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NCT Number: NCT07237139

Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation

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.

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Key information

Conditions

Infant, Preterm Chronic Lung Disease of Newborn Female Urogenital Diseases and Pregnancy Complications Lung Diseases Lung Volume Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Pulmonary Atelectasis Respiratory Distress Syndrome (Neonatal) Respiratory Support Respiratory Tract Diseases Synchronized Noninvasive Positive Pressure Ventilation (SNIPPV) Urogenital Diseases

Age range

Up to 4 week

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

  • 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.
  • 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.
  • 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) .
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Tidal volume (VT)

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

    Difference in relative VT (rel. ΔZ) between spontaneous breaths and synchronized inflations.

Secondary outcomes

  1. Global lung impedance

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

    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.

  2. Regional tidal volume distribution

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

    Difference in regional tidal distribution between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations

  3. Center of ventilation

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

    Difference in center of ventilation between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations

  4. Silent spaces

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

    Difference in silent spaces between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations

  5. Global inhomogeneity index

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

    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.

  6. Coefficient of variation

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

    Difference in coefficient of variation (EIT) between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations

  7. Inspiratory time

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

    Difference in inspiratory times between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations

  8. Expiratory time

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

    Difference in expiratory times between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations

  9. Lung ultrasound score

    Time frame: Immediately before the first infant handling as well as following electrical impedance tomography belt removal.

    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.

  10. Heart rate

    Time frame: Continuous measurement during the 180-minute recording period.

    Changes of heart rate between five pre-defined time points.

  11. Peripheral oxygen saturation

    Time frame: Continuous measurement during the 180-minute recording period.

    Changes in oxygen saturation between five pre-defined time points.

  12. Oxygen supplementation

    Time frame: Continuous measurement during the 180-minute recording period.

    Changes in FiO2 between five pre-defined time points.

Study contacts

Contact information is provided by the study sponsor or research team.

Christoph M Rüegger, MD

CONTACT

[email protected]

+41432539810

Claudia Knöpfli

CONTACT

[email protected]

+41442555340

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • University Hospital, Zürich

Registry information

Official study title

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

Acronym: INSPIRE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 19, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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