Actively Recruiting

Age: 0 - 4Weeks
All Genders
ID07237139

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

Led by University of Zurich · Updated on 2025-12-09

27

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Zurich

Lead Sponsor

U

University Hospital, Zürich

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying lung volume changes in preterm infants receiving synchronized noninvasive positive pressure ventilation (sNIPPV) for respiratory distress syndrome and other lung conditions. This observational study aims to understand how synchronized breaths affect lung aeration compared to non-synchronized or backup inflations, using Electrical Impedance Tomography (EIT) to measure these effects. The goal is to clarify the intrapulmonary mechanisms behind sNIPPV's benefits in preventing respiratory failure. Participants will have an EIT belt and pulse oximeter sensor attached during a nursing care session. The study involves switching ventilation modes between sNIPPV and continuous positive airway pressure (CPAP) to record lung function during spontaneous, synchronized, non-synchronized, and backup breaths. Measurements are taken at multiple predefined timepoints over a 180-minute recording period, with ventilator settings held constant throughout. During the study, lung volume changes, regional aeration, heart rate, oxygen levels, and lung ultrasound scores will be continuously monitored and analyzed. The EIT device records lung impedance and ventilation distribution to assess breathing patterns. Data collection concludes after the next nursing session when sensors are removed. This process helps researchers evaluate how different ventilation modes impact lung function in very young preterm infants.

CONDITIONS

Brief Title

Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation

Who Can Participate

Age: 0 - 4Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent by one or both parents or legal guardians
  • Gestational age at birth less than 30 0/7 weeks
  • Infants receiving synchronized noninvasive positive pressure ventilation (sNIPPV)
  • Chronological age below 4 weeks
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 1 nursing care session

Participants will have an Electrical Impedance Tomography (EIT) belt and a pulse oximeter sensor attached during the final nursing care session before the study begins.

1 visit (in-person)

Monitoring

Duration - 3 hours

Participants will be observed continuously while receiving synchronized noninvasive positive pressure ventilation (sNIPPV). Lung volume changes and respiratory parameters will be recorded over a 180-minute period including baseline spontaneous breathing periods using CPAP.

Continuous monitoring during 1 visit

Trial Site Locations

Total: 1 location

1

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland, 8091

Actively Recruiting

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Research Team

C

Christoph M Rüegger, MD

C

Claudia Knöpfli

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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