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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bernhard Schwaberger, Prof. MD. | Contact | +4331638530018 | bernhard.schwaberger@medunigraz.at | |
| Melina Winkler, M.D. | Contact | melina.winkler@medunigraz.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. Neonatology, Medical University Graz, Austria | Graz | Styria | 8034 | Austria | ||
| Medical University Graz |
on request
As soon as the recruitment and data analysis are completed, IPD sharing is possible on request (anticipated for May 2026 - August 2026)
please contact the PI
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2025 |
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| Graz |
| Styria |
| 8034 |
| Austria |
| Aug 5, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D006819 | Hyaline Membrane Disease |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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