Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT04644094
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2020-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postnatal Steroids Effects on Cardiac Function in Extremely Preterm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}, {'id': 'D004374', 'term': 'Ductus Arteriosus, Patent'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores)', 'timeFrame': 'At the time of echocardiography', 'description': 'The effects of dexamethasone administration on cardiac structure/performance will be evaluated by using the M-mode technique (Devereux method (25-27)\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}, {'measure': 'Lung water content', 'timeFrame': 'At the time of echocardiography', 'description': 'Lung water content will be specifically determined by the degree of water retention in premature lungs assessed by lung ultrasound at the specified time points:\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}], 'secondaryOutcomes': [{'measure': 'Left ventricular (LV) output', 'timeFrame': 'At the time of echocardiography', 'description': 'The effects of dexamethasone administration on:\n\nOn the LV output assessed by Doppler by echocardiography\n\nTime points:\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}, {'measure': 'LV and RV function by strain', 'timeFrame': 'At the time of echocardiography', 'description': 'LV and RV function by strain by post treatment of echocardiography acquired images with a Tomtec platform\n\nTime points:\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}, {'measure': 'LV ejection fraction', 'timeFrame': 'At the time of echocardiography', 'description': 'The effects of dexamethasone administration on:\n\nThe ejection fraction measured by Simpson on a echocardiography.\n\nTime points:\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}, {'measure': 'Ductal size', 'timeFrame': 'At the time of echocardiography', 'description': 'The effects of dexamethasone administration on the size patent ductus arteriosus (PDA) measured on the echocardiography\n\nTime points:\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}, {'measure': 'Doppler flow velocities', 'timeFrame': 'At the time of echocardiography', 'description': 'The effects of dexamethasone administration on:\n\nThe Doppler flow velocities measured by echocardiography\n\nTime points:\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}, {'measure': 'Measures of PDA significance', 'timeFrame': 'At the time of echocardiography', 'description': 'The effects of dexamethasone administration on:\n\nLA:AO (left atrium: aorta) Resistance index (RI) of the Anterior Cerebral Artery Direction of ductal flow Peak velocity of PDA in systole\n\nTime points:\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}, {'measure': 'LV mass by STE', 'timeFrame': 'At the time of echocardiography', 'description': 'LV mass calculation using Speckle tracking echocardiography (STE) on the Tomtec platform\n\nTime points:\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}, {'measure': 'RV function by TAPSE', 'timeFrame': 'At the time of echocardiography', 'description': 'The effects of dexamethasone administration on:\n\nTricuspid annular plane systolic excursion measurement by M-Mode on the echocardiography\n\nTime points:\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}, {'measure': 'Strain and 3D values', 'timeFrame': 'At the time of echocardiography', 'description': 'The effects of dexamethasone administration on:\n\nRV and LV strains and on the cardiac volumes by 3 D (RV and LV) by echocardiography acquired images, using Tomtec platform for post treatment\n\nTime points:\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}, {'measure': 'Heart rate variability', 'timeFrame': 'At the time of echocardiography', 'description': 'The effects of dexamethasone administration on heart rate variability by ECG\n\nTime points:\n\n0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer'}, {'measure': 'Growth trajectory', 'timeFrame': 'At the time of the last echocardiography', 'description': 'The effects of dexamethasone administration on growth trajectory (body, length, head circumference, L/W ratio) at 1-,2-weekks prior treatment and 1-,2-,3-,4-,6-,8- weeks after treatment, and finally at 36 weeks PMA'}, {'measure': 'Cortisol levels', 'timeFrame': 'At the study completion (12 months)', 'description': 'The effects of dexamethasone after administration:\n\nCortisol levels in nmol/L'}, {'measure': 'BPD', 'timeFrame': 'At the study completion (12 months)', 'description': 'The effects of dexamethasone administration on:\n\n-BPD rate (%) (2018 NICHD definition)'}, {'measure': 'Mortality', 'timeFrame': 'At the study completion (12 months)', 'description': '\\- Rate of death in this high risk population (%)'}, {'measure': 'Responders and non responders to Dexamethasone', 