Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT05129020
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2021-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurostimulation to Improve NOWS Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009357', 'term': 'Neonatal Abstinence Syndrome'}, {'id': 'D013375', 'term': 'Substance Withdrawal 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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-07', 'size': 3573067, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-22T14:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Each clinical site will have NICU nurses that will perform the Finnegan scale and be blind to the subjects' group designation. This will ensure a non-biased assessment of the Finnegan score, and importantly morphine dosing. Information regarding study intervention will be withheld from the blinded NICU nurses. NNNS assessors will also be blinded to information regarding study intervention to prevent biased NNNS scoring. All investigators will be blinded to subject treatment group."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is designed as a randomized, double-blind, sham-controlled, multi-center, clinical trial in which neonates diagnosed with Neonatal Opioid Withdrawal Syndrome (NOWS) will be randomized 1:1 into one of two treatment groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2021-11-04', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Median length of time to reach oral morphine control dose', 'timeFrame': 'Day 1 - Day 30 (or day of discharge)'}, {'measure': 'Mean total oral morphine delivered', 'timeFrame': 'Day 1 - Day 30 (or day of discharge)'}, {'measure': 'Proportion of infants with episode(s) of bradycardia', 'timeFrame': 'Day 1 - Day 30 (or day of discharge)'}, {'measure': 'Proportion of infants with episode(s) of apnea related to tAN', 'timeFrame': 'Day 1 - Day 30 (or day of discharge)'}, {'measure': 'Proportion of infants with episode(s) of laryngospasms related to tAN', 'timeFrame': 'Day 1 - Day 30 (or day of discharge)'}, {'measure': 'Neonatal Infant Pain Scale (NIPS)', 'timeFrame': 'Day 1 - Day 30 (or day of discharge)', 'description': 'The Neonatal Infant Pain Scale (NIPS) is a validated pain scale utilized in the NICU. There are six components to the NIPS: facial expression, crying, breathing patterns, arm and leg movements, and state of arousal. The NIPS scale scoring ranges from 0-7, with scores greater than 3 indicating discomfort. A score of 3 is similar to the pain level associated with a heel stick procedure to obtain blood and the maximum score of 6 is similar to a circumcision procedure without analgesia. This measure will be taken immediately prior to, during, and after tAN therapy.'}, {'measure': 'Number of infants with an Ages and Stages Questionnaire-3 (ASQ-3) Score greater than 2 standard deviations below the mean for any domain', 'timeFrame': 'At 3, 9, 18, and 24 months of age', 'description': 'The ASQ-3 is a parent-completed developmental screening tool that pinpoints developmental progress in children between the ages of one month to 5 ½ years. The ASQ-3 is a series of 19 age-specific questionnaires screening communication, gross motor, fine motor, problem-solving, and personal adaptive skills; results in a pass/fail score for domains.'}, {'measure': 'Number of infants who have scores outside of "typical performance", as calculated by a score greater than 1 standard deviation away from the mean, on the Sensory Profile 2 (SP-2)', 'timeFrame': 'At 3, 9, 18, and 24 months of age', 'description': "The SP-2 is a set of norm-referenced, parent and teacher questionnaires designed to assess the sensory processing patterns of children from birth through 14 years, 11 months. Information obtained from the Sensory Profile 2 helps identify ways sensory processing may be contributing to or interfering with a child's participation in home, school, and community. There are five different forms selected based on age: 1) Infant Sensory Profile 2 - Birth to 6 months; 2) Toddler Sensory Profile - 7 to 35 months; 3) Child Sensory Profile 2 - 3 to 15 years; 4) Short Sensory Profile 2 - 3 to 15 years; and 5) School Companion Sensory Profile 2 - 3 to 15 years. Each of the forms includes some combination of Sensory System, Behavioral, and Sensory Pattern scores."}, {'measure': 'Proportion of participants who do not meet criteria for normal neurodevelopment as measured by the Bayley Scale of Infant and Toddler Development III (BSID-III) or other neurodevelopmental assessment', 'timeFrame': 'At 24 months of age', 'description': 'The BSID-III is an extensive formal developmental assessment tool for diagnosing developmental delays in early childhood. The BSID-III has three main subtests; the Cognitive Scale, the Language Scale, and the Motor Scale.'}], 'primaryOutcomes': [{'measure': 'Median number of days of oral morphine medication administered to the infant after start of active or sham tAN treatment.', 'timeFrame': 'Duration of morphine administration'}, {'measure': 'Finnegan Neonatal Abstinence Scoring System (FNASS)', 'timeFrame': 'Day 1 - Day 30 (or day of discharge)', 'description': 'Finnegan Neonatal Abstinence Scoring System (FNASS) is a validated assessment tool designed to measure 21 signs of withdrawal in infants. The tool provides a means to rate severity of withdrawal symptoms every three hours after feeding using a standard format.'