An interventional study of regular lung recruitment in High Frequency Oscillation Ventilation, Extreme Prematurity and Lung Injury, Acute, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged Up to 8 Weeks. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
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.
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.
989 studies on the registry are indexed under Acute Lung Injury; 156 are open to participants now.
This study's enrollment of 36 is below the median of 54 across 561 interventional studies indexed under Acute Lung Injury.
Browse Acute Lung Injury studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Preterm infants
Exclusion Criteria:
lung recruitment maneuvers performed every twelve hours during HFOV
Procedure: regular lung recruitment
no regular lung recruitment maneuvers during HFOV
stepwise oxygenation-guided lung recruitment at regular (twelve hours) intervals during high frequency oscillation ventilation
HFOV oxygen saturation index
oxygen saturation index averaged over high frequency oscillation ventilation for not more than seven consecutive days
Time frame: through study completion, an average 10 weeks
bronchopulmonary dysplasia
respiratory support at 36 weeks postmenstrual age
Time frame: through study completion, an average 10 weeks
days of ventilation
days on conventional and high frequency oscillation ventilation
Time frame: through study completion, an average 10 weeks
overall oxygen saturation index
oxygen saturation index averaged over ventilation time
Time frame: through study completion, an average 10 weeks
Plan to share: No
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna