Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation

NCT07237139 | Recruiting

• 1 other identifier: INSPIRE
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Lung Disease of Newborn; Synchronized Noninvasive Positive Pressure Ventilation (SNIPPV); Lung Volume; Infant, Preterm; Respiratory Distress Syndrome (Neonatal); Respiratory Support

Keywords

Synchronized noninvasive positive pressure ventilation (SNIPPV); Lung volume; Electrical Impedance Tomography (EIT); infant, preterm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Global lung impedance

  At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.

• Regional tidal volume distribution

  At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.

• Center of ventilation

  At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.

• Silent spaces

  At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.

• Global inhomogeneity index

  At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.

Study Arms (1)

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)

Interventions

Electrical Impedance Tomography (EIT) DEVICE

Electrical Impedance Tomography and clinical data will be recorded continuously. Corresponding data will be extracted and analyzed at five pre-defined timepoints.

Preterm infants with a gestational age < 30 0/7 weeks at birth

Eligibility Criteria

• Age: Up to 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead
• University Hospital, Zürich: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Premature Birth; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Vincenzo Cannizzaro, MD

  Newborn Research, Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland

  STUDY CHAIR

Central Study Contacts

Christoph M Rüegger, MD

CONTACT

+41432539810; christoph.rueegger@usz.ch

Claudia Knöpfli

CONTACT

+41442555340; claudia.knoepfli@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)