CompletedNot Applicable

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

Switzerland30 participantsStarted 2020-05-22

Plain-language summary

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.

Who can participate

Age range

3 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Paired difference in the total number of desaturations and bradycardia between Osciflow and HF

Timeframe: 180-minute recording periods for each therapy

Trial details

NCT IDNCT04327466

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-26

View on ClinicalTrials.gov More Apnea of Prematurity trials