Early prediction of lung injury in very preterm infants using EIT and lung ultrasound

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting Adverse Pregnancy Outcomes in Uganda through Partnerships and Innovation

  This study tests whether everyday health data, ultrasound, and blood samples from first-time pregnant women in Uganda can help predict problems like preeclampsia, fetal growth restriction, and preterm birth.

  Recruiting at 2 sites Makerere University · Kampala and 1 other locations · NCT07844876

• Cervical stiffness test to help predict preterm birth in at-risk pregnant women

  A simple cervical stiffness test using the Pregnolia device is being studied to see if it can better identify women with threatened preterm labor who are likely to give birth soon.

  Recruiting Pregnolia AG · Prague · NCT07840235

• Prenatal education to reduce environmental exposures during pregnancy

  Aimed at pregnant people, this program tests whether a classroom-style education can help reduce exposure to harmful pollutants from seafood and nearby pollution sources.

  Recruiting at 2 sites The University of Texas Medical Branch, Galveston · Galveston, Texas and 1 other locations · NCT07758114

• How doctors and nurses decide about bed rest in pregnancy

  This study tests a plan to stop routinely restricting activity or bed rest during pregnancy to see if providers accept it, find it appropriate, and change how often they recommend it for women at risk of preterm birth.

  Recruiting at 2 sites University of Pennsylvania · Philadelphia, Pennsylvania and 1 other locations · NCT07698483

• How cervical ultrasound settings affect AI prediction of preterm birth

  This study tests whether an AI model for predicting preterm birth performs differently when cervical ultrasound images are taken with different imaging settings.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen · NCT07598097

• Surfactant delivery methods in preterm infants with RDS in Sweden

  This study tests different ways of giving surfactant to preterm babies with respiratory distress to see which method works best when care is routine.

  Recruiting Vastra Gotaland Region · Gothenburg · NCT07550218

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.