Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-20 @ 12:29 PM
Study NCT ID:
NCT01910467
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2013-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avoiding Hypotension in Preterm Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-16', 'studyFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2013-07-25', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Neonatal morbidities', 'timeFrame': 'up to 16 weeks', 'description': 'From date of randomization until the date of discharge or date of 40 weeks of gestational age, whichever came first, assessed up to 16 weeks.'}, {'measure': 'Heart rate', 'timeFrame': '48 hours'}, {'measure': 'Blood pressure', 'timeFrame': '48 hours'}, {'measure': 'Arterial oxygen saturation', 'timeFrame': '48 hours'}], 'primaryOutcomes': [{'measure': 'Time (percentage of hours) of hypotension/use of catecholamines during the first 48 hours', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Cerebral injury by cerebral ultrasound', 'timeFrame': 'up to 16 weeks', 'description': 'From date of randomization until the date of discharge or date of 40 weeks of gestational age, whichever came first, assessed up to 16 weeks.'}, {'measure': 'Mortality', 'timeFrame': 'up to 16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypotension']}, 'referencesModule': {'references': [{'pmid': '32692715', 'type': 'DERIVED', 'citation': 'Hoeller N, Baik-Schneditz N, Schwaberger B, Mileder L, Urlesberger B, Pichler G. Cerebral and peripheral muscle oxygenation and perfusion: Course in moderate and late preterm neonates during the first day after birth. Physiol Int. 2020 Jul 17;107(2):267-279. doi: 10.1556/2060.2020.00028.'}, {'pmid': '29450194', 'type': 'DERIVED', 'citation': 'Pichler G, Holler N, Baik-Schneditz N, Schwaberger B, Mileder L, Stadler J, Avian A, Pansy J, Urlesberger B. Avoiding Arterial Hypotension in Preterm Neonates (AHIP)-A Single Center Randomised Controlled Study Investigating Simultaneous Near Infrared Spectroscopy Measurements of Cerebral and Peripheral Regional Tissue Oxygenation and Dedicated Interventions. Front Pediatr. 2018 Feb 1;6:15. doi: 10.3389/fped.2018.00015. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Objectives Firstly to examine in preterm neonates, whether it is possible to reduce number of hypotensive episodes and use of catecholamines by applying cerebral/peripheral near infrared spectroscopy in combination with predefined interventions and secondly to explore the potential impact on cerebral injury and mortality.\n\nHypothesis By using predefined interventions for changes in cerebral/peripheral oxygenation ratio investigators will reduce hypotensive episodes and use of catecholamines which will reduce cerebral injury and mortality.\n\nMethods Cerebral (cTOI) and peripheral-muscle (pTOI) tissue-oxygenation-index (NIRO 300) will be measured for 24h starting \\<6 hours postpartum. When cTOI/pTOI ratio increases \\>5% within a 6h period, predefined interventions will be performed.\n\nPrimary outcome parameter will be duration of hypotensive episodes and use of catecholamines during the first 48h after birth. Secondary outcome parameters will be cerebral injury and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm neonates\n* decision to conduct full life support\n* written informed consent\n* age \\<6 hours\n* no use of catecholamines before start of NIRS measurements\n\nExclusion Criteria:\n\n* no decision to conduct full life support\n* no written informed consent\n* age \\>6 hours\n* use of catecholamines before start of NIRS measurements\n* congenital malformation'}, 'identificationModule': {'nctId': 'NCT01910467', 'acronym': 'AHIP', 'briefTitle': 'Avoiding Hypotension in Preterm Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Avoiding Hypotension in Preterm Neonates (AHIP) - A Randomised Controlled Study on Near Infrared Spectroscopy Monitoring of Peripheral-muscle and Cerebral Oxygenation With Defined Interventions Versus Routine Monitoring and Treatment in Preterm Neonates', 'orgStudyIdInfo': {'id': '15351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIRS visible and predefined interventions', 'description': 'NIRS measurements are visible and the patients will be treated according to predefined clinical interventions: If cTOI/pTOI ratio increases \\>5% within a six-hours-period echocardiography will be performed and based on results of echocardiography and blood pressure a volume bolus or, if ventilated, modification of ventilation or treatment of patent ductus arteriosus will be considered.', 'interventionNames': ['Device: NIRS visible and predefined interventions']}, {'type': 'OTHER', 'label': 'NIRS not visible and treatment as usual', 'description': "NIRS measurements are not visible and the patients will be treated according to routine ('treatment as usual')", 'interventionNames': ['Device: NIRS not visible and treatment as usual']}], 'interventions': [{'name': 'NIRS visible and predefined interventions', 'type': 'DEVICE', 'description': 'NIRS measurements are visible and the patients will be treated according to predefined clinical interventions: If cTOI/pTOI ratio increases \\>5% within a six-hours-period echocardiography will be performed and based on results of echocardiography and blood pressure a volume bolus or, if ventilated, modification of ventilation or treatment of patent ductus arteriosus will be considered.', 'armGroupLabels': ['NIRS visible and predefined interventions']}, {'name': 'NIRS not visible and treatment as usual', 'type': 'DEVICE', 'description': 'NIRS not visible and the patients will be treated according to routine', 'armGroupLabels': ['NIRS not visible and treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Dep. of Pediatrics, Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Gerhard Pichler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep. of Pediatrics, Medical University of Graz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Prof. Dr.', 'investigatorFullName': 'Pichler Gerhard, MD.', 'investigatorAffiliation': 'Medical University of Graz'}}}}