Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-03 @ 8:30 PM
Study NCT ID:
NCT05961657
Status:
UNKNOWN
Last Update Posted:
2023-07-27
First Post:
2023-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
USCOM Parameters in Preterm Infants: Reference Ranges
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-07-18', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Output at 3 days', 'timeFrame': '3 ± 1 days of life', 'description': 'Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min'}, {'measure': 'Cardiac Output at 7 days', 'timeFrame': '7 ± 2 days of life', 'description': 'Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min'}, {'measure': 'Cardiac Output at 14 days', 'timeFrame': '14 ± 2 days of life', 'description': 'Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min'}, {'measure': 'Cardiac Index at 3 days', 'timeFrame': '3 ± 1 days of life', 'description': 'Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2'}, {'measure': 'Cardiac Index at 7 days', 'timeFrame': '7 ± 2 days of life', 'description': 'Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2'}, {'measure': 'Cardiac Index at 14 days', 'timeFrame': '14 ± 2 days of life', 'description': 'Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2'}, {'measure': 'Systemic Vascular Resistance Index at 3 days', 'timeFrame': '3 ± 1 days of life', 'description': 'Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d\\*s\\*cm-5/m2'}, {'measure': 'Systemic Vascular Resistance Index at 7 days', 'timeFrame': '7 ± 2 days of life', 'description': 'Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d\\*s\\*cm-5/m2'}, {'measure': 'Systemic Vascular Resistance Index at 14 days', 'timeFrame': '14 ± 2 days of life', 'description': 'Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d\\*s\\*cm-5/m2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Very Low Birth Weight Infant', 'Very Preterm Maturity of Infant']}, 'referencesModule': {'references': [{'pmid': '32758264', 'type': 'BACKGROUND', 'citation': 'Doni D, Nucera S, Rigotti C, Arosio E, Cavalleri V, Ronconi M, Ventura ML, Fedeli T. Evaluation of hemodynamics in healthy term neonates using ultrasonic cardiac output monitor. Ital J Pediatr. 2020 Aug 5;46(1):112. doi: 10.1186/s13052-020-00872-x.'}, {'pmid': '20605971', 'type': 'BACKGROUND', 'citation': 'Patel N, Dodsworth M, Mills JF. Cardiac output measurement in newborn infants using the ultrasonic cardiac output monitor: an assessment of agreement with conventional echocardiography, repeatability and new user experience. Arch Dis Child Fetal Neonatal Ed. 2011 May;96(3):F206-11. doi: 10.1136/adc.2009.170704. Epub 2010 Jul 6.'}, {'pmid': '31326967', 'type': 'BACKGROUND', 'citation': 'Fraga MV, Dysart KC, Rintoul N, Chaudhary AS, Ratcliffe SJ, Fedec A, Kren S, Cohen MS, Kirpalani H. Cardiac Output Measurement Using the Ultrasonic Cardiac Output Monitor: A Validation Study in Newborn Infants. Neonatology. 2019;116(3):260-268. doi: 10.1159/000501005. Epub 2019 Jul 19.'}, {'pmid': '21933558', 'type': 'BACKGROUND', 'citation': 'He SR, Zhang C, Liu YM, Sun YX, Zhuang J, Chen JM, Madigan VM, Smith BE, Sun X. Accuracy of the ultrasonic cardiac output monitor in healthy term neonates during postnatal circulatory adaptation. Chin Med J (Engl). 2011 Aug;124(15):2284-9.'}]}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants. The main questions it aims to answer are: 1) establishing reference ranges for USCOM parameters in this specific population, 2) assessing the effect of patients' characteristics and other possible confounders on USCOM parameters, and 3) evaluating the short-term repeatability of the measurement. Participants will receive USCOM measurements on 3, 7, and 14 postnatal days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Days', 'minimumAge': '2 Days', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We include very preterm and/or very low birth weight infants without heart disease as assessed by echocardiography, who are considered hemodynamically stable by the attending physician and do not require drugs that might affect the cardiocirculatory function (e.g., inotropes).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age at birth below 32 weeks and/or\n* birth weight (BW) below 1500 g\n\nExclusion Criteria:\n\n* congenital heart diseases,\n* hemodynamic instability requiring drugs that affect hemodynamics (e.g., inotropes)'}, 'identificationModule': {'nctId': 'NCT05961657', 'briefTitle': 'USCOM Parameters in Preterm Infants: Reference Ranges', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS San Gerardo dei Tintori'}, 'officialTitle': 'Hemodynamic Evaluation in Preterm Babies Using UltraSonic Cardiac Output Monitor (USCOM)', 'orgStudyIdInfo': {'id': 'EmoNeo'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hemodynamic measurements by USCOM', 'type': 'DIAGNOSTIC_TEST', 'description': 'We will measure cardiac output, cardiac index, and systemic vascular resistance index on 3, 7, and 14 postnatal days using the UltraSonic Cardiac Output Monitor.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20900', 'city': 'Monza', 'state': 'Monza E Brianza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Danial Donu, MD', 'role': 'CONTACT', 'email': 'danieladoni9@gmail.com', 'phone': '+39039233', 'phoneExt': '9173'}, {'name': 'Emanuela Zannin, PhD', 'role': 'CONTACT', 'email': 'emanuela.zannin@gmail.com'}], 'facility': 'Fondazione IRCCS San Gerardo dei Tintori', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}], 'centralContacts': [{'name': 'Daniela Doni, MD', 'role': 'CONTACT', 'email': 'danieladoni9@gmail.com', 'phone': '+39039233', 'phoneExt': '9173'}, {'name': 'Emanuela Zannin, PhD', 'role': 'CONTACT', 'email': 'emanuela.zannin@gmail.com'}], 'overallOfficials': [{'name': 'Daniela Doni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS San Gerardo dei Tintori'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS San Gerardo dei Tintori', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Neonatologist', 'investigatorFullName': 'Daniela Doni', 'investigatorAffiliation': 'Fondazione IRCCS San Gerardo dei Tintori'}}}}