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Clinical Trials in Italy / NCT07265583
Recruiting Observational

Early Prediction of Lung Injury in Preterm Infants Score

NCT07265583 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Observational
Started
2025-10-01
Last updated
2025-12-05

Condition(s) studied

Respiratory Distress Syndrome RDSPreterm Birth

Study 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.

Eligibility

Sex
ALL
Min age
26 Weeks
Max age
32 Weeks
Healthy volunteers
No
Inclusion Criteria: preterm infants born between 26 and 32 weeks of gestational age and/or with a birth weight \< 1500g (very low birth weight infants - VLBW) with respiratory distress syndrome (RDS). \- Exclusion Criteria: - outborn infants * complex congenital malformations * metabolic, chromosomal, or other genetic abnormalities * pulmonary hypoplasia, congenital anomalies of surfactant proteins or other pulmonary abnormalities * any skin anomalies * need for mechanical ventilation \> 72h after birth * any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion. * lack of parent consent.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Policlinico San Matteo Pavia Italy Recruiting

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Other trials for the same condition

Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth Recruiting
The Placental Secretome as a Therapeutic Tool to Prevent Inflammation-induced Preterm Birth Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07265583 on ClinicalTrials.gov ↗ ← All trials in Italy