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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Bronchiolitis
• Intervention / Treatment: Device: Continous Positive Airway Pressure; Device: Optiflow Junior

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Kolding, Denmark, 6000
    • Hospital Lillebaelt
  • Kolding, Denmark, 6000
    • Signe Vahlkvist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.; Other Names: CPAP
Active Comparator: High Flow Oxygenation Therapy; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment length	duration of need of intervention ( hours)	from beginning of intervention to discontinuation (1-14 days)
Hspitalization	duration of hospitalisation ( days)	from hospitalization to release (1-21 days)
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)
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)

Collaborators and Investigators

• Sponsor: Hospital of South West Jutland
• Investigators: Principal Investigator: Signe VAhlkvist, MD PhD, Pediatric Award, Hospital of South West Denmark

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: November 26, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Children; Bronchiolitis; High Flow Oxygenation therapy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: S-20150007