Neurostimulation to Improve NOWS Outcomes

Not Applicable

Active, not recruiting

• Conditions: Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal Syndrome

• Registration Number: NCT05129020
• Lead Sponsor: Spark Biomedical, Inc.

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-11-22
• Study Start: 2022-07-27
• Primary Completion: 2024-12-25
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-02
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Finnegan Neonatal Abstinence Scoring System (FNASS)	Day 1 - Day 30 (or day of discharge)	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.
Median number of days of oral morphine medication administered to the infant after start of active or sham tAN treatment.	Duration of morphine administration

Secondary Outcome Measures

Name	Time	Method
Median length of hospital stay secondary to NOWS	Through inpatient treatment phase completion, an average of one month	Defined as the number of calendar days from date of birth through date of discharge
Neonatal Neurobehavioral Scale (NNNS-II)	Baseline, Day 7, Day 15, and Day 30 (or day of discharge)	The NNNS is a comprehensive and systematic assessment of an infant's response to a variety of items including handling, spontaneous behavior, motor activity and self-soothing as indicators of neurobehavioral performance. The NNNS examines neurobehavioral organization, neurological reflexes, motor development, active and passive tone, and signs of stress and withdrawal of the at-risk and drug-exposed infant. The NNNS document the range of withdrawal and stress behavior likely to be observed in intervention with substance-exposed infants. The scale consists of 13 domains: habituation, attention, arousal, regulation, handling procedures, quality of movement, excitability, lethargy, nonoptimal reflexes, asymmetric reflexes, hypertonicity, hypotonicity, and stress/abstinence scale. Summary scores are calculated and compared with percentile scores to determine how an infant compares with an at-risk sample. The NNNS has good psychometric properties and reliability.
Median length of hospital stay due to NOWS	Through inpatient treatment phase completion, an average of one month	Defined as the number of calendar days from first q3h opioid administration through the 48-hour observation period
Mean number of days from birth to medical readiness for discharge	From day of birth through discharge, an average of one month	Defined as the date where all of the following criteria are met: age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours without respiratory support and with 100% oral feeding, at least 24 hours from initiation of maximum caloric density
Mean number of days of oral morphine medication administered	Day 1 - Day 30 (or day of discharge)

Trial Locations

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