Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-05 @ 10:31 AM
Study NCT ID:
NCT04621734
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2020-11-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D053832', 'term': 'Surgical Tape'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mirelesv@uthscsa.edu', 'phone': '210-274-8969', 'title': 'Dr. Veronica Armijo-Garcia', 'organization': 'University of Texas Health Science Center at San Antonio'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Nasal Bridle to Secure Feeding Tube', 'description': 'The nasal bridle will be used to secure the nasoenteric feeding tube.\n\nAMT BridlePro Device: A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 1, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Adhesive Tape Use to Secure Feeding Tube', 'description': 'Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.\n\nAdhesive Tape: Adhesive tape used to secure nasoenteric tube', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin Breakdown', 'notes': 'Skin breakdown at the site of the bridle or adhesive tape', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Tube Dislodgements Per 10 Tube Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nasal Bridle to Secure Feeding Tube', 'description': 'The nasal bridle will be used to secure the nasoenteric feeding tube.\n\nAMT BridlePro Device: A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.'}, {'id': 'OG001', 'title': 'Adhesive Tape Use to Secure Feeding Tube', 'description': 'Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.\n\nAdhesive Tape: Adhesive tape used to secure nasoenteric tube'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.11', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'The number of times the tube is dislodged for every 10 days of feeding tubes.', 'unitOfMeasure': 'Dislodgements', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nasal Bridle to Secure Feeding Tube', 'description': 'The nasal bridle will be used to secure the nasoenteric feeding tube.\n\nAMT BridlePro Device: A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.'}, {'id': 'FG001', 'title': 'Adhesive Tape Use to Secure Feeding Tube', 'description': 'Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.\n\nAdhesive Tape: Adhesive tape used to secure nasoenteric tube'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nasal Bridle to Secure Feeding Tube', 'description': 'The nasal bridle will be used to secure the nasoenteric feeding tube.\n\nAMT BridlePro Device: A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.'}, {'id': 'BG001', 'title': 'Adhesive Tape Use to Secure Feeding Tube', 'description': 'Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.\n\nAdhesive Tape: Adhesive tape used to secure nasoenteric tube'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'BG000', 'lowerLimit': '0.1', 'upperLimit': '17.1'}, {'value': '9.1', 'groupId': 'BG001', 'lowerLimit': '0.1', 'upperLimit': '17.7'}, {'value': '7.8', 'groupId': 'BG002', 'lowerLimit': '0.1', 'upperLimit': '17.7'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-09', 'size': 466972, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-25T13:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-07', 'studyFirstSubmitDate': '2020-11-03', 'resultsFirstSubmitDate': '2023-01-08', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-07', 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Tube Dislodgements Per 10 Tube Days.', 'timeFrame': '10 days', 'description': 'The number of times the tube is dislodged for every 10 days of feeding tubes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Feeding Tube Complication']}, 'referencesModule': {'references': [{'pmid': '40369642', 'type': 'DERIVED', 'citation': 'Foster M, Armijo-Garcia V, Gelfond J, Meyer AD. Improving retention of pediatric feeding tubes with a nasal bridle: a randomized controlled trial. Trials. 2025 May 14;26(1):159. doi: 10.1186/s13063-025-08867-x.'}]}, 'descriptionModule': {'briefSummary': 'A study to compare tube dislodgment rates when a nasoenteric feeding tube is secured with adhesive tape vs the AMT BridlePro device.', 'detailedDescription': 'The adhesive tape will be the tape available in the unit and will be placed by the nurse or provider at the time of nasoenteric tube placement. The tape will be placed around the tube and secured to the cheek on the side of tube. The tape will be replaced as needed per nursing discretion when soiled or the adhesive properties are failing and this information will be tracked. The AMT BridlePro will be placed by the nurse or provider at the time of nasoenteric tube placement. Placement will use the BridlePro system included in the individual BridlePro packaging. Placement and securement will follow manufacturer recommendations and teaching. The BridlePro encircles the vomer bone of the nasal cavity to secure the tube. Sedation medication may be given per standard of care for nasoenteric tube placement at the discretion of the provider team but no separate or additional sedation medication will be given for securement with adhesive tape or the BridlePro.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need for nasoenteric feeding\n* Admitted to University Hospital\n* Age 0-18 years\n\nExclusion Criteria:\n\n* Facial trauma\n* Nasal airway obstructions\n* Thrombocytopenia (\\<100 K/μL)\n* s/p septoplasty\n* Patients with vomer bone graft\n* Nasoenteric feeding tube placed and secured prior to being screened for study\n* Contraindication for the use of the BridlePro\n* Does not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04621734', 'briefTitle': 'Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Improving Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle', 'orgStudyIdInfo': {'id': 'HSC20190225H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nasal bridle to secure feeding tube', 'description': 'The nasal bridle will be used to secure the nasoenteric feeding tube.', 'interventionNames': ['Device: AMT BridlePro Device']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Adhesive Tape use to secure feeding tube', 'description': 'Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.', 'interventionNames': ['Device: Adhesive Tape']}], 'interventions': [{'name': 'AMT BridlePro Device', 'type': 'DEVICE', 'otherNames': ['Applied Medical Technology (AMT) BridlePro Device'], 'description': 'A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.', 'armGroupLabels': ['Nasal bridle to secure feeding tube']}, {'name': 'Adhesive Tape', 'type': 'DEVICE', 'otherNames': ['Tape'], 'description': 'Adhesive tape used to secure nasoenteric tube', 'armGroupLabels': ['Adhesive Tape use to secure feeding tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University Health System', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Veronica Armijo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Health at San Antonio'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}