Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-04 @ 5:21 AM
Study NCT ID:
NCT02062151
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2014-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009357', 'term': 'Neonatal Abstinence Syndrome'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lweathers@health.usf.edu', 'phone': '813/844-3046', 'title': 'Laura Weathers', 'organization': 'USF Pediatrics'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'NAS Babies', 'description': 'Acupuncture for NAS\n\nAcupuncture', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'MRI with acupuncture needle in place', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Skin Breakdown and / or Cellulitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NAS Babies', 'description': 'Acupuncture for NAS\n\nAcupuncture: Acupuncture'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 57 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Dislodged Needles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'placed needles', 'counts': [{'value': '394', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NAS Babies', 'description': 'Acupuncture for NAS\n\nAcupuncture: Acupuncture'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within three days of placement', 'unitOfMeasure': 'percentage of needles', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'placed needles', 'denomUnitsSelected': 'placed needles'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NAS Babies', 'description': 'Acupuncture for NAS\n\nAcupuncture: Acupuncture'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'NAS Babies', 'description': 'Acupuncture for NAS\n\nAcupuncture: Acupuncture'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'duration of nicu admission', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'duration of methadone treatment', 'classes': [{'categories': [{'measurements': [{'value': '21', 'spread': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-15', 'studyFirstSubmitDate': '2014-02-05', 'resultsFirstSubmitDate': '2016-08-11', 'studyFirstSubmitQcDate': '2014-02-10', 'lastUpdatePostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-23', 'studyFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Skin Breakdown and / or Cellulitis', 'timeFrame': 'up to 57 days'}, {'measure': 'Percentage of Dislodged Needles', 'timeFrame': 'Within three days of placement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acupuncture'], 'conditions': ['Neonatal Abstinence Syndrome']}, 'descriptionModule': {'briefSummary': 'This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants who require pharmacologic therapy. We intend to evaluate acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and methodological issues. We plan to also test and generate hypotheses in preparation to apply for funding a larger randomized controlled trial.', 'detailedDescription': 'Objectives:\n\nPrimary: To establish feasibility of a protocol for auricular acupuncture in infants suffering from NAS admitted to the NICU receiving pharmacologic therapy.\n\nSecondary: In infants suffering from NAS admitted to the Neonatal Intensive Care Unit (NICU) receiving pharmacologic therapy:\n\n1. Determine parent and staff acceptability of auricular acupuncture\n2. Determine infant tolerance to auricular acupuncture\n3. Evaluate the effect of auricular acupuncture on individual items of the Modified Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system responses\n4. Evaluate the effect of auricular acupuncture on time to return to birth weight'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate\n2. Admitted to NICU with diagnosis of NAS requiring pharmacologic therapy\n3. Parents give written consent within 72 hours of infant receiving first dose of methadone\n\nExclusion Criteria:\n\n1. Helix or antihelix of ear is deformed and needle is unable to be placed\n2. A suspected or confirmed genetic or metabolic syndrome\n3. Custody retained by the Department of Children and Families\n4. Any skin condition involving the ear(s)\n5. Suspected or documented infection at the time of enrollment'}, 'identificationModule': {'nctId': 'NCT02062151', 'acronym': 'AA NAS', 'briefTitle': 'Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Acupuncture Use in Infants Treated for Neonatal Abstinence Syndrome: a Pilot Study', 'orgStudyIdInfo': {'id': 'Acupuncture for NAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAS babies', 'description': 'Acupuncture for NAS', 'interventionNames': ['Other: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'Acupuncture', 'armGroupLabels': ['NAS babies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Laura Weathers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}