Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-03 @ 9:44 AM
Study NCT ID:
NCT03113656
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Weighted Blankets With Infants With NAS
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Rachel_Baker2@trihealth.com', 'phone': '513-569-6191', 'title': 'Nurse Researcher', 'organization': 'TriHealth'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During entire hospitalization (ranged from 1 day to 15 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Weighted Blanket: Weighted blanket placed on infant for 30 minutes', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Non-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Finnegan Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Weighted Blanket: Weighted blanket placed on infant for 30 minutes'}, {'id': 'OG001', 'title': 'Control', 'description': 'Non-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5167', 'spread': '2.251', 'groupId': 'OG000'}, {'value': '-0.2549', 'spread': '1.787', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 30 minutes', 'description': 'Finnegan scale measures signs of neonatal drug withdrawal syndrome. It provides a summative score obtained from the assessment of 21 items related to neonatal withdrawal. The total score ranges from 0 to 43 with a higher score indicating more severe symptoms. Values above 8 have been described as being indicative of neonatal abstinence syndrome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting Arms/Groups "per intervention"'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Weighted Blanket First', 'description': 'This group will receive the Weighted Blanket first and then the Non-weighted blanket\n\nWeighted Blanket: Weighted blanket placed on infant for 30 minutes\n\nNon-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes'}, {'id': 'FG001', 'title': 'Non-weighted Blanket First', 'description': 'This group will receive the Non-weighted Blanket first and then the Weighted blanket\n\nWeighted Blanket: Weighted blanket placed on infant for 30 minutes\n\nNon-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Weighted Blanket First', 'description': 'This group will receive the Weighted Blanket first and then the Non-weighted blanket\n\nWeighted Blanket: Weighted blanket placed on infant for 30 minutes\n\nNon-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes'}, {'id': 'BG001', 'title': 'Non-weighted Blanket First', 'description': 'This group will receive the Non-weighted Blanket first and then the Weighted blanket\n\nWeighted Blanket: Weighted blanket placed on infant for 30 minutes\n\nNon-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.89', 'spread': '8.24', 'groupId': 'BG000'}, {'value': '4.00', 'spread': '3.06', 'groupId': 'BG001'}, {'value': '5.63', 'spread': '6.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-25', 'size': 294640, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-12T13:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2017-04-10', 'resultsFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-14', 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Finnegan Score', 'timeFrame': 'baseline and 30 minutes', 'description': 'Finnegan scale measures signs of neonatal drug withdrawal syndrome. It provides a summative score obtained from the assessment of 21 items related to neonatal withdrawal. The total score ranges from 0 to 43 with a higher score indicating more severe symptoms. Values above 8 have been described as being indicative of neonatal abstinence syndrome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Abstinence Syndrome']}, 'descriptionModule': {'briefSummary': "Infants with neonatal abstinence syndrome (NAS) who are cared for in a Neonatal Intensive Care Unit (NICU) often display symptoms including hyperactivity, irritability, jitteriness, poor feeding, and poor sleep patterns. The recommended first line of treatment to relieve these symptoms involves nonpharmacological interventions. The purpose of the current pilot study is to provide preliminary data to assist in the design of a larger scale study to examine one nonpharmacological intervention, weighted blankets. The pilot study will assess the feasibility of a cross-over randomized controlled design to study the impact of a weighted blanket on infants' symptoms of NAS.\n\nThe aims of the study are:\n\nAim1: To determine the feasibility of recruiting patients for a study evaluating the use of weighted blankets in the care of infants with NAS Aim 2: To determine the feasibility and safety of the study procedures Aim 3: To examine whether there is clinical benefit to using weighted blankets for the treatment of symptoms in infants with NAS.\n\nAfter informed consent is obtained, infants will be randomized to have either a weighted blanket or a non-weighted blanket placed on them first. A cross-over design will be used so all infants will experience both the non-weighted and weighted blankets. Thirty minutes before each feeding, baseline vital signs and Finnegan score will be obtained. Then, a blanket (weighted or non-weighted) will be placed on the infant for 30 minutes. Infants will be directly monitored and on heart rate/respiratory rate monitors while the blanket is applied. Vital signs and Finnegan scores will be obtained at the end of 30 minutes of blanket placement, infants will be fed, and vital signs and Finnegan scores will be obtained again 30 minutes after the blanket was removed. Descriptive statistics will be used to determine the enrollment rate and feasibility of the protocol. Nonparametric statistics will be used to compare total Finnegan scores for infants with the weighted blanket applied compared to infants with a non-weighted blanket applied. Changes in Finnegan scores will be examined to estimate an effect size to use in a power analysis for a future larger effectiveness study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '37 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the NICU\n* Gestational age \\> 37 weeks\n* Positive maternal drug screen at delivery\n\nExclusion Criteria:\n\n* Clinical staff does not give permission to enroll the patient\n* Had intrauterine growth restriction (IUGR)\n* Has any medical diagnosis in addition to NAS diagnosis\n* Has a weight below the 10th percentile'}, 'identificationModule': {'nctId': 'NCT03113656', 'briefTitle': 'Weighted Blankets With Infants With NAS', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'The Use of Weighted Blankets in the Care of Infants With Neonatal Abstinence Syndrome (NAS)', 'orgStudyIdInfo': {'id': '17-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weighted Blanket First', 'description': 'This group will receive the Weighted Blanket first and then the Non-weighted blanket', 'interventionNames': ['Other: Weighted Blanket', 'Other: Non-Weighted Blanket']}, {'type': 'EXPERIMENTAL', 'label': 'Non-weighted Blanket First', 'description': 'This group will receive the Non-weighted Blanket first and then the Weighted blanket', 'interventionNames': ['Other: Weighted Blanket', 'Other: Non-Weighted Blanket']}], 'interventions': [{'name': 'Weighted Blanket', 'type': 'OTHER', 'description': 'Weighted blanket placed on infant for 30 minutes', 'armGroupLabels': ['Non-weighted Blanket First', 'Weighted Blanket First']}, {'name': 'Non-Weighted Blanket', 'type': 'OTHER', 'description': 'Non-Weighted blanket placed on infant for 30 minutes', 'armGroupLabels': ['Non-weighted Blanket First', 'Weighted Blanket First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse Researcher', 'investigatorFullName': 'Rachel Baker', 'investigatorAffiliation': 'TriHealth Inc.'}}}}