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

NCT07117513 | Not Yet Recruiting DMC

• 1 other identifier: EK1161/2025
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Intensive Care Units, Neonatal; Infant, Newborn; Infant, Premature; Point-of-Care Systems; Ultrasonography; Lung Ultrasound; Lung Ultrasound Score; Image Interpretation, Computer Assisted; Reproducibility of Results; Respiratory Distress Neonatal; Respiratory Support

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 1 Hour - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• cardiopulmonary malformations
• pleural effusion
• pneumothorax

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (2)

Dep. Neonatology, Medical University Graz, Austria

Graz, Styria, 8034, Austria

Location

Medical University Graz

Graz, Styria, 8034, Austria

Location

MeSH Terms

Conditions

Premature Birth; Hyaline Membrane Disease

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Bernhard Schwaberger, Prof. MD.

CONTACT

+4331638530018; bernhard.schwaberger@medunigraz.at

Melina Winkler, M.D.

CONTACT

melina.winkler@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. M.D.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: August 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: As soon as the recruitment and data analysis are completed, IPD sharing is possible on request (anticipated for May 2026 - August 2026)
• Access Criteria: please contact the PI

Locations

AU (2)