Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants (Osciflow)

University of Zurich (UZH)

Status: Completed

Conditions: Infant, Premature, Diseases; Apnea of Prematurity

Treatments: Device: Osciflow; Device: Highflow

Study type: Interventional

Funder types: Other

Identifiers

NCT04327466

Osciflow

Details and patient eligibility

About

This study evaluates the effect of non-invasive high frequency oscillations applied via a highflow nasal cannula ('Osciflow') compared to highflow nasal cannula without oscillations (HF) on desaturations and bradycardia in premature infants. It uses a crossover design. Infants are randomized to begin the study with either Osciflow or HF. Both modes are applied for 4 hours. Infants are monitored with an oximetry sensor to measure peripheral oxygen saturation (SpO2) and pulse rate, and with a transcutaneous CO2-transducer. Further measurements include respiratory rate and 'Bernese pain scale' evaluated by nursing staff and Electrical Impedance Tomography (EIT) in a subset of patients.

Enrollment: 30 patients

Sex: All

Ages: 3+ days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants born with a gestational age of <35 weeks
• >72 hours old
• On nCPAP with PEEP 5 mbar and FiO2 <0.3

Exclusion criteria

• Severe congenital malformations adversely affecting life expectancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Osciflow

Experimental group

Description:

Crossover sequence of experimental treatment and active comparator.

Treatment:

Device: Osciflow

Highflow

Active Comparator group

Description:

Crossover sequence of experimental treatment and active comparator.

Treatment:

Device: Highflow