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NCT Number: NCT02913040

High Flow in 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.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 week–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isala Klinieken, Zwolle, Overijssel, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Flow Nasal Cannula

Other

Oxygen delivery through Heated Humidified High Flow Nasal Cannula

Other names: HFNC

Low Flow Nasal Prongs

Other

Oxygen delivery through Low Flow Nasal Prongs

Other names: LFNC

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Princess Amalia Children's Clinic

Other

Registry information

Official study title

High Flow Nasal Cannula Therapy for Infants With Bronchiolitis

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2016
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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