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ACTIVE NOT RECRUITING
NCT05129020
NA

Neurostimulation to Improve NOWS Outcomes

Sponsor: Spark Biomedical, Inc.

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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