Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.
NCT ID: NCT06919757
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
54 participants
OBSERVATIONAL
2025-04-20
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
USCOM in Newly Diagnosed FGR Cases
NCT06343051
Study of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants
NCT06627374
Point of Care Lung Ultrasound in Preterm Infants with Respiratory Distress
NCT05925075
Integrated Echocardiography and Chest Ultrasound Assessment of Lung Recruitment in Preterm Infants
NCT05726578
Combined Lung Ultrasounds and Transthoracic Electrical Bioimpedance in Preterm Infants With Respiratory Distress.
NCT04359134
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Infants born preterm with history of IUGR
preterm infants with history of intrauterine growth restriction
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.
Infants born preterm without history of IUGR
preterm infants without history of intrauterine growth restriction
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Need for palliative care
* Major malformations
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stefano Nobile, MD, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fondazione Policlinico Gemelli IRCCS
Roma, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Nobile S, Marchionni P, Carnielli VP. Neonatal outcome of small for gestational age preterm infants. Eur J Pediatr. 2017 Aug;176(8):1083-1088. doi: 10.1007/s00431-017-2957-1. Epub 2017 Jun 28.
Jensen EA, Foglia EE, Dysart KC, Simmons RA, Aghai ZH, Cook A, Greenspan JS, DeMauro SB. Adverse effects of small for gestational age differ by gestational week among very preterm infants. Arch Dis Child Fetal Neonatal Ed. 2019 Mar;104(2):F192-F198. doi: 10.1136/archdischild-2017-314171. Epub 2018 May 5.
D'Agostin M, Di Sipio Morgia C, Vento G, Nobile S. Long-term implications of fetal growth restriction. World J Clin Cases. 2023 May 6;11(13):2855-2863. doi: 10.12998/wjcc.v11.i13.2855.
Arigliani M, Stocco C, Valentini E, De Pieri C, Castriotta L, Ferrari ME, Canciani C, Driul L, Orsaria M, Cattarossi L, Cogo P. Lung function between 8 and 15 years of age in very preterm infants with fetal growth restriction. Pediatr Res. 2021 Sep;90(3):657-663. doi: 10.1038/s41390-020-01299-0. Epub 2021 Jan 19.
Nobile S, Marchionni P, Gidiucci C, Correani A, Palazzi ML, Spagnoli C, Rondina C; Marche Neonatal Network; Carnielli VP. Oxygen saturation/FIO2 ratio at 36 weeks' PMA in 1005 preterm infants: Effect of gestational age and early respiratory disease patterns. Pediatr Pulmonol. 2019 May;54(5):637-643. doi: 10.1002/ppul.24265. Epub 2019 Jan 27.
Salem Y, Willers CC, Amylidi-Mohr S, Kentgens AC, Stranzinger E, Latzin P, Raio L, Yammine S. Low Birth Weight and Impaired Later Lung Function: Results from a Monochorionic Twin Study. Ann Am Thorac Soc. 2022 Nov;19(11):1856-1864. doi: 10.1513/AnnalsATS.202112-1349OC.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6642
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.