Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT05986032
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-09-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-08-09', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Respiratory support mode', 'timeFrame': '7 postnatal days', 'description': 'Respiratory support mode will be coded as 0 = no respiratory support, 1 = nasal high flow therapy, 2 = nasal CPAP or nasal IPPV, 3 = invasive mechanical ventilation'}, {'measure': 'Fraction of inspired oxygen', 'timeFrame': '7 days of life'}], 'primaryOutcomes': [{'measure': 'Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure', 'timeFrame': 'Xrs will be measured at 7 days of life', 'description': 'Xrs will be expressed in z-score using reference equation for very preterm infants'}], 'secondaryOutcomes': [{'measure': 'Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O', 'timeFrame': 'Xrs will be measured at 7 days of life', 'description': 'Xrs will be expressed in cmH2O\\*S/L'}]}, 'conditionsModule': {'keywords': ['Respiratory oscillometry', 'Respiratory system reactance', 'Lung mechanics', 'Infant lung function testing'], 'conditions': ['Bronchopulmonary Dysplasia']}, 'referencesModule': {'references': [{'pmid': '31108499', 'type': 'BACKGROUND', 'citation': 'Zannin E, Neumann RP, Dellaca R, Schulzke SM. Forced oscillation measurements in the first week of life and pulmonary outcome in very preterm infants on noninvasive respiratory support. Pediatr Res. 2019 Sep;86(3):382-388. doi: 10.1038/s41390-019-0432-6. Epub 2019 May 20.'}, {'pmid': '30127523', 'type': 'BACKGROUND', 'citation': "Veneroni C, Wallstrom L, Sindelar R, Dellaca' RL. Oscillatory respiratory mechanics on the first day of life improves prediction of respiratory outcomes in extremely preterm newborns. Pediatr Res. 2019 Feb;85(3):312-317. doi: 10.1038/s41390-018-0133-6. Epub 2018 Aug 4."}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the correlation between respiratory system reactance, as assessed by respiratory oscillometry, and respiratory outcomes in preterm infants born before 32 weeks of gestation. The main question it aims to answer is if the reactance z-score at 7 postnatal days adds to relevant clinical factors in the prediction of bronchopulmonary dysplasia. Participants will receive respiratory oscillometry measurements at 7 ± 2 postnatal days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Days', 'minimumAge': '5 Days', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Infants will be recruited from those admitted to tertiary-level neonatal intensive care units.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* born before 32 weeks post-menstrual age\n\nExclusion Criteria:\n\n* congenital abnormalities\n* Inherited disorders of metabolism'}, 'identificationModule': {'nctId': 'NCT05986032', 'acronym': 'REACT', 'briefTitle': 'Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS San Gerardo dei Tintori'}, 'officialTitle': 'Relationship Between Respiratory System Reactance Assessed by Respiratory Oscillometry and Respiratory Outcomes in Very Preterm Infants', 'orgStudyIdInfo': {'id': 'REACT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'no bronchopulmonary dysplasia', 'description': 'Group of patients who do not receive the diagnosis of bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-mentrual age', 'interventionNames': ['Diagnostic Test: Respiratory Oscillometry']}, {'label': 'bronchopulmonary dysplasia', 'description': 'Group of patients developing bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-menstrual age.', 'interventionNames': ['Diagnostic Test: Respiratory Oscillometry']}], 'interventions': [{'name': 'Respiratory Oscillometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of respiratory system reactance by respiratory oscillometry', 'armGroupLabels': ['bronchopulmonary dysplasia', 'no bronchopulmonary dysplasia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '20900', 'city': 'Monza', 'state': 'Monza E Brianza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Camilla Rigotti, PhD', 'role': 'CONTACT', 'email': 'dr.camilla.rigotti@gmail.com', 'phone': '+39039233', 'phoneExt': '9173'}], 'facility': 'Fondazione IRCCS San Gerardo dei Tintori', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '20122', 'city': 'Milan', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Italy', 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Amsterdam', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Netherlands', 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': 'S-751 85', 'city': 'Uppsala', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Sweden', 'facility': "Uppsala University Children's Hospital", 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': '4056', 'city': 'Basel', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Switzerland', 'facility': 'Universitäts-Kinderspital beider Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Camilla Rigotti, PhD', 'role': 'CONTACT', 'email': 'dr.camilla.rigotti@gmail.com', 'phone': '+39039233', 'phoneExt': '9173'}, {'name': 'Emanuela Zannin, PhD', 'role': 'CONTACT', 'email': 'emanuela.zannin@gmail.com', 'phone': '+393389323437'}], 'overallOfficials': [{'name': 'Camilla Rigotti, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS San Gerardo dei Tintori'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS San Gerardo dei Tintori', 'class': 'OTHER'}, 'collaborators': [{'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, {'name': "University Children's Hospital Basel", 'class': 'OTHER'}, {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': 'Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}