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

Study Overview
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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.

Official Title
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Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants: A Randomized Crossover Trial

Conditions
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Apnea of Prematurity, Infant, Premature, Diseases

Intervention / Treatment
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* Device: Osciflow
* Device: Highflow


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osciflow<br>Crossover sequence of experimental treatment and active comparator. | Device: Osciflow<br>* 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).<br>|
| Active Comparator: Highflow<br>Crossover sequence of experimental treatment and active comparator. | Device: Highflow<br>* Standard highflow therapy without oscillations delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paired difference in the total number of desaturations and bradycardia between Osciflow and HF |  | 180-minute recording periods for each therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paired difference in respiratory rate |  | 180-minute recording periods for each therapy | 
| Paired difference in heart rate |  | 180-minute recording periods for each therapy | 
| Paired difference in fraction of inspired oxygen [FiO2] |  | 180-minute recording periods for each therapy | 
| Paired difference in peripheral oxygen saturation [SpO2] |  | 180-minute recording periods for each therapy | 
| Paired difference in the proportion of time spent with oxygen saturations < 80% |  | 180-minute recording periods for each therapy | 
| Paired difference in the proportion of time spent with heart rates < 80 bpm |  | 180-minute recording periods for each therapy | 
| Paired difference in the number of apneas requiring stimulation |  | 180-minute recording periods for each therapy | 
| Paired difference in transcutaneous CO2 measurements |  | 180-minute recording periods for each therapy | 
| Paired difference in pain assessment using 'Bernese pain scale' | Bernese Pain-Scale for Neonates (BPSN): a 9-item multidimensional pain assessment tool that includes behavioral and physiological indicators. The instrument consists of seven subjective (alertness, crying, consolation, skin color, facial expression, posture, and changes in respiratory rate) and two physiological (i.e. objective) (changes in heart rate and oxygen saturation) indicators. Each item is rated on a four point Likert scale (0, 1, 2, and 3). Higher scores indicate greater pain-related distress, and a total score of 11 or higher is considered to indicate pain. | 180-minute recording periods for each therapy | 
| Paired difference in end-expiratory lung impedance (EELI) in a subset of patients. | EELI using electrical impedance tomography (arbitrary units per kilogram). | At the end of each intervention period | 
| Paired difference in regional ventilation distribution in a subset of patients. | Regional ventilation distribution using electrical impedance tomography (arbitrary units per kilogram). | At the end of each intervention period | 
| Paired difference in Tidal volumes in a subset of patients. | Tidal volumes using electrical impedance tomography (arbitrary units per kilogram). | At the end of each intervention period | 
| Paired difference in nasal trauma score | Royal Women's Hospital Nasal Integrity and Pressure Chart. Nasal injury is defined as stage 0-skin intact; stage 1-nonblanchable erythema of intact skin; stage 2-partial thickness skin loss involving epidermis, dermis, or both; stage 3-full thickness skin loss involving damage to or necrosis of subcutaneous tissue; stage 4-full thickness skin loss with extensive destruction, tissue necrosis, or damage to supporting structures. Lowest Score: 0. Highest Score: 4. A higher score indicates more extensive nasal injury. | At the end of each intervention period | 
| Paired difference in the rate of pneumothorax |  | 180-minute recording periods for each therapy | 
| Paired difference in reaching 'failure criteria' to stop Osciflow or HF therapy: | Definition of failure criteria Respiratory rate >90/min for more than 30 minutes Respiratory rate >20/min higher than at the beginning of the study Increase in FiO2 by ≥ 0.25 from baseline for more than 30 minutes Apnea-Score of more than 20/4 hours | 180-minute recording periods for each therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive respiratory support, Non-invasive high frequency oscillatory ventilation, Highflow nasal cannula