Heterogeneity Index in Neonatologist-performed Lung Ultrasound in Neonates Receiving Respiratory Support - a Pilot 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.

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Key information

Conditions

Intensive Care Units, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Hyaline Membrane Disease Image Interpretation, Computer Assisted Infant, Newborn Infant, Newborn, Diseases Infant, Premature Infant, Premature, Diseases Lung Diseases Lung Ultrasound Lung Ultrasound Score Obstetric Labor Complications Obstetric Labor, Premature Point-of-Care Systems Pregnancy Complications Premature Birth Reproducibility of Results Respiration Disorders Respiratory Distress Neonatal Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Support Respiratory Tract Diseases Ultrasonography Urogenital Diseases

Age range

1 hour–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. Neonatology, Medical University Graz, Austria, Graz, Styria, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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.

Exclusion criteria

cardiopulmonary malformations
pleural effusion
pneumothorax

Treatment and study plan

Primary outcomes

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.

Study contacts

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

Bernhard Schwaberger, Prof. MD.

CONTACT

[email protected]

+4331638530018

Melina Winkler, M.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Acronym: NPLUS HI

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Aug 12, 2025
Registry last updated: Aug 12, 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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