An observational study in Infant, Preterm, Respiratory Distress Syndrome (Neonatal) and Chronic Lung Disease of Newborn, sponsored by University of Zurich. Recruiting at 1 site in Switzerland. Open to participants aged Up to 4 Weeks. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by University of Zurich · Observational
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.
Hypothesis:
Synchronized inflations during NIPPV will increase tidal volumes (VT) and lung aeration when compared with non-synchronized inflations. Pressure peaks delivered during expiration (non-synchronized inflations), between spontaneous breaths (backup inflations), or during periods of apnea (backup inflations) will not increase relative VT.
Primary objective:
The primary objective is to assess lung volume changes between spontaneous breaths and synchronized inflations, non-synchronized inflations, and backup inflations using EIT.
Secondary objectives:
The secondary objectives are to assess regional differences in aeration and ventilation among spontaneous breaths, synchronized inflations, non-synchronized inflations, and backup inflations using EIT.
Primary endpoint:
Difference in relative Vt (rel. Delta-Z) between spontaneous breaths and synchronized inflations.
Study procedures:
Study procedures include attaching an EIT belt and a pulse oximeter sensor during the final nursing care session before the study begins. Synchronized NIPPV is provided by EVEneo ventilators, and synchronization will be achieved through an abdominal capsule (Graseby).
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 27 is below the median of 112 across 777 observational studies indexed under Premature Birth.
Browse Premature Birth studies →University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Infants on sNIPPV respiratory support and below 4 weeks chronological age
Device: Electrical Impedance Tomography (EIT)
Electrical Impedance Tomography and clinical data will be recorded continuously. Corresponding data will be extracted and analyzed at five pre-defined timepoints.
Tidal volume (VT)
Difference in relative VT (rel. ΔZ) between spontaneous breaths and synchronized inflations.
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
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.
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Regional tidal volume distribution
Difference in regional tidal distribution between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Center of ventilation
Difference in center of ventilation between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Silent spaces
Difference in silent spaces between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Global inhomogeneity index
Difference in global inhomogeneity index between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations. An inhomogeneity index of zero represents a perfectly homogeneous distribution of ventilation.
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Coefficient of variation
Difference in coefficient of variation (EIT) between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Inspiratory time
Difference in inspiratory times between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Expiratory time
Difference in expiratory times between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Lung ultrasound score
Difference in lung ultrasound score at two pre-defined timepoints. Each lung will be divided into 3 areas. For each lung area, a 0- to 3-point score will be given (total score ranging from 0-18). Higher scores represent greater severity of lung disease.
Time frame: Immediately before the first infant handling as well as following electrical impedance tomography belt removal.
Heart rate
Changes of heart rate between five pre-defined time points.
Time frame: Continuous measurement during the 180-minute recording period.
Peripheral oxygen saturation
Changes in oxygen saturation between five pre-defined time points.
Time frame: Continuous measurement during the 180-minute recording period.
Oxygen supplementation
Changes in FiO2 between five pre-defined time points.
Time frame: Continuous measurement during the 180-minute recording period.
Plan to share: No
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