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

NCT06919757 | Recruiting

• 1 other identifier: 6642
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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. 1.Study group: Fetuses and preterm infants with a prenatal history of FGR;
2. 2.Control group: Preterm infants without a prenatal history of FGR followed during neonatal follow-up.

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

Outcome Measures

Primary Outcomes (3)

• Bronchopulmonary dysplasia

  Respiratory support at 36 weeks post-menstrual age

  36 weeks post-menstrual age

• Death

  occurrence of death during NICU admission or afterwards

  2 years of life

• Lung function data

  Data from the Tidal breathing flow volume test and multiple breath nitrogen washout

  2 years of life

Secondary Outcomes (2)

• Peripheral oxygen saturation/fraction on inspired oxygen ratio (SFR)

  16 weeks of life

• Peripheral oxygen saturation/fraction on inspired oxygen ratio divided by mean airway pressure (SFR/P)

  16 weeks of life

Study Arms (2)

Infants born preterm with history of IUGR

preterm infants with history of intrauterine growth restriction

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

Diagnostic Test: fetal ultrasound to assess lungs, heart and diaphragm

Interventions

fetal ultrasound to assess lungs, heart and diaphragm DIAGNOSTIC_TEST

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

Infants born preterm with history of IUGR; Infants born preterm without history of IUGR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction

You may qualify if:

• Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction

You may not qualify if:

• Lack of informed consent
• Need for palliative care
• Major malformations

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 28660312 BACKGROUND

• 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.

  PMID: 29730594 BACKGROUND

• 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.

  PMID: 37215406 BACKGROUND

• 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.

  PMID: 33469172 BACKGROUND

• 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.

  PMID: 30688034 BACKGROUND

• 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.

  PMID: 35580242 BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation; Premature Birth

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stefano Nobile, MD, PhD, MSc

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Nobile, MD, PhD, MSc

CONTACT

+390630156937; stefano.nobile@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

IT (1)