Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06919757

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fetal ultrasound to assess lungs, heart and diaphragm

Diagnostic Test

The potential association between fetal ultrasound parameters (estimation of lung volumes, diaphragmatic thickness and contractility, cardiac thickness and kinetics), perinatal complications and respiratory function in the first years of life will be studied. Variables include: neonatal complications, non-invasive markers of respiratory status during neonatal admission (e.g. peripheral oxygen saturation/rfaction of inspired oxygen ratio among others), lung function tests in the first two years of life.

Other names: lung function tests

Primary outcomes

  1. Bronchopulmonary dysplasia

    Time frame: 36 weeks post-menstrual age

    Respiratory support at 36 weeks post-menstrual age

  2. Death

    Time frame: 2 years of life

    occurrence of death during NICU admission or afterwards

  3. Lung function data

    Time frame: 2 years of life

    Data from the Tidal breathing flow volume test and multiple breath nitrogen washout

Secondary outcomes

  1. Peripheral oxygen saturation/fraction on inspired oxygen ratio (SFR)

    Time frame: 16 weeks of life

    non-invasive ratio between peripheral oxygen saturation/fraction on inspired oxygen ratio

  2. Peripheral oxygen saturation/fraction on inspired oxygen ratio divided by mean airway pressure (SFR/P)

    Time frame: 16 weeks of life

    non-invasive ratio between peripheral oxygen saturation/fraction on inspired oxygen ratio and mean airway pressure

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Nobile, MD, PhD, MSc

CONTACT

[email protected]

+390630156937

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Early Lung Function Trajectories: Comparison Between Infants With Intrauterine Growth Restriction and Appropriately Grown Ones.

Acronym: ELFIGO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.