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High Flow Nasal Cannula Use in Infants With Bronchiolitis

NCT ID: NCT02737280

Last Updated: 2018-12-19

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

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-09-30

Brief Summary

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Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.

Detailed Description

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Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in five pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.

The investigators will recruit 160 infants who require oxygen therapy (oxygen saturation \<92%) during hospitalization due to a viral bronchiolitis. The participants are randomized to receive oxygen therapy either with high flow or ordinary nasal cannula.The infants are closely observed by study physicians for clinical parameters. The primary end point is treatment failure (need for change of respiratory support method). Secondary endpoints are respiratory rate (RR) and oxygen saturation (%) at specific measuring points, time from randomisation to end of oxygen therapy and time from randomisation to discharge.

Conditions

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Bronchiolitis

Keywords

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infant high flow nasal cannulae oxygen therapy bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual oxygen therapy

Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min

Group Type ACTIVE_COMPARATOR

MedKit Finland - Usual oxygen therapy

Intervention Type DEVICE

Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min

High flow oxygen therapy

High flow nasal cannula oxygen therapy with Airvo (TM, Fisher \& Paykel Healthcare) device

Group Type EXPERIMENTAL

Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy

Intervention Type DEVICE

High flow nasal cannula therapy with Airvo (TM, Fisher \& Paykel Healthcare) device

Interventions

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Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy

High flow nasal cannula therapy with Airvo (TM, Fisher \& Paykel Healthcare) device

Intervention Type DEVICE

MedKit Finland - Usual oxygen therapy

Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Admission to pediatric ward due to a presumed viral bronchiolitis
* Need of oxygen therapy (oxygen saturation \< 92%)

Exclusion Criteria

* Pertussis
* Needs intubation or CPAP on admission
* Severe congenital heart defect
* Down's syndrome
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Marjo Renko

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marjo Renko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oulu

Locations

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Central Hospital Jyväskylä

Jyväskylä, , Finland

Site Status

Oulu Unversity Hospital

Oulu, , Finland

Site Status

Seinäjoki Central Hospital

Seinäjoki, , Finland

Site Status

Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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EETTMK2015

Identifier Type: -

Identifier Source: org_study_id