Early prediction of lung injury in very preterm infants using EIT and lung ultrasound
Electrical Impedance Tomography and Lung Ultrasound Score in Early Prediction of Bronchopulmonary Dysplasia in Preterm and Very Low Birth Weight Infants.
This project will test whether bedside Electrical Impedance Tomography (EIT) and lung ultrasound in stable preterm babies on non-invasive breathing support can spot uneven lung ventilation that predicts severe BPD or death by 36 weeks postmenstrual age.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 26 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT07265583 on ClinicalTrials.gov |
What this trial studies
This observational project will enroll 104 very preterm infants (26–32 weeks' gestation and/or birthweight <1500 g) with respiratory distress syndrome who remain on non-invasive ventilation (nCPAP or HFNC) at 72 hours of life at the NICU in Pavia, Italy. Investigators will perform bedside Electrical Impedance Tomography (EIT) during the first weeks of life to quantify ventilation homogeneity and will collect standard lung ultrasound (LUS) scores. EIT-derived homogeneity parameters and LUS scores will be compared with clinical outcomes, specifically bronchopulmonary dysplasia grade 3 at 36 weeks postmenstrual age or death, to see if early ventilation inhomogeneity predicts later severe lung injury. All measurements are observational, will not alter routine care, and enrollment will be consecutive with informed parental consent.
Who should consider this trial
Good fit: Ideal candidates are inborn very preterm infants (26–32 weeks' gestation and/or birthweight <1500 g) with respiratory distress syndrome who are on nCPAP or HFNC at 72 hours of life and whose parents provide consent.
Not a fit: Infants who are outborn, intubated and mechanically ventilated for more than 72 hours, have major congenital or genetic anomalies, skin conditions preventing EIT, or other life‑threatening comorbidities are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, early detection of uneven ventilation could let clinicians tailor non-invasive support sooner and may reduce the risk of severe BPD.
How similar studies have performed: Prior neonatal work has used EIT and lung ultrasound to monitor regional aeration and ventilation, but using early EIT homogeneity measures specifically to predict severe BPD is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pavia
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
Study contacts
- Principal investigator: Stefano Ghirardello, MD — NICU, Fondazione IRCCS Policlinico San Matteo
- Study coordinator: Stefano Ghirardello, MD
- Email: s.ghirardello@smatteo.pv.it
- Phone: +3903825025218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.