Early Prediction of Lung Injury in Preterm Infants Score

NCT07265583 | Recruiting

• 1 other identifier: EPLIPS
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Distress Syndrome RDS; Preterm Birth

Keywords

Respiratory distress syndrome RDS; preterm neonate

Outcome Measures

Primary Outcomes (1)

• The prognostic value of homogeneity of ventilation assessed with EIT

  The primary objective is to measure the benefit of an earlier detection of the risk to develop BPD at 36 weeks postmenstrual age in stable preterm infants requiring non-invasive, in the first weeks of life, scoring the homogeneity of ventilation using EIT technology ventilatio measured by EIT technology, used in the first weeks of life, for the development of BPD at 36 weeks postmenstrual age

  24 months

Secondary Outcomes (3)

• changes in homogeneity at EIT

  24 months

• homogeneity at EIT are associated with BPD or death

  24 months

• EIT and LUS score

  24 months

Eligibility Criteria

• Age: 26 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

For this study we will enrol 104 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). The patients are considered eligible to be enrolled in the study if they are assisted in non-invasive ventilation (nasal continuous positive airway pressure -nCPAP- or high flow nasal -HFNC-) at 72h of life.

You may not qualify if:

• 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
• lack of parent consent.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Stefano Ghirardello, MD

  NICU, Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Ghirardello, MD

CONTACT

+3903825025218; s.ghirardello@smatteo.pv.it

Francesca Garofoli, PhD

CONTACT

+390382502865; fragarofoli@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Chief of Neonatal Unit and Neonatal Intensive care Unit

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: December 5, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

IT (1)