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

Respiratory Syncytial Virus Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618213
• Other study ID #: S-20150007
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: May 1, 2018

Study information

• Verified date: October 2022
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis
• Respiratory Syncytial Virus Bronchiolitis

Intervention

Device:
• Optiflow 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
• Continous Positive Airway Pressure
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.

Locations

Country	Name	City	State
Denmark	Hospital Lillebaelt	Kolding
Denmark	Signe Vahlkvist	Kolding

Sponsors (1)

Lead Sponsor	Collaborator
Hospital of South West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiration rate	change in respiration rate ( RR) from preintervention value	after 6 12 18 24 and 48 hour of intervention
Primary	PCo2	Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value	after 6 12 24 and 48 hours of intervention
Primary	Modified asthma score (MWAS)	Change in MWAS from pre intervention value	Once daily as long as intervention precedes ( 1-14 days)
Secondary	treatment length	duration of need of intervention ( hours)	from beginning of intervention to discontinuation (1-14 days)
Secondary	Hspitalization	duration of hospitalisation ( days)	from hospitalization to release (1-21 days)
Secondary	Intervention failure.	numbers of intervention failure defined as change of intervention or progression to need for intensive care/ mechanical ventilation.	from beginning of intervention to discontinuation.(1-14 days)
Secondary	patient acceptance of intervention	VAS score of tolerance with intervention. 0 = worst possible acceptance 5 = fully acceptance	daily VAS score (0-5) from beginning of intervention to discontinuation (1-14 days)