Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 6:20 AM
Study NCT ID:
NCT06919757
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bronchopulmonary dysplasia', 'timeFrame': '36 weeks post-menstrual age', 'description': 'Respiratory support at 36 weeks post-menstrual age'}, {'measure': 'Death', 'timeFrame': '2 years of life', 'description': 'occurrence of death during NICU admission or afterwards'}, {'measure': 'Lung function data', 'timeFrame': '2 years of life', 'description': 'Data from the Tidal breathing flow volume test and multiple breath nitrogen washout'}], 'secondaryOutcomes': [{'measure': 'Peripheral oxygen saturation/fraction on inspired oxygen ratio (SFR)', 'timeFrame': '16 weeks of life', 'description': 'non-invasive ratio between peripheral oxygen saturation/fraction on inspired oxygen ratio'}, {'measure': 'Peripheral oxygen saturation/fraction on inspired oxygen ratio divided by mean airway pressure (SFR/P)', 'timeFrame': '16 weeks of life', 'description': 'non-invasive ratio between peripheral oxygen saturation/fraction on inspired oxygen ratio and mean airway pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung volume measurements', 'pulmonary function test', 'preterm birth', 'intrauterine growth retardation', 'oxygen saturation/physiology'], 'conditions': ['Intrauterine Growth Retardation (IUGR)', 'Lung Function Tests', 'Preterm Infant', 'Respiratory Monitoring']}, 'referencesModule': {'references': [{'pmid': '28660312', 'type': 'BACKGROUND', 'citation': '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': '29730594', 'type': 'BACKGROUND', 'citation': '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': '37215406', 'type': 'BACKGROUND', 'citation': "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': '33469172', 'type': 'BACKGROUND', 'citation': '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': '30688034', 'type': 'BACKGROUND', 'citation': "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': '35580242', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe diagnosis of early FGR (i.e. diagnosed before 32 weeks of gestation) confers a greater risk of short- and long-term respiratory problems.\n\nThe 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.\n\nThe study includes two groups of patients:\n\n1. Study group: Fetuses and preterm infants with a prenatal history of FGR;\n2. Control group: Preterm infants without a prenatal history of FGR followed during neonatal follow-up.\n\nPregnant women with fetuses with FGR are followed at the Ultrasound clinics dedicated to Growth Pathology.\n\nThese 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.\n\nThe child will be assessed from a respiratory point of view during hospitalization and subsequently in the outpatient clinic, as required by clinical practice.\n\nHe/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.\n\nIn 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.\n\nData 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fetuses and Infants born before 32 weeks of gestation, with and without fetal growth restriction\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Need for palliative care\n* Major malformations'}, 'identificationModule': {'nctId': 'NCT06919757', 'acronym': 'ELFIGO', 'briefTitle': 'Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Early Lung Function Trajectories: Comparison Between Infants With Intrauterine Growth Restriction and Appropriately Grown Ones.', 'orgStudyIdInfo': {'id': '6642'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants born preterm with history of IUGR', 'description': 'preterm infants with history of intrauterine growth restriction', 'interventionNames': ['Diagnostic Test: fetal ultrasound to assess lungs, heart and diaphragm']}, {'label': 'Infants born preterm without history of IUGR', 'description': 'preterm infants without history of intrauterine growth restriction', 'interventionNames': ['Diagnostic Test: fetal ultrasound to assess lungs, heart and diaphragm']}], 'interventions': [{'name': 'fetal ultrasound to assess lungs, heart and diaphragm', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['lung function tests'], 'description': '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.', 'armGroupLabels': ['Infants born preterm with history of IUGR', 'Infants born preterm without history of IUGR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Nobile, MD, PhD, MSc', 'role': 'CONTACT', 'email': 'stefano.nobile@policlinicogemelli.it', 'phone': '+390630156937'}], 'facility': 'Fondazione Policlinico Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Stefano Nobile, MD, PhD, MSc', 'role': 'CONTACT', 'email': 'stefano.nobile@policlinicogemelli.it', 'phone': '+390630156937'}], 'overallOfficials': [{'name': 'Stefano Nobile, MD, PhD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}