High Flow in Infants With Bronchiolitis

High Flow Nasal Cannula Therapy for Infants With Bronchiolitis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02913040

Enrollment

111

Registered

2016-09-23

Start date

2016-12-01

Completion date

2020-05-01

Last updated

2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

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.

Interventions

OTHERHigh Flow Nasal Cannula

Oxygen delivery through Heated Humidified High Flow Nasal Cannula

OTHERLow Flow Nasal Prongs

Oxygen delivery through Low Flow Nasal Prongs

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Weeks to 24 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026