Recruiting

ELFIGOLung Function in Infants with Intrauterine Growth Restriction

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases+9

+ Female Urogenital Diseases and Pregnancy Complications

+ Fetal Diseases

+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: April 2025
See protocol details

Summary

Principal SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ContactStefano Nobile, MD, PhD, MSc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 20, 2025

Actual date on which the first participant was enrolled.

This study focuses on babies who are smaller or grow less than expected during pregnancy, a condition known as fetal growth restriction (FGR). FGR is diagnosed by ultrasound and can lead to short- and long-term respiratory problems, especially when diagnosed before 32 weeks of pregnancy. The study aims to understand the link between certain parameters assessed during pregnancy, such as lung volumes, diaphragm thickness, and cardiac kinetics, and any respiratory complications in the first years of life. The study involves two groups: fetuses and preterm infants with a history of FGR, and preterm infants without a history of FGR. The study is important as it could help improve care and address challenges related to FGR and respiratory issues in preterm infants. Pregnant women with fetuses diagnosed with FGR are monitored closely, with weekly ultrasounds and other tests to check fetal well-being. After birth, the child's respiratory function is assessed during hospitalization and in subsequent outpatient visits. These assessments include respiratory function tests at 3, 6, 12, and 24 months of corrected age. The study also collects routine clinical data from the child's medical record. For preterm infants without FGR, similar data is collected after obtaining informed consent. The study measures outcomes such as the need for respiratory support at 36 weeks post-menstrual age, occurrence of death during NICU admission or afterwards, and lung function data from certain tests.

Official TitleEarly Lung Function Trajectories: Comparison Between Infants With Intrauterine Growth Restriction and Appropriately Grown Ones.
Principal SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ContactStefano Nobile, MD, PhD, MSc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsFetal DiseasesFetal Growth RetardationGrowth DisordersObstetric Labor ComplicationsObstetric Labor, PrematureCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPregnancy ComplicationsPathological Conditions, Signs and SymptomsPremature Birth

Criteria

1 inclusion criteria required to participate
Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction

3 exclusion criteria prevent from participating
Lack of informed consent

Need for palliative care

Major malformations

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fondazione Policlinico Gemelli IRCCS

Roma, ItalyOpen Fondazione Policlinico Gemelli IRCCS in Google Maps
Recruiting
One Study Center