Apnea of PrematurityOsciflowNCT04327466
Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants
A study testing Osciflow and Highflow in people with Apnea of Prematurity and Infant, Premature, Diseases, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 days and older
- Conditions the study is for
- Apnea of Prematurity, Infant, Premature, Diseases
- What is being tested?
- Osciflow and Highflow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 May 2020to 26 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm infants born with a gestational age of <35 weeks
- >72 hours old
- On nCPAP with PEEP 5 mbar and FiO2 <0.3
Who cannot join
- Severe congenital malformations adversely affecting life expectancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neonatology, University Hospital Zurich
Zurich, 8091
About this study
Official title: Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants: A Randomized Crossover Trial
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.
- Conditions
- Apnea of Prematurity, Infant, Premature, Diseases
- Being tested
- Osciflow, Highflow
- Keywords
- Non-invasive respiratory support, Non-invasive high frequency oscillatory ventilation, Highflow nasal cannula
- Medical subject headings
- Apnea, Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsciflowDevice
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).
HighflowDevice
Standard highflow therapy without oscillations delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).
| Study group | Role | What they receive |
|---|---|---|
| Osciflow | Experimental | Crossover sequence of experimental treatment and active comparator. Receives: Device: Osciflow |
| Highflow | Active comparator | Crossover sequence of experimental treatment and active comparator. Receives: Device: Highflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired difference in the total number of desaturations and bradycardia between Osciflow and HF
Measured: 180-minute recording periods for each therapy
Secondary outcomes (15)
Paired difference in respiratory rate
Measured: 180-minute recording periods for each therapy
Paired difference in heart rate
Measured: 180-minute recording periods for each therapy
Paired difference in fraction of inspired oxygen [FiO2]
Measured: 180-minute recording periods for each therapy
Paired difference in peripheral oxygen saturation [SpO2]
Measured: 180-minute recording periods for each therapy
Paired difference in the proportion of time spent with oxygen saturations < 80%
Measured: 180-minute recording periods for each therapy
Paired difference in the proportion of time spent with heart rates < 80 bpm
Measured: 180-minute recording periods for each therapy
Paired difference in the number of apneas requiring stimulation
Measured: 180-minute recording periods for each therapy
Paired difference in transcutaneous CO2 measurements
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: At the end of each intervention period
Paired difference in the rate of pneumothorax
Measured: 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
Measured: 180-minute recording periods for each therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start22 May 2020
- Primary completion26 Nov 2021
- Study completion26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327466
- Sponsor's protocol ID
- Osciflow
- Acronym
- Osciflow
- Status last verified
- Jul 2024
- First submitted
- 12 Mar 2020
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rub DM, Sivieri EM, Abbasi S, Eichenwald E. Effect of high-frequency oscillation on pressure delivered by high flow nasal cannula in a premature infant lung model. Pediatr Pulmonol. 2019 Nov;54(11):1860-1865. doi: 10.1002/ppul.24459. Epub 2019 Jul 24.
PubMed 31339005Sivieri EM, Eichenwald E, Bakri SM, Abbasi S. Effect of high frequency oscillatory high flow nasal cannula on carbon dioxide clearance in a premature infant lung model: A bench study. Pediatr Pulmonol. 2019 Apr;54(4):436-443. doi: 10.1002/ppul.24216. Epub 2018 Dec 14.
PubMed 30549451
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT04327466
- Acronym / sponsor ID
- Osciflow / Osciflow
- Conditions
- Apnea of Prematurity, Infant, Premature, Diseases
- Keywords
- Non-invasive respiratory support, Non-invasive high frequency oscillatory ventilation, Highflow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osciflow | Experimental | Device: OsciflowCrossover sequence of experimental treatment and active comparator. |
| Highflow | Active comparator | Device: HighflowCrossover sequence of experimental treatment and active comparator. |
Who may qualify
- Ages
- 3 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preterm infants born with a gestational age of <35 weeks
- >72 hours old
- On nCPAP with PEEP 5 mbar and FiO2 <0.3
Key exclusion criteria (1 listed)
- Severe congenital malformations adversely affecting life expectancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsciflowOsciflow 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). | Device | Osciflow |
| HighflowStandard highflow therapy without oscillations delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period). | Device | Highflow |
Primary outcome
Paired difference in the total number of desaturations and bradycardia between Osciflow and HF
Time frame: 180-minute recording periods for each therapy
15 secondary outcomes
Paired difference in respiratory rate
Time frame: 180-minute recording periods for each therapy
Paired difference in heart rate
Time frame: 180-minute recording periods for each therapy
Paired difference in fraction of inspired oxygen [FiO2]
Time frame: 180-minute recording periods for each therapy
Paired difference in peripheral oxygen saturation [SpO2]
Time frame: 180-minute recording periods for each therapy
Paired difference in the proportion of time spent with oxygen saturations < 80%
Time frame: 180-minute recording periods for each therapy
Paired difference in the proportion of time spent with heart rates < 80 bpm
Time frame: 180-minute recording periods for each therapy
Paired difference in the number of apneas requiring stimulation
Time frame: 180-minute recording periods for each therapy
Paired difference in transcutaneous CO2 measurements
Time frame: 180-minute recording periods for each therapy
Paired difference in pain assessment using 'Bernese pain scale'
Time frame: 180-minute recording periods for each therapy
Paired difference in end-expiratory lung impedance (EELI) in a subset of patients.
Time frame: At the end of each intervention period
Paired difference in regional ventilation distribution in a subset of patients.
Time frame: At the end of each intervention period
Paired difference in Tidal volumes in a subset of patients.
Time frame: At the end of each intervention period
Paired difference in nasal trauma score
Time frame: At the end of each intervention period
Paired difference in the rate of pneumothorax
Time frame: 180-minute recording periods for each therapy
Paired difference in reaching 'failure criteria' to stop Osciflow or HF therapy:
Time frame: 180-minute recording periods for each therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 31339005Rub DM, Sivieri EM, Abbasi S, Eichenwald E. Effect of high-frequency oscillation on pressure delivered by high flow nasal cannula in a premature infant lung model. Pediatr Pulmonol. 2019 Nov;54(11):1860-1865. doi: 10.1002/ppul.24459. Epub 2019 Jul 24.
- Background: PubMed 30549451Sivieri EM, Eichenwald E, Bakri SM, Abbasi S. Effect of high frequency oscillatory high flow nasal cannula on carbon dioxide clearance in a premature infant lung model: A bench study. Pediatr Pulmonol. 2019 Apr;54(4):436-443. doi: 10.1002/ppul.24216. Epub 2018 Dec 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osciflow and Highflow in people with Apnea of Prematurity and Infant, Premature, Diseases, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired difference in the total number of desaturations and bradycardia between Osciflow and HF (time frame: 180-minute recording periods for each therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327466, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.