Early lung development in preterm babies with and without fetal growth restriction
Official title: Early Lung Function Trajectories: Comparison Between Infants With Intrauterine Growth Restriction and Appropriately Grown Ones.
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06919757 · Data updated 2026-11-12
This study will test whether ultrasound measurements of fetal lung volume, diaphragm thickness and heart function before 32 weeks can help predict breathing problems and later lung function in preterm babies with or without fetal growth restriction.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | April 20, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT06919757 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are fetuses and infants born before 32 weeks of gestation, with or without fetal growth restriction, whose parents provide informed consent and who do not have major malformations or need palliative care.
✕Probably not a fit
Patients unlikely to benefit include those receiving palliative care, those with major congenital malformations, and infants born at or after 32 weeks of gestation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study follows fetuses diagnosed before 32 weeks and the infants they become, comparing those with fetal growth restriction to those without. Investigators will perform prenatal ultrasound measurements of lung volumes, diaphragm thickness and contractility, and cardiac kinetics, then record perinatal complications and respiratory outcomes after birth. Pulmonary function tests and oxygenation/respiratory monitoring will be used in the neonatal period and early childhood to link prenatal measures with later lung function. No interventional therapy is assigned; the study aims to identify ultrasound markers that correlate with respiratory risk in prematurity.
Why it matters
Potential benefit: If successful, the findings could help identify which preterm infants are at higher risk for breathing problems so clinicians can target monitoring and early respiratory care.
How similar studies have gone: Prior studies have linked fetal growth restriction to worse respiratory outcomes and some small studies suggest prenatal lung measurements relate to neonatal respiratory status, but large prospective comparisons remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Fondazione Policlinico Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Stefano Nobile, MD, PhD, MSc — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Stefano Nobile, MD, PhD, MSc
- Email: stefano.nobile@policlinicogemelli.it
- Phone: +390630156937
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.