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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-22

Study Completion Date

2021-11-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Apnea of Prematurity Infant, Premature, Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Osciflow

Crossover sequence of experimental treatment and active comparator.

Group Type EXPERIMENTAL

Osciflow

Intervention Type DEVICE

Osciflow is a non-invasive high frequency oscillatory ventilation support delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).

Highflow

Crossover sequence of experimental treatment and active comparator.

Group Type ACTIVE_COMPARATOR

Highflow

Intervention Type DEVICE

Standard highflow therapy without oscillations delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).

Interventions

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Osciflow

Osciflow is a non-invasive high frequency oscillatory ventilation support delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).

Intervention Type DEVICE

Highflow

Standard highflow therapy without oscillations delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).

Intervention Type DEVICE