}], 'secondaryOutcomes': [{'measure': 'Median length of hospital stay due to NOWS', 'timeFrame': 'Through inpatient treatment phase completion, an average of one month', 'description': 'Defined as the number of calendar days from first q3h opioid administration through the 48-hour observation period'}, {'measure': 'Median length of hospital stay secondary to NOWS', 'timeFrame': 'Through inpatient treatment phase completion, an average of one month', 'description': 'Defined as the number of calendar days from date of birth through date of discharge'}, {'measure': 'Neonatal Neurobehavioral Scale (NNNS-II)', 'timeFrame': 'Baseline, Day 7, Day 15, and Day 30 (or day of discharge)', 'description': "The NNNS is a comprehensive and systematic assessment of an infant's response to a variety of items including handling, spontaneous behavior, motor activity and self-soothing as indicators of neurobehavioral performance. The NNNS examines neurobehavioral organization, neurological reflexes, motor development, active and passive tone, and signs of stress and withdrawal of the at-risk and drug-exposed infant. The NNNS document the range of withdrawal and stress behavior likely to be observed in intervention with substance-exposed infants. The scale consists of 13 domains: habituation, attention, arousal, regulation, handling procedures, quality of movement, excitability, lethargy, nonoptimal reflexes, asymmetric reflexes, hypertonicity, hypotonicity, and stress/abstinence scale. Summary scores are calculated and compared with percentile scores to determine how an infant compares with an at-risk sample. The NNNS has good psychometric properties and reliability."}, {'measure': 'Mean number of days of oral morphine medication administered', 'timeFrame': 'Day 1 - Day 30 (or day of discharge)'}, {'measure': 'Mean number of days from birth to medical readiness for discharge', 'timeFrame': 'From day of birth through discharge, an average of one month', 'description': 'Defined as the date where all of the following criteria are met: age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours without respiratory support and with 100% oral feeding, at least 24 hours from initiation of maximum caloric density'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['auricular neurostimulation', 'vagus nerve stimulation', 'transcutaneous', 'withdrawal symptoms'], 'conditions': ['Neonatal Opioid Withdrawal Syndrome', 'Neonatal Abstinence Syndrome']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.', 'detailedDescription': "This study is designed as a randomized, double-blind, sham-controlled, multi-center, clinical trial in which neonates diagnosed with Neonatal Opioid Withdrawal Syndrome (NOWS) will be randomized 1:1 into one of two treatment groups:\n\n1. Group 1: Active tAN + Morphine\n2. Group 2: Sham tAN + Morphine\n\nMorphine dosing for all infants will be managed by using the Finnegan Neonatal Abstinence Scoring System (FNASS), recorded every three hours.\n\nAfter the participant exits the inpatient treatment phase of the study, they will enter the neurodevelopmental follow-up phase. The participant's parent or legal guardian will be contacted at 3, 9, 18, and 24 months of age to complete the Ages and Stages Questionnaire (ASQ-3) and the Sensory Profile 2 (SP-2). At 24 months, participants who fail in any sub-domain will be referred to their primary care physician for further neurodevelopmental assessment using the Bayley Scale of Infant and Toddler Development III (BSID-III) or other neurodevelopmental assessment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '33 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Neonates or infants \\>33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy\n2. Clinically stable without respiratory support (exception for nasal cannula)\n3. Congenital syndromes may be included if the infants do not have major, unrepaired anomalies\n\nExclusion Criteria\n\n1. Unstable infants\n2. Repeated episodes of autonomic instability (apnea or bradycardia) which are not self-resolving\n3. Major unrepaired congenital anomalies impacting respiratory or cardiovascular system\n4. Cardiomyopathy\n5. Abnormal ear anatomy preventing the device to fit\n6. Infants diagnosed with iatrogenic NOWS\n7. Infants two weeks of age or older (after birth)\n8. Neonates who have received more than 6 methadone doses or 24 hours of methadone dosing\n9. Infants who are wards of the state\n10. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial"}, 'identificationModule': {'nctId': 'NCT05129020', 'acronym': 'SPROUT', 'briefTitle': 'Neurostimulation to Improve NOWS Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spark Biomedical, Inc.'}, 'officialTitle': 'Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome', 'orgStudyIdInfo': {'id': 'SBM-NOWS-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tAN + Morphine', 'interventionNames': ['Device: Sparrow Fledging Therapy System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tAN + Morphine', 'interventionNames': ['Device: Sham Sparrow Fledging Therapy System']}], 'interventions': [{'name': 'Sparrow Fledging Therapy System', 'type': 'DEVICE', 'description': 'tAN sessions will be administered up to four times per day for up to 20 days total. Active tAN will be set to run for 30 minutes one hour prior to each planned morphine dose. When the 30-minute tAN session is complete, the system will be turned off and unplugged.', 'armGroupLabels': ['Active tAN + Morphine']}, {'name': 'Sham Sparrow Fledging Therapy System', 'type': 'DEVICE', 'description': 'Participants randomized to the sham group will have the device earpiece applied at the same timepoints and for the same duration as the active group, but stimulation will not be turned on. tAN sessions will be administered up to four times per day for up to 20 days total. Sham tAN will be set to run for 30 minutes one hour prior to each planned morphine dose. When the 30-minute tAN session is complete, the system will be turned off and unplugged.', 'armGroupLabels': ['Sham tAN + Morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': "Medical University of South Carolina - Shawn Jenkins Children's Hospital", 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center / Parkland Memorial Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spark Biomedical, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medical University of South Carolina', 'class': 'OTHER'}, {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, {'name': 'University of Texas Health Science Center San Antonio', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}