Actively Recruiting
Early Prediction of Lung Injury in Preterm Infants Score
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-12-05
104
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Prediction of Lung Injury in Preterm Infants Score
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants born between 26 and 32 weeks of gestational age and/or with a birth weight under 1500g
- Diagnosis of respiratory distress syndrome (RDS)
- Receiving non-invasive ventilation (nCPAP or HFNC) at 72 hours of life
- Stabilized after delivery and meeting local clinical care standards
- Parental informed consent obtained
You will not qualify if you...
- Infants born outside the study hospital (outborn)
- Complex congenital malformations
- Metabolic, chromosomal, or other genetic abnormalities
- Pulmonary hypoplasia or congenital surfactant protein abnormalities
- Any skin anomalies
- Need for mechanical ventilation exceeding 72 hours after birth
- Life-threatening comorbidities or other medical conditions making participation unsuitable
- Lack of parental consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
Research Team
S
Stefano Ghirardello, MD
CONTACT
F
Francesca Garofoli, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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