'timeFrame': 'At the study completion (12 months)', 'description': 'We will analyze the rate (%) of responders and non-responders to Dexamethasone. Responders: Defined by decreasing Respiratory Severity Scores (RSS) by 40% at day 6 of Dexamethasone treatment or before. RSS is calculated by using maximum of mean airway pressure (MAP) multiplied by fractional oxygen (FiO2) at the day of the first dose of Dexamethasone administration (Day 0)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung ultrasound', 'Echocardiography', 'Heart rate variability', 'Left ventricular hypertrophy', 'Ductus arteriosus', 'Dexamethasone'], 'conditions': ['Left Ventricular Hypertrophy']}, 'descriptionModule': {'briefSummary': 'Hypothesis/Study question\n\nIn infants born at less than 29 weeks of estimated gestational age, what are the effects of dexamethasone use on cardiac structure/performance and lung water content?\n\nStudy objectives\n\nTo measure effects before and after dexamethasone administration on cardiac structure/performance will be evaluated by using the M-mode technique (Devereux method (25-27) and lung water content will be specifically determined by the degree of water retention in premature lungs assessed by lung ultrasound at the pre specified time points.\n\nMethodology / Study design\n\nSingle center, prospective observational cohort study planning to enroll eligible patients over a period of 12 months', 'detailedDescription': 'This study investigates the effects of dexamethasone on cardiac structure/performance and lung water content in the extremely preterm population undergoing treatment for significant lung disease. For that, the specific aims are to determine the occurrence, evolution over time and possible hemodynamic impact of left ventricular hypertrophy and occurrence and degree of water retention in premature lungs, after dexamethasone administration. As secondary outcomes, this study also investigates the effects of dexamethasone on the ductus arteriosus, body growth, and autonomic regulation heart rate variability, as well as other important outcomes outlined in this protocol.\n\nThis study hypothesize that in some infants dexamethasone will be associated with the occurrence of early and/or prolonged left ventricular hypertrophy, which may be associated with changes in cardiac performance. It also hypothesize that the anti-inflammatory effects of dexamethasone would improve inflammation of immature lungs, leading to a decrease in interstitial fluid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Extreme premature babies (\\< 29 weeks of gestational age at birth) undergoing first treatment with dexamethasone for significant lung disease at the neonatal intensive care.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\< 29 weeks of gestational age at birth admitted at the McGill University Children Hospital's neonatal intensive care unit\n* To be initiated on dexamethasone therapy for treatment of significant lung disease as per medical team decision.\n\nExclusion Criteria:\n\n* Congenital heart disease (except: Atrial septum defect (ASD), Ventricular septum defect (VSD)\n* Major congenital anomalies/genetic disorder (Trisomy 13, 18, 21)\n* Congenital severe lung or airway malformation (Trachea-esophageal fistula, congenital pulmonary airway malformation, congenital diaphragmatic hernia)\n* Twin-twin transfusion syndrome"}, 'identificationModule': {'nctId': 'NCT04644094', 'acronym': 'SPEC', 'briefTitle': 'Postnatal Steroids Effects on Cardiac Function in Extremely Preterm', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': '"Surveillance of Postnatal Steroids Effects on Cardiac Function in Extremely Preterm Infants With Evolving BPD: the SPEC Study."', 'orgStudyIdInfo': {'id': '2021-7305'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administration', 'type': 'OTHER', 'description': 'A. Electrocardiographic (ECG) leads will be place in the patient for electrocardiogram (ECG) recordings.\n\nB. Echocardiography (ECHO) will be performed by an expert member of the Neonatal Echocardiography team C. Heart Rate Variability (HRV): ECG recordings D. Growth trajectory: body weight, length, head circumference, length/weight ratio at 1-, 2-weeks prior treatment, 1-, 2-, 3-, 4-,6-,8-weeks after treatment, at 36-week PMA.'}]}, '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': "Montreal Children's hospital, Mcgill University Health Centre", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Gabriel Altit', 'role': 'CONTACT', 'email': 'gabriel.altit@mcgill.ca', 'phone': '5144124453'}, {'name': 'Jessica Simoneau', 'role': 'CONTACT', 'email': 'jessica.simoneau@muhc.mcgill.ca', 'phone': '5144124453'}], 'overallOfficials': [{'name': 'Gabriel Altit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Montreal Children's hospital, MUHC"}]}, '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'}}}}