Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation (INSPIRE)

Intrapulmonary Volume Changes During Synchronized Noninvasive Positive Pressure Ventilation In Preterm Infants

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.

Study Overview

• Status: Recruiting
• Conditions: Infant, Preterm; Respiratory Support; Synchronized Noninvasive Positive Pressure Ventilation (SNIPPV); Chronic Lung Disease of Newborn; Lung Volume; Respiratory Distress Syndrome (Neonatal)
• Intervention / Treatment: Device: Electrical Impedance Tomography (EIT)

Detailed Description

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).

1. Sixty minutes after the beginning of the EIT recording , the noninvasve ventilation mode will be switched to CPAP for 2 minutes. This 2-minute period will be the baseline period during which spontaneous breathing will be assessed.
2. The NIV mode will then be switched back to sNIPPV. Ventilator settings will be maintained at the same levels used before the start of the study, and adjustments will not be permitted.
3. Prior to the next nursing care session, a second 2-minute nCPAP period will be introduced and serve as the baseline (together with the 1st CPAP period) .
4. The EIT recording and SpO2/HR measurements will continue until the next nursing care round, at which point the EIT belt and SpO2 sensor will be removed.

• Study Type: Observational
• Enrollment (Estimated): 27

Contacts and Locations

• Study Contact: Name: Christoph M Rüegger, MD; Phone Number: +41432539810; Email: christoph.rueegger@usz.ch
• Study Contact Backup: Name: Claudia Knöpfli; Phone Number: +41442555340; Email: claudia.knoepfli@usz.ch

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • Recruiting
      • University Hospital Zurich
      • Contact: Christoph M Rüegger, MD; Phone Number: +41432539810; Email: christoph.rueegger@usz.ch
      • Contact: Claudia Knöpfli; Phone Number: +41 44 255 53 40; Email: claudia.knoepfli@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Severe congenital malformation adversely affecting lung aeration or perfusion (e.g., congenital heart defects)
• Too ill/unstable in the opinion of the treating physician.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm infants with a gestational age < 30 0/7 weeks at birth; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal volume (VT)	Difference in relative VT (rel. ΔZ) between spontaneous breaths and synchronized inflations.	At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	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	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	At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Heart rate	Changes of heart rate between five pre-defined time points.	Continuous measurement during the 180-minute recording period.
Peripheral oxygen saturation	Changes in oxygen saturation between five pre-defined time points.	Continuous measurement during the 180-minute recording period.
Oxygen supplementation	Changes in FiO2 between five pre-defined time points.	Continuous measurement during the 180-minute recording period.
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.	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.	Immediately before the first infant handling as well as following electrical impedance tomography belt removal.

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: University Hospital, Zürich
• Investigators: Study Chair: Vincenzo Cannizzaro, MD, Newborn Research, Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 19, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Lung volume; Electrical Impedance Tomography (EIT); Synchronized noninvasive positive pressure ventilation (SNIPPV); infant, preterm
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Lung Diseases; Premature Birth; Pulmonary Atelectasis
• Other Study ID Numbers: INSPIRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No