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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02618213
Enrollment
50
Registered
2015-12-01
Start date
2015-12-01
Completion date
2018-05-01
Last updated
2022-10-25

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

Conditions

Respiratory Syncytial Virus Bronchiolitis

Keywords

Continuous Positive Airway Pressure, High Flow Oxygenation therapy, Bronchiolitis, Children

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.

Interventions

DEVICEOptiflow Junior

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

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.

Sponsors

Esbjerg Hospital - University Hospital of Southern Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 24 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
respiration rateafter 6 12 18 24 and 48 hour of interventionchange in respiration rate ( RR) from preintervention value
PCo2after 6 12 24 and 48 hours of interventionChange in PCo2 (partial pressure of carbon dioxide)from pre intervention value
Modified asthma score (MWAS)Once daily as long as intervention precedes ( 1-14 days)Change in MWAS from pre intervention value

Secondary

MeasureTime frameDescription
treatment lengthfrom beginning of intervention to discontinuation (1-14 days)duration of need of intervention ( hours)
patient acceptance of interventiondaily 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
Hspitalizationfrom hospitalization to release (1-21 days)duration of hospitalisation ( days)
Intervention failure.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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026