High Flow in Infants With Bronchiolitis

NCT ID: NCT02913040

Last Updated: 2020-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2020-05-01

Brief Summary

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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

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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.

Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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High Flow Nasal Cannula

Oxygen delivery through Heated Humidified High Flow Nasal Cannula

Group Type EXPERIMENTAL

High Flow Nasal Cannula

Intervention Type OTHER

Oxygen delivery through Heated Humidified High Flow Nasal Cannula

Low Flow Nasal Prongs

Oxygen delivery through Low Flow Nasal Prongs

Group Type ACTIVE_COMPARATOR

Low Flow Nasal Prongs

Intervention Type OTHER

Oxygen delivery through Low Flow Nasal Prongs

Interventions

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High Flow Nasal Cannula

Oxygen delivery through Heated Humidified High Flow Nasal Cannula

Intervention Type OTHER

Low Flow Nasal Prongs

Oxygen delivery through Low Flow Nasal Prongs

Intervention Type OTHER

Other Intervention Names

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HFNC LFNC

Eligibility Criteria

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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
Minimum Eligible Age

1 Week

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Amalia Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jolita Bekhof, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Isala

Locations

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Isala Klinieken

Zwolle, Overijssel, Netherlands

Site Status

Amphia

Breda, , Netherlands

Site Status

Deventer Ziekenhuis

Deventer, , Netherlands

Site Status

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status

Martini Ziekenhuis

Groningen, , Netherlands

Site Status

Canisius-Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Site Status

Ikazia Hospital

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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Kooiman L, Blankespoor F, Hofman R, Kamps A, Gorissen M, Vaessen-Verberne A, Heuts I, Bekhof J. High-flow oxygen therapy in moderate to severe bronchiolitis: a randomised controlled trial. Arch Dis Child. 2023 Jun;108(6):455-460. doi: 10.1136/archdischild-2022-324697. Epub 2023 Mar 20.

Reference Type DERIVED
PMID: 36941030 (View on PubMed)

Other Identifiers

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High Flow in Bronchiolitis

Identifier Type: -

Identifier Source: org_study_id

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