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Search / Trial NCT06919757

Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Apr 2, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Lung Volume Measurements Pulmonary Function Test Preterm Birth Intrauterine Growth Retardation Oxygen Saturation/Physiology

ClinConnect Summary

This clinical trial is studying how being smaller than expected while growing in the womb, a condition called intrauterine growth restriction (IUGR), affects lung function in premature infants. The researchers want to understand the relationship between ultrasound measurements taken during pregnancy—like how well the baby's lungs are developing and how well the diaphragm (a muscle important for breathing) is working—and any respiratory problems these babies may face in their early years. The study includes two groups: one group of babies who had IUGR and another group of babies who developed normally.

To be eligible for the trial, participants must be fetuses or infants born before 32 weeks of pregnancy, regardless of whether they had growth issues. The mothers of eligible babies will have regular ultrasounds to monitor their health during pregnancy, and once the babies are born, their lung function will be tested at different ages up to two years old. This study aims to help improve our understanding of how IUGR impacts a child’s breathing and overall health, even if there are currently no treatments to prevent this condition. Parents will be informed and asked for consent before participation, ensuring they understand what to expect throughout the process.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction
  • Exclusion Criteria:
  • Lack of informed consent
  • Need for palliative care
  • Major malformations

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Stefano Nobile, MD, PhD, MSc

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported