PhD    ++31384245050    j.bekhof@isala.nl   
Principal Investigator: Jolita Bekhof, MD, PhD         
Deventer Ziekenhuis Not yet recruiting
Deventer, Netherlands
Contact: Monique Gorissen, MD    +31-570-535083    d.m.w.gorissen@dz.nl   
Medisch Spectrum Twente Not yet recruiting
Enschede, Netherlands
Contact: Boony Thio, MD, PhD    +31-53-4872310    b.thio@mst.nl   
Martini Ziekenhuis Not yet 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   
Sponsors and Collaborators
Princess Amalia Children's Clinic
Investigators
Principal Investigator: Jolita Bekhof, MD, PhD Isala
  More Information

Responsible Party: Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier: NCT02913040     History of Changes
Other Study ID Numbers: High Flow in Bronchiolitis
Study First Received: September 17, 2016
Last Updated: October 15, 2016
Individual Participant Data  
Plan to Share IPD: Yes

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

ClinicalTrials.gov processed this record on April 27, 2017