An observational study in Intrauterine Growth Retardation (IUGR), Lung Function Tests and Preterm Infant, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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:
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.
264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.
This study's planned enrollment of 54 is below the median of 161 across 142 observational studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction
Exclusion Criteria:
preterm infants with history of intrauterine growth restriction
Diagnostic Test: fetal ultrasound to assess lungs, heart and diaphragm
preterm infants without history of intrauterine growth restriction
Diagnostic Test: fetal 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.
Also known as: lung function tests
Bronchopulmonary dysplasia
Respiratory support at 36 weeks post-menstrual age
Time frame: 36 weeks post-menstrual age
Death
occurrence of death during NICU admission or afterwards
Time frame: 2 years of life
Lung function data
Data from the Tidal breathing flow volume test and multiple breath nitrogen washout
Time frame: 2 years of life
Peripheral oxygen saturation/fraction on inspired oxygen ratio (SFR)
non-invasive ratio between peripheral oxygen saturation/fraction on inspired oxygen ratio
Time frame: 16 weeks of life
Peripheral oxygen saturation/fraction on inspired oxygen ratio divided by mean airway pressure (SFR/P)
non-invasive ratio between peripheral oxygen saturation/fraction on inspired oxygen ratio and mean airway pressure
Time frame: 16 weeks of life
Plan to share: Undecided
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS