Neurostimulation to Improve NOWS Outcomes

NCT05129020 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: SBM-NOWS-022R44DA050360
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Neonatal Opioid Withdrawal Syndrome; Neonatal Abstinence Syndrome

Keywords

auricular neurostimulation; vagus nerve stimulation; transcutaneous; withdrawal symptoms

Outcome Measures

Primary Outcomes (2)

• Median number of days of oral morphine medication administered to the infant after start of active or sham tAN treatment.

  Duration of morphine administration

• Finnegan Neonatal Abstinence Scoring System (FNASS)

  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.

  Day 1 - Day 30 (or day of discharge)

Secondary Outcomes (5)

• Median length of hospital stay due to NOWS

  Through inpatient treatment phase completion, an average of one month

• Median length of hospital stay secondary to NOWS

  Through inpatient treatment phase completion, an average of one month

• Neonatal Neurobehavioral Scale (NNNS-II)

  Baseline, Day 7, Day 15, and Day 30 (or day of discharge)

• Mean number of days of oral morphine medication administered

  Day 1 - Day 30 (or day of discharge)

• Mean number of days from birth to medical readiness for discharge

  From day of birth through discharge, an average of one month

Other Outcomes (9)

• Median length of time to reach oral morphine control dose

  Day 1 - Day 30 (or day of discharge)

• Mean total oral morphine delivered

  Day 1 - Day 30 (or day of discharge)

• Proportion of infants with episode(s) of bradycardia

  Day 1 - Day 30 (or day of discharge)

Study Arms (2)

Active tAN + Morphine

EXPERIMENTAL

Device: Sparrow Fledging Therapy System

Sham tAN + Morphine

SHAM COMPARATOR

Device: Sham Sparrow Fledging Therapy System

Interventions

Sham Sparrow Fledging Therapy System DEVICE

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.

Sham tAN + Morphine

Sparrow Fledging Therapy System DEVICE

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.

Active tAN + Morphine

Eligibility Criteria

• Age: 33 Weeks - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates or infants \>33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy
• Clinically stable without respiratory support (exception for nasal cannula)
• Congenital syndromes may be included if the infants do not have major, unrepaired anomalies

You may not qualify if:

• Unstable infants
• Repeated episodes of autonomic instability (apnea or bradycardia) which are not self-resolving
• Major unrepaired congenital anomalies impacting respiratory or cardiovascular system
• Cardiomyopathy
• Abnormal ear anatomy preventing the device to fit
• Infants diagnosed with iatrogenic NOWS
• Infants two weeks of age or older (after birth)
• Neonates who have received more than 6 methadone doses or 24 hours of methadone dosing
• Infants who are wards of the state
• 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

Sponsors & Collaborators

• Spark Biomedical, Inc.: lead
• Medical University of South Carolina: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• University of Texas Southwestern Medical Center: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (3)

Medical University of South Carolina - Shawn Jenkins Children's Hospital

Charleston, South Carolina, 29425, United States

Location

UT Southwestern Medical Center / Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome; Substance Withdrawal Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 22, 2021
• Study Start: July 27, 2022
• Primary Completion: January 31, 2025
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)