Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
52 participants
INTERVENTIONAL
2022-07-27
2027-01-31
Brief Summary
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Detailed Description
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1. Group 1: Active tAN + Morphine
2. Group 2: Sham tAN + Morphine
Morphine dosing for all infants will be managed by using the Finnegan Neonatal Abstinence Scoring System (FNASS), recorded every three hours.
After 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active tAN + Morphine
Sparrow Fledging Therapy System
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.
Sham tAN + Morphine
Sham Sparrow Fledging Therapy System
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.
Interventions
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Sparrow Fledging Therapy System
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.
Sham Sparrow Fledging Therapy System
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.
Eligibility Criteria
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Inclusion Criteria
2. Clinically stable without respiratory support (exception for nasal cannula)
3. Congenital syndromes may be included if the infants do not have major, unrepaired anomalies
Exclusion Criteria
2. Repeated episodes of autonomic instability (apnea or bradycardia) which are not self-resolving
3. Major unrepaired congenital anomalies impacting respiratory or cardiovascular system
4. Cardiomyopathy
5. Abnormal ear anatomy preventing the device to fit
6. Infants diagnosed with iatrogenic NOWS
7. Infants two weeks of age or older (after birth)
8. Neonates who have received more than 6 methadone doses or 24 hours of methadone dosing
9. Infants who are wards of the state
10. 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
33 Weeks
1 Year
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
University of Texas Southwestern Medical Center
OTHER
University of Texas Health Science Center San Antonio
UNKNOWN
Spark Biomedical, Inc.
INDUSTRY
Responsible Party
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Locations
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Medical University of South Carolina - Shawn Jenkins Children's Hospital
Charleston, South Carolina, United States
UT Southwestern Medical Center / Parkland Memorial Hospital
Dallas, Texas, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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SBM-NOWS-02
Identifier Type: -
Identifier Source: org_study_id