Heterogeneity Index in Neonatologist-performed Lung Ultrasound in Neonates Receiving Respiratory Support - a Pilot Study (NPLUS HI)

Medical University of Graz

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07117513

EK1161/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 hour to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

term-born neonates and preterm neonates with respiratory support

Description:

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