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Neurostimulation to Improve NOWS Outcomes
Sponsor: Spark Biomedical, Inc.
Summary
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.
Official title: Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome
Key Details
Gender
All
Age Range
33 Weeks - 1 Year
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2022-07-27
Completion Date
2027-01-31
Last Updated
2025-12-31
Healthy Volunteers
No
Interventions
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.
Locations (3)
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