About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction
Disqualifiers
Lack of informed consent
Need for palliative care
Major malformations
Trial population
Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction
Trial design
Case-control
Prospective
Treatments tested in this trial
fetal ultrasound to assess lungs, heart and diaphragm
Diagnostic testThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Bronchopulmonary dysplasia
Respiratory support at 36 weeks post-menstrual age
Death
occurrence of death during NICU admission or afterwards
Lung function data
Data from the Tidal breathing flow volume test and multiple breath nitrogen washout
Secondary outcomes
Peripheral oxygen saturation/fraction on inspired oxygen ratio (SFR)
non-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)
non-invasive ratio between peripheral oxygen saturation/fraction on inspired oxygen ratio and mean airway pressure
Sponsors and contacts
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