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Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome
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.
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: 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.
Age
0 - 1 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 27, 2022
Primary Completion Date
January 31, 2025
Completion Date
January 31, 2027
Last Updated
December 31, 2025
52
ACTUAL participants
Sparrow Fledging Therapy System
DEVICE
Sham Sparrow Fledging Therapy System
DEVICE
Lead Sponsor
Spark Biomedical, Inc.
Collaborators
NCT04783558
NCT04419857
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04214834