Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 8
SponsorMedical University of Vienna
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
born below 28 weeks of gestational age
not older than 29 weeks of postmenstrual age
receive HFOV
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
regular lung recruitment
Procedure/Surgerystepwise oxygenation-guided lung recruitment at regular (twelve hours) intervals during high frequency oscillation ventilation
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
bronchopulmonary dysplasia
respiratory support at 36 weeks postmenstrual age
Time frame
through study completion, an average 10 weeks2
days of ventilation
days on conventional and high frequency oscillation ventilation
Time frame
through study completion, an average 10 weeks3
overall oxygen saturation index
oxygen saturation index averaged over ventilation time
Time frame
through study completion, an average 10 weeksSponsors and contacts
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Source ClinicalTrials.gov