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

ConditionsIntensive 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

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age1-7

SponsorMedical University of Graz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

cardiopulmonary malformations

pleural effusion

pneumothorax

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants

are grouped into 1 trial group

Group A: term-born neonates and preterm neonates with respiratory support

Trial outcomes

Primary outcomes

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.

Time frame

one year

Sponsors and contacts

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Medical University of Graz

Lead sponsor

Source ClinicalTrials.gov

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