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

Not Applicable

Completed

• Conditions: Respiratory Syncytial Virus Bronchiolitis
• Interventions: Device: Optiflow Junior; Device: Continous Positive Airway Pressure

• Registration Number: NCT02618213
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-11-26
• Study Start: 2015-12-01
• Study First Posted: 2015-12-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Flow Oxygenation Therapy	Optiflow Junior	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
Continous Positive Airway Pressure	Continous Positive Airway Pressure	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.

Primary Outcome Measures

Name	Time	Method
respiration rate	after 6 12 18 24 and 48 hour of intervention	change in respiration rate ( RR) from preintervention value
Modified asthma score (MWAS)	Once daily as long as intervention precedes ( 1-14 days)	Change in MWAS from pre intervention value
PCo2	after 6 12 24 and 48 hours of intervention	Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value

Secondary Outcome Measures

Name	Time	Method
treatment length	from beginning of intervention to discontinuation (1-14 days)	duration of need of intervention ( hours)
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.
patient acceptance of intervention	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
Hspitalization	from hospitalization to release (1-21 days)	duration of hospitalisation ( days)

Trial Locations

Locations (2)

Hospital Lillebaelt; 🇩🇰 Kolding, Denmark

Signe Vahlkvist; 🇩🇰 Kolding, Denmark