Intensive Care Units, NeonatalNPLUS HINCT07117513
Heterogeneity Index in Neonatologist-performed Lung Ultrasound in Neonates Receiving Respiratory Support - a Pilot Study
An observational study of Intensive Care Units, Neonatal and Infant, Newborn, run by Medical University of Graz at 2 sites in Austria.
Trial summary
Lung ultrasound is an increasingly valuable diagnostic tool in neonatal intensive care due to its safety and accessability. This pilot study investigates whether a quantitative approach - the heterogeneity index, previously only used in fetal lung assessment - can enhance the diagnostic accuracy of… Read more about this study
- Who is it for?
- Ages 1 hour to 7 days
- Conditions the study is for
- Intensive Care Units, Neonatal, Infant, Newborn, Infant, Premature
- How many people
- 40 participants
- Where
- 2 sitesAustria
- Study dates
- 15 Aug 2025to 1 Aug 2026
- 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 1 hour to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: This study will include neonates with a gestational age between 28+0 weeks and 42+0 who require either non-invasive or invasive respiratory support in the Department of Neonatology, Medical University Graz, Austria (a tertiary centre).
Who may be able to join
- Preterm neonates born between 28+0 and 36+6 weeks of gestation and term-born neonates (> 37+0 weeks of gestation) admitted to the NICU
- Presence of respiratory distress requiring respiratory support (invasive and non-invasive) at the timepoint of NPLUS 1.
- Written informed consent obtained from the parents prior to the measurement.
Who cannot join
- cardiopulmonary malformations
- pleural effusion
- pneumothorax
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Melina Winkler, M.D. contact
Austria2 sites
Dep. Neonatology, Medical University Graz, Austria
Graz, Styria, 8034
Medical University Graz
Graz, Styria, 8034
About this study
Lung ultrasound is an increasingly valuable diagnostic tool in neonatal intensive care due to its safety and accessability.
This pilot study investigates whether a quantitative approach - the heterogeneity index, previously only used in fetal lung assessment - can enhance the diagnostic accuracy of neonatologist-performed lung ultrasound (NPLUS). The index will be calculated from raw ultrasound images of preterm and term neonates and compared with conventional lung ultrasound scores to evaluate its clinical relevance.
Read the detailed description
Lung ultrasound is gaining importance in intensive care medicine, particularly in neonatology, as a rapidly available, and radiation-free alternative to X-ray imaging. Neonatologist-performed lung ultrasound (NPLUS) enables reliable diagnosis of various respiratory conditions in both preterm and term neonates.
It relies on interpreting ultrasound artifacts, pleural line analysis, and detecting consolidations or effusions, thus significantly improving differential diagnosis of neonatal respiratory symptoms. Semi-quantitative lung ultrasound scoring systems have been developed to assess pulmonary aeration patterns and guide clinical decisions-e.g., detecting surfactant deficiency in preterm infants or identifying 'wet lung' in term neonates.
However, subtle sonographic changes related to respiratory symptoms may not be adequately captured on the current 0-3 scale and are subject to interobserver variability. In obstetrics, a heterogeneity index has been introduced to quantitatively assess fetal lung texture with high diagnostic accuracy for postnatal respiratory outcomes.
This study aims to introduce a quantitative ultrasound method into clinical routine to improve diagnostic precision in NPLUS. To our knowledge, this approach has not yet been applied in this context.
In this pilot study, 20 preterm (28+0 to 36+6 weeks) and 20 term (≥37+0 weeks) neonates receiving non-invasive or invasive respiratory support in the NICU will undergo NPLUS at two time points. From the raw ultrasound data, a mean pixel value will be calculated to derive the heterogeneity index, which will then be compared to the traditional lung ultrasound score to assess its clinical relevance.
- Conditions
- Intensive Care Units, Neonatal, Infant, Newborn, Infant, Premature, Point-of-Care Systems, Ultrasonography, Lung Ultrasound
- Keywords
- Neonatologist-Performed Lung Ultrasound, Lung Ultrasound, Lung Ultrasound Score, Quantitative Lung Ultrasound, Neonatal Intensive Care Unit, Observer Variability in Imaging, Ultrasound Artifact Interpretation, Respiratory Distress Syndrome in Neonates, respiratory support, preterm neonate, newborn
- Medical subject headings
- Premature Birth, Hyaline Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| term-born neonates and preterm neonates with respiratory support | term-born neonates (37 and more weeks' gestational age) and preterm neonates (28+0-36+6 weeks' gestational age) with respiratory support either invasive or non-invasive admitted to the NICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the heterogeneity index of NPLUS 1 and NPLUS 2
A medical professional will perform the NPLUS (Neontaologist-performed lung ultrasound) at predefined time points after birth: NPLUS 1 within 72 hours of birth and NPLUS 2 within 72 hours (minimum 24 hours) after the first examination.
The raw ultrasound images will be reviewed by a trained medical professional. A region of interest (ROI) will be manually selected in each lung area that should be analysed. Each ROI will be a square that includes the largest possible area with lung artefacts, starting from the pleura and excluding subcutaneous tissue.
