Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-11 @ 8:41 PM
Study NCT ID:
NCT04114435
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2019-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart function by echocardiography', 'timeFrame': '7-10 days of chronological age', 'description': 'STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance'}, {'measure': 'Heart function by echocardiography', 'timeFrame': '35-37 weeks post-menstrual age', 'description': 'STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance'}, {'measure': 'Heart function by echocardiography', 'timeFrame': '39-44 weeks PMA', 'description': 'STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance'}, {'measure': 'Heart function by echocardiography', 'timeFrame': '4 months PMA', 'description': 'STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance'}, {'measure': 'Heart function by echocardiography', 'timeFrame': '9 months PMA', 'description': 'STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance'}, {'measure': 'Heart function by echocardiography', 'timeFrame': '36 months PMA', 'description': 'STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance'}, {'measure': 'Heart function by echocardiography', 'timeFrame': '5 years chronological', 'description': 'STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance'}], 'secondaryOutcomes': [{'measure': 'Neuro-developmental profile', 'timeFrame': '7-10 days of chronological age', 'description': 'Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography'}, {'measure': 'Neuro-developmental profile', 'timeFrame': '35-37 weeks post-menstrual age', 'description': 'Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography'}, {'measure': 'Neuro-developmental profile', 'timeFrame': '39-44 weeks PMA', 'description': 'Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography'}, {'measure': 'Neuro-developmental profile', 'timeFrame': '4 months PMA', 'description': 'Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography'}, {'measure': 'Neuro-developmental profile', 'timeFrame': '9 months PMA', 'description': 'Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography'}, {'measure': 'Neuro-developmental profile', 'timeFrame': '36 months PMA', 'description': 'Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography'}, {'measure': 'Neuro-developmental profile', 'timeFrame': '5 years chronological', 'description': 'Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prematurity; Extreme']}, 'descriptionModule': {'briefSummary': 'Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study', 'detailedDescription': 'The principal investigator hypothesize that premature newborns have disturbed cardiac performance and increased pulmonary pressures during neonatal life and at different pediatric ages.\n\nThe principal investigator also hypothesize that premature newborns with poor cardiac performance and/or pulmonary hypertension have higher morbidities and poorer neuro-developmental outcomes.\n\nThe principal investigator also hypothesize that premature newborns with poor cardiac performance and/or pulmonary hypertension have higher morbidities and poorer neuro-developmental outcomes and that novel echocardiography techniques will detect anomalies not uncovered by conventional imaging, and that early echocardiography may identify those with later pulmonary hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '7 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Extreme premature newborns (\\<29 weeks)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infants born at \\<29 weeks' gestational age admitted to the NICU\n* All infants born at \\<29 weeks' gestational age followed at MCH clinic after an admission in the NICU for prematurity \\<29 weeks\n\nExclusion Criteria:\n\n* Congenital heart disease (except an atrial (ASD) or ventricular septal defect (VSD), or a patent ductus arteriosus (PDA))\n* Congenital severe lung or airway malformation (choanal atresia, trachea-esophageal fistula or congenital pulmonary airway malformation)\n* Genetic disorder (Trisomy 21)."}, 'identificationModule': {'nctId': 'NCT04114435', 'briefTitle': 'Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants: A Prospective Cross-sectional Study', 'orgStudyIdInfo': {'id': '2020-5893'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neonatal profile', 'description': 'Echocardiography at:\n\n* 7 to 10 days of chronological age\n* 35 to 37 weeks post-menstrual age (PMA = corrected age);\n* 39 to 44 weeks PMA; Term equivalent', 'interventionNames': ['Other: Echocardiography']}, {'label': 'Infant profile ( between 4 months and 9 months)', 'description': '* Echocardiography\n* Ages \\& stages questionnaires CAT/CLAMS assessment', 'interventionNames': ['Other: Echocardiography']}, {'label': 'Pediatric profile (36 months and 5 years)', 'description': '* Echocardiography\n* Ages \\& stages questionnaires CAT/CLAMS assessment\n* Results from 18 months PMA Bayley will be retrieved Figure 1: Premature population - Groups Recruited simultaneously', 'interventionNames': ['Other: Echocardiography']}], 'interventions': [{'name': 'Echocardiography', 'type': 'OTHER', 'description': 'Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures', 'armGroupLabels': ['Infant profile ( between 4 months and 9 months)', 'Neonatal profile', 'Pediatric profile (36 months and 5 years)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Gabriel Altit, MD', 'role': 'CONTACT', 'email': 'gabriel.altit@mail.mcgill.ca', 'phone': '514-412-4452'}], 'facility': 'Mcgill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neonatologist', 'investigatorFullName': 'Gabriel Altit', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}