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OpenTrials
Completed

NCT Number: NCT02618213

Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.

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.

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Key information

Conditions

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

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Lillebaelt, Kolding, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Optiflow Junior

Device

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

Other names: High Flow Oxygenation Therapy, HFOT

Continous Positive Airway Pressure

Device

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.

Other names: CPAP

Primary outcomes

  1. respiration rate

    Time frame: after 6 12 18 24 and 48 hour of intervention

    change in respiration rate ( RR) from preintervention value

  2. PCo2

    Time frame: after 6 12 24 and 48 hours of intervention

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

  3. Modified asthma score (MWAS)

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

    Change in MWAS from pre intervention value

Secondary outcomes

  1. treatment length

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

    duration of need of intervention ( hours)

  2. Hspitalization

    Time frame: from hospitalization to release (1-21 days)

    duration of hospitalisation ( days)

  3. Intervention failure.

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

    numbers of intervention failure defined as change of intervention or progression to need for intensive care/ mechanical ventilation.

  4. patient acceptance of intervention

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

    VAS score of tolerance with intervention. 0 = worst possible acceptance 5 = fully acceptance

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 1, 2015
Registry last updated
Oct 25, 2022

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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