Infant, PretermINSPIRENCT07237139
Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation
An observational study of Infant, Preterm and Respiratory Distress Syndrome (Neonatal), run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 4 weeks
- Conditions the study is for
- Infant, Preterm, Respiratory Distress Syndrome (Neonatal), Chronic Lung Disease of Newborn
- What is being tested?
- Electrical Impedance Tomography (EIT)
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Nov 2025to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Severe congenital malformation adversely affecting lung aeration or perfusion (e.g., congenital heart defects)
- Too ill/unstable in the opinion of the treating physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Christoph M Rüegger, MD, +41432539810, christoph.rueegger@usz.ch
Claudia Knöpfli, +41 44 255 53 40, claudia.knoepfli@usz.ch
About this study
Official title: 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.
Read the 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).
- 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.
- Conditions
- Infant, Preterm, Respiratory Distress Syndrome (Neonatal), Chronic Lung Disease of Newborn, Respiratory Support, Synchronized Noninvasive Positive Pressure Ventilation (SNIPPV), Lung Volume
- Being tested
- Electrical Impedance Tomography (EIT)
- Keywords
- Synchronized noninvasive positive pressure ventilation (SNIPPV), Lung volume, Electrical Impedance Tomography (EIT), infant, preterm
- Medical subject headings
- Premature Birth, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants with a gestational age < 30 0/7 weeks at birth | Infants on sNIPPV respiratory support and below 4 weeks chronological age Receives: Device: Electrical Impedance Tomography (EIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume (VT)
Difference in relative VT (rel. ΔZ) between spontaneous breaths and synchronized inflations.
Measured: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Secondary outcomes (12)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Continuous measurement during the 180-minute recording period.
Peripheral oxygen saturation
Changes in oxygen saturation between five pre-defined time points.
Measured: Continuous measurement during the 180-minute recording period.
Oxygen supplementation
Changes in FiO2 between five pre-defined time points.
Measured: Continuous measurement during the 180-minute recording period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start17 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Vincenzo Cannizzaro, MD, Study chair, Newborn Research, Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237139
- Sponsor's protocol ID
- INSPIRE
- Acronym
- INSPIRE
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapulmonary Volume Changes During Synchronized Noninvasive Positive Pressure Ventilation In Preterm Infants
- ClinicalTrials.gov ID
- NCT07237139
- Acronym / sponsor ID
- INSPIRE / INSPIRE
- Conditions
- Infant, Preterm, Respiratory Distress Syndrome (Neonatal), Chronic Lung Disease of Newborn, Respiratory Support, Synchronized Noninvasive Positive Pressure Ventilation (SNIPPV), Lung Volume
- Keywords
- Synchronized noninvasive positive pressure ventilation (SNIPPV), Lung volume, Electrical Impedance Tomography (EIT), infant, preterm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants with a gestational age < 30 0/7 weeks at birth | – | Device: Electrical Impedance Tomography (EIT)Infants on sNIPPV respiratory support and below 4 weeks chronological age |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Severe congenital malformation adversely affecting lung aeration or perfusion (e.g., congenital heart defects)
- Too ill/unstable in the opinion of the treating physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Preterm infants with a gestational age < 30 0/7 weeks at birth |
Primary outcome
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.
12 secondary outcomes
Global lung impedance
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Regional tidal volume distribution
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Center of ventilation
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Silent spaces
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Global inhomogeneity index
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Coefficient of variation
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Inspiratory time
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Expiratory time
Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
Lung ultrasound score
Time frame: Immediately before the first infant handling as well as following electrical impedance tomography belt removal.
Heart rate
Time frame: Continuous measurement during the 180-minute recording period.
Peripheral oxygen saturation
Time frame: Continuous measurement during the 180-minute recording period.
Oxygen supplementation
Time frame: Continuous measurement during the 180-minute recording period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincenzo Cannizzaro, MD study chair
Newborn Research, Department of Neonatology, University Hospital and University of Zurich, Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Preterm and Respiratory Distress Syndrome (Neonatal), run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christoph M Rüegger, MD (+41432539810, christoph.rueegger@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume (VT) (time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.