Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-31 @ 12:49 PM
Study NCT ID:
NCT07133412
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-27
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraph
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude', 'timeFrame': 'First 30 minutes of surgery', 'description': 'Average amplitude of the evoked response of the muscles.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to use electromyography-based train-of-four monitoring (TetraGraph™ Neuromuscular Transmission Monitor) as a means of evaluating differences in neuromuscular transmission between infants ≤ 3 months of age and adolescent and older patients (≥ 12 years of age).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-3 patients\n* Aged 28 days - 3 months or ≥ 12 years\n* Undergoing a surgical procedure with a volatile-agent based anesthetic that does not require administration of a neuromuscular blocking agent\n\nExclusion Criteria:\n\n* Patients with history of a peripheral neurologic or neuropathic disorder\n* Patients in whom the upper extremity cannot be used for TOF monitoring\n* Patients undergoing a surgical procedure in which neuromuscular blockade is required\n* Edematous patients\n* Patients receiving total intravenous anesthesia (TIVA)'}, 'identificationModule': {'nctId': 'NCT07133412', 'briefTitle': 'An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraph', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'An Evaluation of the Neuromuscular Junction in Infants Using Train-of-four Monitoring With the TetraGraph™ Neuromuscular Transmission Monitor', 'orgStudyIdInfo': {'id': 'STUDY00005296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infants', 'description': 'Infants 28 days to 3 months old undergoing surgery.', 'interventionNames': ['Device: TetraGraph']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adolescents', 'description': 'Adolescents/young adults 12 years of age or above undergoing surgery.', 'interventionNames': ['Device: TetraGraph']}], 'interventions': [{'name': 'TetraGraph', 'type': 'DEVICE', 'description': 'TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.', 'armGroupLabels': ['Adolescents', 'Infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Julie Rice-Weimer, RN', 'role': 'CONTACT', 'email': 'Julie.Rice-Weimer@nationwidechildrens.org', 'phone': '614-355-3142'}, {'name': 'Joseph Tobias, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Julie Rice-Weimer, RN', 'role': 'CONTACT', 'email': 'julie.rice-weimer@nationwidechildrens.org', 'phone': '614-355-3142'}, {'name': 'Catherine Roth, MPH', 'role': 'CONTACT', 'email': 'catherine.roth@nationwidechildrens.org', 'phone': '614-722-2997'}], 'overallOfficials': [{'name': 'Joseph D Tobias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph D. Tobias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief - Dept. of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}