About this trial
Current evidence suggests that noninvasive positive pressure ventilation (NIPPV) is more effective than continuous positive airway pressure (CPAP) in preventing respiratory failure in preterm infants with respiratory distress syndrome (RDS), both as initial and post-extubation support. NIPPV may be delivered in synchronized (sNIPPV) or non-synchronized (nsNIPPV) modes, with sNIPPV offering clear benefits by coordinating support with the infant's own breathing. Recent studies indicate sNIPPV is superior to nsNIPPV in preventing respiratory failure, though the intrapulmonary mechanisms behind this advantage remain unclear. To address this, the present study uses Electrical Impedance Tomography (EIT) to evaluate how lung volume changes during different types of breaths and ventilator inflations - spontaneous breaths, synchronized inflations, non-synchronized inflations, and backup inflations - in preterm infants receiving sNIPPV.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent by one or both parents or legal guardians
Gestational age at birth < 30 0/7 weeks
Infants on sNIPPV respiratory support
Below 4 weeks chronological age
Disqualifiers
Severe congenital malformation adversely affecting lung aeration or perfusion (e.g., congenital heart defects)
Too ill/unstable in the opinion of the treating physician.
Trial population
This study will take place at the Department of Neonatology of the University Hospital Zurich. Preterm infants on a synchronized mode of non-invasive positive pressure ventilation will be screened for eligibility and parents will be approached by the treating physician or a clinician-researcher who is authorized to access the patient's clinical data.
Trial design
Cohort
Prospective
Treatments tested in this trial
Electrical Impedance Tomography (EIT)
DeviceElectrical Impedance Tomography and clinical data will be recorded continuously. Corresponding data will be extracted and analyzed at five pre-defined timepoints.
Treatment groups
Trial outcomes
Primary outcomes
Tidal volume (VT)
Difference in relative VT (rel. ΔZ) between spontaneous breaths and synchronized inflations.
Secondary outcomes
Global lung impedance
Difference between end-expiratory lung impedance (EELI) and inspiratory onset lung impedance (SILI) during spontaneous breaths, synchronized inflations, non-synchronized inflations, and back-up inflations.
Regional tidal volume distribution
Difference in regional tidal distribution between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Center of ventilation
Difference in center of ventilation between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Silent spaces
Difference in silent spaces between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Sponsors and contacts
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University of Zurich
Lead sponsor
University Hospital, Zürich
Collaborator