Clinical Trial

Early Prediction of Lung Injury in Preterm Infants Score

Study acronym: EPLIPS
Recruiting
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Record status
This record was last updated December 5, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The main hypothesis is that even preterm infants considered "stable" receiving non-invasive ventilation may be at risk of developing BPD due to an inhomogeneous distribution of ventilation. Identifying this characteristic from the first days of life by using EIT could, in the future, optimize non-invasive ventilation strategies as early as possible, such as lung recruitment manoeuvres, which are currently mainly used during invasive mechanical ventilation. In addition, comparing the LUS scores and homogeneity parameters derived from the EIT may help to further confirm the role of semi-quantitative lung ultrasound as a rapid, non-invasive, and readily available tool in NICUs for monitoring the lung function of preterm infants in the short and long term. The primary objective is to measure homogeneity by Electrical Impedance Tomography (EIT) technology, used in the first weeks of life, for the development of BPD of grade 3, at 36 weeks postmenstrual age or death, in stable preterm infants requiring non-invasive ventilation. The secondary objective are to score if homogeneity at EIT are present and whether if they are associated with BPD. to ompare the distribution of regional lung ventilation obtained by EIT with the validated LUS scores.
Trial Details
NCT Number NCT07265583
Lead Sponsor Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions Respiratory Distress Syndrome RDS, Preterm Birth
Enrollment 104 participants
Start Date 2025-10-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-05