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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06919757
Acronym
ELFIGO
Enrollment
54
Registered
2025-04-09
Start date
2025-04-20
Completion date
2027-03-31
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Growth Retardation (IUGR), Lung Function Tests, Preterm Infant, Respiratory Monitoring

Keywords

lung volume measurements, pulmonary function test, preterm birth, intrauterine growth retardation, oxygen saturation/physiology

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.

Interventions

DIAGNOSTIC_TESTfetal ultrasound to assess lungs, heart and diaphragm

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.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bronchopulmonary dysplasia36 weeks post-menstrual ageRespiratory support at 36 weeks post-menstrual age
Death2 years of lifeoccurrence of death during NICU admission or afterwards
Lung function data2 years of lifeData from the Tidal breathing flow volume test and multiple breath nitrogen washout

Secondary

MeasureTime frameDescription
Peripheral oxygen saturation/fraction on inspired oxygen ratio (SFR)16 weeks of lifenon-invasive ratio between peripheral oxygen saturation/fraction on inspired oxygen ratio
Peripheral oxygen saturation/fraction on inspired oxygen ratio divided by mean airway pressure (SFR/P)16 weeks of lifenon-invasive ratio between peripheral oxygen saturation/fraction on inspired oxygen ratio and mean airway pressure

Countries

Italy

Contacts

Primary ContactStefano Nobile, MD, PhD, MSc
stefano.nobile@policlinicogemelli.it+390630156937

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026