The grayscale-based analysis will be performed using a custom-made program developed in MATLAB. Texture features in the lung tissue will be related to pathophysiologic processes. The heterogeneity index will then be determined by measuring the intensity of each pixel and calculating the average of all pixel within the ROI.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Units, NeonatalStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard Schwaberger, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117513
- Sponsor's protocol ID
- EK1161/2025
- Acronym
- NPLUS HI
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: on request
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heterogeneity Index in Neonatologist-performed Lung Ultrasound in Neonates Receiving Respiratory Support - a Pilot Study
- ClinicalTrials.gov ID
- NCT07117513
- Acronym / sponsor ID
- NPLUS HI / EK1161/2025
- Conditions
- Intensive Care Units, Neonatal, Infant, Newborn, Infant, Premature, Point-of-Care Systems, Ultrasonography, Lung Ultrasound
- Keywords
- Neonatologist-Performed Lung Ultrasound, Lung Ultrasound, Lung Ultrasound Score, Quantitative Lung Ultrasound, Neonatal Intensive Care Unit, Observer Variability in Imaging, Ultrasound Artifact Interpretation, Respiratory Distress Syndrome in Neonates
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 12 Aug 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.
Lung ultrasound is an increasingly valuable diagnostic tool in neonatal intensive care due to its safety and accessability.
This pilot study investigates whether a quantitative approach - the heterogeneity index, previously only used in fetal lung assessment - can enhance the diagnostic accuracy of neonatologist-performed lung ultrasound (NPLUS). The index will be calculated from raw ultrasound images of preterm and term neonates and compared with conventional lung ultrasound scores to evaluate its clinical relevance.
Detailed description
Lung ultrasound is gaining importance in intensive care medicine, particularly in neonatology, as a rapidly available, and radiation-free alternative to X-ray imaging. Neonatologist-performed lung ultrasound (NPLUS) enables reliable diagnosis of various respiratory conditions in both preterm and term neonates.
It relies on interpreting ultrasound artifacts, pleural line analysis, and detecting consolidations or effusions, thus significantly improving differential diagnosis of neonatal respiratory symptoms. Semi-quantitative lung ultrasound scoring systems have been developed to assess pulmonary aeration patterns and guide clinical decisions-e.g., detecting surfactant deficiency in preterm infants or identifying 'wet lung' in term neonates.
However, subtle sonographic changes related to respiratory symptoms may not be adequately captured on the current 0-3 scale and are subject to interobserver variability. In obstetrics, a heterogeneity index has been introduced to quantitatively assess fetal lung texture with high diagnostic accuracy for postnatal respiratory outcomes.
This study aims to introduce a quantitative ultrasound method into clinical routine to improve diagnostic precision in NPLUS. To our knowledge, this approach has not yet been applied in this context.
In this pilot study, 20 preterm (28+0 to 36+6 weeks) and 20 term (≥37+0 weeks) neonates receiving non-invasive or invasive respiratory support in the NICU will undergo NPLUS at two time points. From the raw ultrasound data, a mean pixel value will be calculated to derive the heterogeneity index, which will then be compared to the traditional lung ultrasound score to assess its clinical relevance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| term-born neonates and preterm neonates with respiratory support | – | –term-born neonates (37 and more weeks' gestational age) and preterm neonates (28+0-36+6 weeks' gestational age) with respiratory support either invasive or non-invasive admitted to the NICU |
Who may qualify
- Ages
- 1 hour to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will include neonates with a gestational age between 28+0 weeks and 42+0 who require either non-invasive or invasive respiratory support in the Department of Neonatology, Medical University Graz, Austria (a tertiary centre).
Key inclusion criteria (3 listed)
- Preterm neonates born between 28+0 and 36+6 weeks of gestation and term-born neonates (> 37+0 weeks of gestation) admitted to the NICU
- Presence of respiratory distress requiring respiratory support (invasive and non-invasive) at the timepoint of NPLUS 1.
- Written informed consent obtained from the parents prior to the measurement.
Key exclusion criteria (3 listed)
- cardiopulmonary malformations
- pleural effusion
- pneumothorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of the heterogeneity index of NPLUS 1 and NPLUS 2
Time frame: one year
A medical professional will perform the NPLUS (Neontaologist-performed lung ultrasound) at predefined time points after birth: NPLUS 1 within 72 hours of birth and NPLUS 2 within 72 hours (minimum 24 hours) after the first examination. The raw ultrasound images will be reviewed by a trained medical professional. A region of interest (ROI) will be manually selected in each lung area that should be analysed. Each ROI will be a square that includes the largest possible area with lung artefacts, starting from the pleura and excluding subcutaneous tissue. The grayscale-based analysis will be performed using a custom-made program developed in MATLAB. Texture features in the lung tissue will be related to pathophysiologic processes. The heterogeneity index will then be determined by measuring the intensity of each pixel and calculating the average of all pixel within the ROI.
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 12 Aug 2025.
- Individual participant dataSharing planned: Yes. on request
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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.
Melina Winkler, M.D. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Units, Neonatal and Infant, Newborn, run by Medical University of Graz at 2 sites in Austria.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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 Bernhard Schwaberger, Prof. MD. (+4331638530018, bernhard.schwaberger@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the heterogeneity index of NPLUS 1 and NPLUS 2 (time frame: one year). 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 12 Aug 2025.