Intrauterine Growth Retardation (IUGR)ELFIGONCT06919757
Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.
An observational study of Intrauterine Growth Retardation (IUGR) and Lung Function Tests, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intrauterine Growth Retardation (IUGR), Lung Function Tests, Preterm Infant
- What is being tested?
- fetal ultrasound to assess lungs, heart and diaphragm
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2025to Mar 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction
Who may be able to join
- Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction
Who cannot join
- Lack of informed consent
- Need for palliative care
- Major malformations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Roma, 00168
Stefano Nobile, MD, PhD, MSc, +390630156937, stefano.nobile@policlinicogemelli.it
About this study
Official title: Early Lung Function Trajectories: Comparison Between Infants With Intrauterine Growth Restriction and Appropriately Grown Ones.
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.
Read more
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:
- Study group: Fetuses and preterm infants with a prenatal history of FGR;
- 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.
- Conditions
- Intrauterine Growth Retardation (IUGR), Lung Function Tests, Preterm Infant, Respiratory Monitoring
- Being tested
- fetal ultrasound to assess lungs, heart and diaphragm
- Keywords
- lung volume measurements, pulmonary function test, preterm birth, intrauterine growth retardation, oxygen saturation/physiology
- Medical subject headings
- Fetal Growth Retardation, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetal ultrasound to assess lungs, heart and diaphragmDiagnostic test
Also called lung function tests
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.
| Study group | Role | What they receive |
|---|---|---|
| Infants born preterm with history of IUGR | preterm infants with history of intrauterine growth restriction Receives: Diagnostic Test: fetal ultrasound to assess lungs, heart and diaphragm | |
| Infants born preterm without history of IUGR | preterm infants without history of intrauterine growth restriction Receives: Diagnostic Test: fetal ultrasound to assess lungs, heart and diaphragm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchopulmonary dysplasia
Respiratory support at 36 weeks post-menstrual age
Measured: 36 weeks post-menstrual age
Death
occurrence of death during NICU admission or afterwards
Measured: 2 years of life
Lung function data
Data from the Tidal breathing flow volume test and multiple breath nitrogen washout
Measured: 2 years of life
Secondary outcomes (2)
Peripheral oxygen saturation/fraction on inspired oxygen ratio (SFR)
non-invasive ratio between peripheral oxygen saturation/fraction on inspired oxygen ratio
Measured: 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
Measured: 16 weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start20 Apr 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Growth Retardation (IUGR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Nobile, MD, PhD, MSc, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919757
- Sponsor's protocol ID
- 6642
- Acronym
- ELFIGO
- Status last verified
- Aug 2025
- First submitted
- 2 Apr 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28660312Jensen 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.
PubMed 29730594D'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.
PubMed 37215406Arigliani 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.
PubMed 33469172Nobile 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.
PubMed 30688034Salem 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.
PubMed 35580242
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Lung Function Trajectories: Comparison Between Infants With Intrauterine Growth Restriction and Appropriately Grown Ones.
- ClinicalTrials.gov ID
- NCT06919757
- Acronym / sponsor ID
- ELFIGO / 6642
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Study group: Fetuses and preterm infants with a prenatal history of FGR;
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants born preterm with history of IUGR | – | Diagnostic Test: fetal ultrasound to assess lungs, heart and diaphragmpreterm infants with history of intrauterine growth restriction |
| Infants born preterm without history of IUGR | – | Diagnostic Test: fetal ultrasound to assess lungs, heart and diaphragmpreterm infants without history of intrauterine growth restriction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction
Key inclusion criteria (1 listed)
- Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction
Key exclusion criteria (3 listed)
- Lack of informed consent
- Need for palliative care
- Major malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fetal ultrasound to assess lungs, heart and diaphragmAlso: lung function testsThe 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. | Diagnostic test | Infants born preterm with history of IUGR, Infants born preterm without history of IUGR |
Primary outcome
Bronchopulmonary dysplasia
Time frame: 36 weeks post-menstrual age
Respiratory support at 36 weeks post-menstrual age
Death
Time frame: 2 years of life
occurrence of death during NICU admission or afterwards
Lung function data
Time frame: 2 years of life
Data from the Tidal breathing flow volume test and multiple breath nitrogen washout
2 secondary outcomes
Peripheral oxygen saturation/fraction on inspired oxygen ratio (SFR)
Time frame: 16 weeks of life
Peripheral oxygen saturation/fraction on inspired oxygen ratio divided by mean airway pressure (SFR/P)
Time frame: 16 weeks of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Background: PubMed 28660312Nobile 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.
- Background: PubMed 29730594Jensen 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.
- Background: PubMed 37215406D'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.
- Background: PubMed 33469172Arigliani 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.
- Background: PubMed 30688034Nobile 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.
- Background: PubMed 35580242Salem 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Nobile, MD, PhD, MSc principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Retardation (IUGR) and Lung Function Tests, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Nobile, MD, PhD, MSc (+390630156937, stefano.nobile@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchopulmonary dysplasia (time frame: 36 weeks post-menstrual age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06919757, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.