NCT06919757 Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.
| NCT ID | NCT06919757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Intrauterine Growth Retardation (IUGR) |
| Study Type | OBSERVATIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-04-20 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 54 participants in total. It began in 2025-04-20 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
During intrauterine life, some babies are smaller or grow less than expected. This fetal growth abnormality, called fetal growth restriction (FGR), can be diagnosed by ultrasound. Since there are currently no curative treatments for this condition, nor methods to optimize the growth of babies in the womb, the only effective strategy is intensive monitoring of fetal conditions, accompanied by early planning of delivery. The diagnosis of early FGR (i.e. diagnosed before 32 weeks of gestation) confers a greater risk of short- and long-term respiratory problems. The study aims to examine the association between parameters that can be assessed during pregnancy by ultrasound, such as the estimate of lung volumes, the thickness and contractility of the diaphragm, and cardiac kinetics, and any perinatal complications and respiratory function in the first years of life of premature infants, both with and without evidence of fetal growth pathology. Therefore, the study is divided into two phases: a prenatal and a postnatal phase. The study includes two groups of patients: 1. Study group: Fetuses and preterm infants with a prenatal history of FGR; 2. Control group: Preterm infants without a prenatal history of FGR followed during neonatal follow-up. Pregnant women with fetuses with FGR are followed at the Ultrasound clinics dedicated to Growth Pathology. These pregnancies usually receive weekly ultrasound monitoring, which includes a Doppler study of the maternal and fetal circulation and an estimate of fetal weight every two weeks. Cardiotocographic monitoring is also planned once or twice a week, depending on fetal well-being. The child will be assessed from a respiratory point of view during hospitalization and subsequently in the outpatient clinic, as required by clinical practice. He/she will undergo respiratory function tests. Visits are scheduled at 3, 6, 12 and 24 months of corrected age, during which at least two respiratory function tests will be performed. In addition, routine clinical data (personal data, medical history, blood tests, biological and instrumental tests) present in the medical record of the child will be collected. Data from preterm infants without fetal growth restriction will be collected after informed consent. These infants are routinely followed at our Institution and undergo clinical assessment and lung function tests in the first two years of life as previously indicated.
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
Contact & Investigator
Stefano Nobile, MD, PhD, MSc
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06919757 clinical trial?
This trial is open to participants of all sexes, studying Intrauterine Growth Retardation (IUGR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06919757 currently recruiting?
Yes, NCT06919757 is actively recruiting participants. Contact the research team at stefano.nobile@policlinicogemelli.it for enrollment information.
Where is the NCT06919757 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06919757 clinical trial?
NCT06919757 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Stefano Nobile, MD, PhD, MSc at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 54 participants.