High Frequency Oscillation VentilationOPEN4HFOVNCT04289324
Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Preterm Infants
A study testing regular lung recruitment in people with High Frequency Oscillation Ventilation and Extreme Prematurity, run by Medical University of Vienna at 1 site in Austria.
Trial summary
To assess whether stepwise oxygenation-guided lung recruitment at regular intervals reduces the oxygen saturation index (OSI = Mean Airway Pressure × Fraction of inspired Oxygen × 100 / peripheral Oxygen Saturation, OSI = MAPxFiO2x100/SpO2) averaged over high frequency oscillation ventilation (HFOV) time in extremely… Read more about this study
- Who is it for?
- Ages Up to 8 weeks
- Conditions the study is for
- High Frequency Oscillation Ventilation, Extreme Prematurity, Lung Injury, Acute
- What is being tested?
- regular lung recruitment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- 25 Feb 2020to 31 Aug 2025
- 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 Up to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- born below 28 weeks of gestational age
- not older than 29 weeks of postmenstrual age
- receive HFOV
Who cannot join
- known congenital anomalies of the heart, of the lung, and/or of the central nervous system
- known chromosomal abnormalities
- participation in other intervention trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Extremely Preterm Infants - A Single Center Randomized Controlled Trial
To assess whether stepwise oxygenation-guided lung recruitment at regular intervals reduces the oxygen saturation index (OSI = Mean Airway Pressure × Fraction of inspired Oxygen × 100 / peripheral Oxygen Saturation, OSI = MAPxFiO2x100/SpO2) averaged over high frequency oscillation ventilation (HFOV) time in extremely preterm infants.
Read the detailed description
Background: Open lung maneuvers aim to recruit and stabilize the majority of collapsed alveoli, using oxygenation as an indirect variable for lung volume. The stepwise oxygenation-guided lung recruitment procedure during frequency oscillatory ventilation (HFOV) in preterm infants has a low risk of lung hyperinflation and air leak syndrome. Nevertheless, open lung maneuvers at regular intervals during HFOV to maintain or restore oxygenation is not implemented as a routine procedure in the neonatal intensive care.
Aim of the study: To assess whether stepwise oxygenation-guided lung recruitment at regular intervals reduces the oxygen saturation index (OSI = Mean Airway Pressure × Fraction of inspired Oxygen × 100 / peripheral Oxygen Saturation, OSI = MAPxFiO2x100/SpO2) averaged over HFOV time in extremely preterm infants.
Study design: Single center randomized controlled study.
Methods: Thirty-six extremely preterm infants below 28 weeks of gestational age and on high frequency oscillation ventilation receive either stepwise oxygenation-guided lung recruitment maneuver at regular intervals (intervention) and upon decision of the care giving team (intervention group) or lung recruitment maneuver only upon decision of the care giving team (standard, control group). The primary outcome is the oxygen saturation index averaged over HFO ventilation time. The observation time of the HFOV will be limited to at most seven days.
Sample size: Fifteen infants need to be enrolled in each group to have 80% power (at a two-sided alpha level of 5%) to detect a difference of 25% in the oxygen saturation index between the intervention group and the control group.
Main outcome variables: Oxygen saturation index averaged over HFO ventilation time.
Secondary outcome variables: Bronchopulmonary dysplasia (BPD); days of ventilation; oxygen saturation index averaged over ventilation time (HFO and conventional ventilation); the following variables measured before, during and after a single stepwise oxygenation-guided recruitment maneuver: echocardiographic parameters, reactance, relative impedance changes, lung ultrasound measurements, transcutaneous partial carbon dioxide (CO2), blood pressure, heart rate.
- Being tested
- regular lung recruitment
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular lung recruitmentProcedure or surgery
stepwise oxygenation-guided lung recruitment at regular (twelve hours) intervals during high frequency oscillation ventilation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | lung recruitment maneuvers performed every twelve hours during HFOV Receives: Procedure: regular lung recruitment |
| Control | No intervention | no regular lung recruitment maneuvers during HFOV |
What is being measured
The primary outcome is the main question the study is designed to answer.
HFOV oxygen saturation index
oxygen saturation index averaged over high frequency oscillation ventilation for not more than seven consecutive days
Measured: through study completion, an average 10 weeks
Secondary outcomes (3)
bronchopulmonary dysplasia
respiratory support at 36 weeks postmenstrual age
Measured: through study completion, an average 10 weeks
days of ventilation
days on conventional and high frequency oscillation ventilation
Measured: through study completion, an average 10 weeks
overall oxygen saturation index
oxygen saturation index averaged over ventilation time
Measured: through study completion, an average 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start25 Feb 2020
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for High Frequency Oscillation VentilationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Parallel groups
- Model description
- Single center randomized controlled study
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Werther, Medical University of Vienna
- Investigators
- Tobias Werther, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289324
- Sponsor's protocol ID
- 1161/2019
- Acronym
- OPEN4HFOV
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2020
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rimensberger PC, Pache JC, McKerlie C, Frndova H, Cox PN. Lung recruitment and lung volume maintenance: a strategy for improving oxygenation and preventing lung injury during both conventional mechanical ventilation and high-frequency oscillation. Intensive Care Med. 2000 Jun;26(6):745-55. doi: 10.1007/s001340051242.
PubMed 10945393Rimensberger PC, Beghetti M, Hanquinet S, Berner M. First intention high-frequency oscillation with early lung volume optimization improves pulmonary outcome in very low birth weight infants with respiratory distress syndrome. Pediatrics. 2000 Jun;105(6):1202-8. doi: 10.1542/peds.105.6.1202.
PubMed 10835058De Jaegere A, van Veenendaal MB, Michiels A, van Kaam AH. Lung recruitment using oxygenation during open lung high-frequency ventilation in preterm infants. Am J Respir Crit Care Med. 2006 Sep 15;174(6):639-45. doi: 10.1164/rccm.200603-351OC. Epub 2006 Jun 8.
PubMed 16763218de Waal K, Evans N, van der Lee J, van Kaam A. Effect of lung recruitment on pulmonary, systemic, and ductal blood flow in preterm infants. J Pediatr. 2009 May;154(5):651-5. doi: 10.1016/j.jpeds.2009.01.012.
PubMed 19364558Zannin E, Doni D, Ventura ML, Fedeli T, Rigotti C, Dellaca RL, Tagliabue PE. Relationship between Mean Airways Pressure, Lung Mechanics, and Right Ventricular Output during High-Frequency Oscillatory Ventilation in Infants. J Pediatr. 2017 Jan;180:110-115. doi: 10.1016/j.jpeds.2016.09.015. Epub 2016 Oct 10.
PubMed 27745747Werther T, Kueng E, Aichhorn L, Pummer L, Goeral K, Berger A, Hermon M, Klebermass-Schrehof K. Regular lung recruitment maneuvers during high-frequency oscillatory ventilation in extremely preterm infants: a randomized controlled trial. BMC Pediatr. 2022 Dec 12;22(1):710. doi: 10.1186/s12887-022-03780-7.
PubMed 36503480
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Extremely Preterm Infants - A Single Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04289324
- Acronym / sponsor ID
- OPEN4HFOV / 1161/2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 28 Feb 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.
To assess whether stepwise oxygenation-guided lung recruitment at regular intervals reduces the oxygen saturation index (OSI = Mean Airway Pressure × Fraction of inspired Oxygen × 100 / peripheral Oxygen Saturation, OSI = MAPxFiO2x100/SpO2) averaged over high frequency oscillation ventilation (HFOV) time in extremely preterm infants.
Detailed description
Background: Open lung maneuvers aim to recruit and stabilize the majority of collapsed alveoli, using oxygenation as an indirect variable for lung volume. The stepwise oxygenation-guided lung recruitment procedure during frequency oscillatory ventilation (HFOV) in preterm infants has a low risk of lung hyperinflation and air leak syndrome. Nevertheless, open lung maneuvers at regular intervals during HFOV to maintain or restore oxygenation is not implemented as a routine procedure in the neonatal intensive care.
Aim of the study: To assess whether stepwise oxygenation-guided lung recruitment at regular intervals reduces the oxygen saturation index (OSI = Mean Airway Pressure × Fraction of inspired Oxygen × 100 / peripheral Oxygen Saturation, OSI = MAPxFiO2x100/SpO2) averaged over HFOV time in extremely preterm infants.
Study design: Single center randomized controlled study.
Methods: Thirty-six extremely preterm infants below 28 weeks of gestational age and on high frequency oscillation ventilation receive either stepwise oxygenation-guided lung recruitment maneuver at regular intervals (intervention) and upon decision of the care giving team (intervention group) or lung recruitment maneuver only upon decision of the care giving team (standard, control group). The primary outcome is the oxygen saturation index averaged over HFO ventilation time. The observation time of the HFOV will be limited to at most seven days.
