Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-29 @ 7:47 AM
Study NCT ID:
NCT04525495
Status:
UNKNOWN
Last Update Posted:
2020-08-25
First Post:
2020-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dopamine in Neonate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004298', 'term': 'Dopamine'}], 'ancestors': [{'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-20', 'studyFirstSubmitDate': '2020-07-26', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Steady state concentration of dopamine (Css) at 2mcg/kg/min', 'timeFrame': 'After continuous infusion for more than 30 minutes at 2mcg/kg/min', 'description': 'dopamine drug level in blood'}, {'measure': 'Steady state concentration of dopamine (Css) at 5mcg/kg/min', 'timeFrame': 'After continuous infusion for more than 30 minutes at 5mcg/kg/min', 'description': 'dopamine drug level in blood'}, {'measure': 'Steady state concentration of dopamine (Css) at 10mcg/kg/min', 'timeFrame': 'After continuous infusion for more than 30 minutes at 10mcg/kg/min', 'description': 'dopamine drug level in blood'}, {'measure': 'Steady state concentration of dopamine (Css) at 15mcg/kg/min', 'timeFrame': 'After continuous infusion for more than 30 minutes at 15mcg/kg/min', 'description': 'dopamine drug level in blood'}, {'measure': 'Steady state concentration of dopamine (Css) at 20mcg/kg/min', 'timeFrame': 'After continuous infusion for more than 30 minutes at 20mcg/kg/min', 'description': 'dopamine drug level in blood'}], 'secondaryOutcomes': [{'measure': 'Blood pressure in mmHg at 2mcg/kg/min', 'timeFrame': 'After continuous infusion for more than 30 minutes at 2mcg/kg/min', 'description': 'Systolic, diastolic and mean blood pressure in mmHg'}, {'measure': 'Blood pressure in mmHg at 5mcg/kg/min', 'timeFrame': 'After continuous infusion for more than 30 minutes at 5mcg/kg/min', 'description': 'Systolic, diastolic and mean blood pressure in mmHg'}, {'measure': 'Blood pressure in mmHg at 10mcg/kg/min', 'timeFrame': 'After continuous infusion for more than 30 minutes at 10mcg/kg/min', 'description': 'Systolic, diastolic and mean blood pressure in mmHg'}, {'measure': 'Blood pressure in mmHg at 10mcg/kg/min', 'timeFrame': 'After continuous infusion for more than 30 minutes at 20mcg/kg/min', 'description': 'Systolic, diastolic and mean blood pressure in mmHg'}, {'measure': 'Heart rate', 'timeFrame': 'After continuous infusion for more than 30 minutes at 2mcg/kg/min'}, {'measure': 'Heart rate', 'timeFrame': 'After continuous infusion for more than 30 minutes at 5mcg/kg/min'}, {'measure': 'Heart rate', 'timeFrame': 'After continuous infusion for more than 30 minutes at 10mcg/kg/min'}, {'measure': 'Heart rate', 'timeFrame': 'After continuous infusion for more than 30 minutes at 15mcg/kg/min'}, {'measure': 'Heart rate', 'timeFrame': 'After continuous infusion for more than 30 minutes at 20mcg/kg/min'}, {'measure': 'Ejection fraction from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 2mcg/kg/min'}, {'measure': 'Ejection fraction from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 5mcg/kg/min'}, {'measure': 'Ejection fraction from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 10mcg/kg/min'}, {'measure': 'Ejection fraction from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 15mcg/kg/min'}, {'measure': 'Ejection fraction from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 20mcg/kg/min'}, {'measure': 'Fractional shortening from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 2mcg/kg/min'}, {'measure': 'Fractional shortening from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 5mcg/kg/min'}, {'measure': 'Fractional shortening from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 10mcg/kg/min'}, {'measure': 'Fractional shortening from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 15mcg/kg/min'}, {'measure': 'Fractional shortening from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 20mcg/kg/min'}, {'measure': 'Tei index from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 2mcg/kg/min', 'description': '(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)'}, {'measure': 'Tei index from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 5mcg/kg/min', 'description': '(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)'}, {'measure': 'Tei index from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 10mcg/kg/min', 'description': '(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)'}, {'measure': 'Tei index from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 15mcg/kg/min', 'description': '(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)'}, {'measure': 'Tei index from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 20mcg/kg/min', 'description': '(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)'}, {'measure': 'VTI (velocity time integral) from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 2mcg/kg/min', 'description': 'the area within the spectral curve and indicates how far blood travels during the flow period'}, {'measure': 'VTI (velocity time integral) from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 5mcg/kg/min', 'description': 'the area within the spectral curve and indicates how far blood travels during the flow period'}, {'measure': 'VTI (velocity time integral) from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 10mcg/kg/min', 'description': 'the area within the spectral curve and indicates how far blood travels during the flow period'}, {'measure': 'VTI (velocity time integral) from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 15mcg/kg/min', 'description': 'the area within the spectral curve and indicates how far blood travels during the flow period'}, {'measure': 'VTI (velocity time integral) from Echocardiography', 'timeFrame': 'After continuous infusion for more than 30 minutes at 20mcg/kg/min', 'description': 'the area within the spectral curve and indicates how far blood travels during the flow period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonates and Preterm Infants']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of dopamine which is used as treatment of hypotension in neonate and preterm infant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted at NICU in Seoul National University Hospital, Seoul Asan Hospital or Severance Hospital\n* Infants who were diagnosed with hypotension\n\nExclusion Criteria:\n\n* Congenital heart disease\n* Chromosomal anomaly\n* Treated with ECMO or CRRT\n* Arrhythmia\n* Hypovolemic state'}, 'identificationModule': {'nctId': 'NCT04525495', 'briefTitle': 'Dopamine in Neonate', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Neonates and Preterm Infants', 'orgStudyIdInfo': {'id': 'DPMSNUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dopamine treatment', 'interventionNames': ['Drug: Dopamine']}], 'interventions': [{'name': 'Dopamine', 'type': 'DRUG', 'description': 'Dopamine treatment', 'armGroupLabels': ['Dopamine treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul National University Children's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Han-Suk Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul National University Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}