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

Modulex

Status: Completed

Conditions: Respiratory Syncytial Virus Bronchiolitis

Treatments: Device: Optiflow Junior; Device: Continous Positive Airway Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT02618213

S-20150007

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 1 day to 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Continous Positive Airway Pressure

Active Comparator group

Description:

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.

Treatment:

Device: Continous Positive Airway Pressure

High Flow Oxygenation Therapy

Active Comparator group

Description:

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

Treatment:

Device: Optiflow Junior