Sample size: Fifteen infants need to be enrolled in each group to have 80% power (at a two-sided alpha level of 5%) to detect a difference of 25% in the oxygen saturation index between the intervention group and the control group.
Main outcome variables: Oxygen saturation index averaged over HFO ventilation time.
Secondary outcome variables: Bronchopulmonary dysplasia (BPD); days of ventilation; oxygen saturation index averaged over ventilation time (HFO and conventional ventilation); the following variables measured before, during and after a single stepwise oxygenation-guided recruitment maneuver: echocardiographic parameters, reactance, relative impedance changes, lung ultrasound measurements, transcutaneous partial carbon dioxide (CO2), blood pressure, heart rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: regular lung recruitmentlung recruitment maneuvers performed every twelve hours during HFOV |
| Control | No intervention | –no regular lung recruitment maneuvers during HFOV |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- born below 28 weeks of gestational age
- not older than 29 weeks of postmenstrual age
- receive HFOV
Key exclusion criteria (3 listed)
- known congenital anomalies of the heart, of the lung, and/or of the central nervous system
- known chromosomal abnormalities
- participation in other intervention trials
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 |
|---|---|---|
| regular lung recruitmentstepwise oxygenation-guided lung recruitment at regular (twelve hours) intervals during high frequency oscillation ventilation | Procedure or surgery | Intervention |
Primary outcome
HFOV oxygen saturation index
Time frame: through study completion, an average 10 weeks
oxygen saturation index averaged over high frequency oscillation ventilation for not more than seven consecutive days
3 secondary outcomes
bronchopulmonary dysplasia
Time frame: through study completion, an average 10 weeks
days of ventilation
Time frame: through study completion, an average 10 weeks
overall oxygen saturation index
Time frame: through study completion, an average 10 weeks
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 6 Aug 2026.
- Results publication: PubMed 10945393Rimensberger PC, Pache JC, McKerlie C, Frndova H, Cox PN. Lung recruitment and lung volume maintenance: a strategy for improving oxygenation and preventing lung injury during both conventional mechanical ventilation and high-frequency oscillation. Intensive Care Med. 2000 Jun;26(6):745-55. doi: 10.1007/s001340051242.
- Results publication: PubMed 10835058Rimensberger PC, Beghetti M, Hanquinet S, Berner M. First intention high-frequency oscillation with early lung volume optimization improves pulmonary outcome in very low birth weight infants with respiratory distress syndrome. Pediatrics. 2000 Jun;105(6):1202-8. doi: 10.1542/peds.105.6.1202.
- Results publication: PubMed 16763218De Jaegere A, van Veenendaal MB, Michiels A, van Kaam AH. Lung recruitment using oxygenation during open lung high-frequency ventilation in preterm infants. Am J Respir Crit Care Med. 2006 Sep 15;174(6):639-45. doi: 10.1164/rccm.200603-351OC. Epub 2006 Jun 8.
- Results publication: PubMed 19364558de Waal K, Evans N, van der Lee J, van Kaam A. Effect of lung recruitment on pulmonary, systemic, and ductal blood flow in preterm infants. J Pediatr. 2009 May;154(5):651-5. doi: 10.1016/j.jpeds.2009.01.012.
- Results publication: PubMed 27745747Zannin E, Doni D, Ventura ML, Fedeli T, Rigotti C, Dellaca RL, Tagliabue PE. Relationship between Mean Airways Pressure, Lung Mechanics, and Right Ventricular Output during High-Frequency Oscillatory Ventilation in Infants. J Pediatr. 2017 Jan;180:110-115. doi: 10.1016/j.jpeds.2016.09.015. Epub 2016 Oct 10.
- Derived from this study: PubMed 36503480Werther T, Kueng E, Aichhorn L, Pummer L, Goeral K, Berger A, Hermon M, Klebermass-Schrehof K. Regular lung recruitment maneuvers during high-frequency oscillatory ventilation in extremely preterm infants: a randomized controlled trial. BMC Pediatr. 2022 Dec 12;22(1):710. doi: 10.1186/s12887-022-03780-7.
- 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.
Tobias Werther principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regular lung recruitment in people with High Frequency Oscillation Ventilation and Extreme Prematurity, run by Medical University of Vienna at 1 site in Austria.
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 3 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 6 Aug 2026. 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 Austria. 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?
HFOV oxygen saturation index (time frame: through study completion, an average 10 weeks). 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 NCT04289324, which also lists 6 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 6 Aug 2026.