NCT02618213

Brief Summary

Bronchiolitis in infants and young children often requires respiraty support. In Denmark Continous Positive Airway Pressure ( CPAP) are routinely used in children with moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with bronchiolitis. Infants and young children with moderate-severe bronchiolitis and are randomized to either CPAP or HFOT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

November 25, 2015

Last Update Submit

October 24, 2022

Conditions

Respiratory Syncytial Virus Bronchiolitis

Keywords

Continuous Positive Airway PressureHigh Flow Oxygenation therapyBronchiolitisChildren

Outcome Measures

Primary Outcomes (3)

  • respiration rate

    change in respiration rate ( RR) from preintervention value

    after 6 12 18 24 and 48 hour of intervention

  • PCo2

    Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value

    after 6 12 24 and 48 hours of intervention

  • Modified asthma score (MWAS)

    Change in MWAS from pre intervention value

    Once daily as long as intervention precedes ( 1-14 days)

Secondary Outcomes (4)

  • treatment length

    from beginning of intervention to discontinuation (1-14 days)

  • Hspitalization

    from hospitalization to release (1-21 days)

  • Intervention failure.

    from beginning of intervention to discontinuation.(1-14 days)

  • patient acceptance of intervention

    daily VAS score (0-5) from beginning of intervention to discontinuation (1-14 days)

Study Arms (2)

Continous Positive Airway Pressure

ACTIVE COMPARATOR

CPAP is administered through a binasal tube fitted with a Benveniste gas jet administered with humified airflow. Start flow is 12-14 l/min and can be changed to maximum 15 or minimum 12 l/min. Oxygen can be supplied as needed to keep SpO2 (peripheral capillary Oxygen saturation) within acceptable limits.

Device: Continous Positive Airway Pressure

High Flow Oxygenation Therapy

ACTIVE COMPARATOR

HFOT is administered by optiflow Junior ( Fisher\&Paykal Healthcare® Auckland, New Zealand) Start flow 12-14 l/min. Oxygen can be supplied as needed to keep Sp02 within acceptable limits

Device: Optiflow Junior

Interventions

Optiflow JuniorDEVICE

Humified air are dispensed through the system. Airflow, FiO2 (Fraction of inspired oxygen) , SpO2 (peripheral capillary Oxygen saturation) and respiratory rate are noted each hour. Progression of condition might lead to change of system og mechanical ventilation. poor tolerance might lead to change of system

Also known as: High Flow Oxygenation Therapy, HFOT
High Flow Oxygenation Therapy
Continous Positive Airway PressureDEVICE

Humified air are dispensed throug the system. Airflow, FiO2, SpO2 and respiratory rate are noted each hour. Progression of condition might lead to change of system or mechanical ventilation. Poor tolerance might lead to change of system.

Also known as: CPAP
Continous Positive Airway Pressure

Eligibility Criteria

Age1 Day - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • infants and children with moderate respiratoric syncytial virus bronchiolitis or other viral bronchiolitis and need of respiratory support. ( clinical decision)

You may not qualify if:

  • severe bronchiolitis with P C02 \> 9, decreased consciusness and risk for early progression to intensive therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Lillebaelt

Kolding, 6000, Denmark

Location

Signe Vahlkvist

Kolding, 6000, Denmark

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Signe VAhlkvist, MD PhD

    Pediatric Award, Hospital of South West Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 1, 2015

Study Start

December 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

October 25, 2022

Record last verified: 2022-10

Locations

DK(2)