Neurostimulation to Improve NOWS Outcomes

N/AActive Not RecruitingNCT05129020

Spark Biomedical, Inc.52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Neonatal Opioid Withdrawal Syndrome Neonatal Abstinence Syndrome

Interventions

Sparrow Fledging Therapy SystemDEVICE

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 SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 33 WeeksMax age: 1 Year

Medical Language ↔ Plain English

Inclusion Criteria 1. Neonates or infants \>33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy 2. Clinically stable without respiratory support (exception for nasal cannula) 3. Congenital syndromes may be included if the infants do not have major, unrepaired anomalies Exclusion Criteria 1. Unstable infants 2. Repeated episodes of autonomic instability (apnea or bradycardia) which are not self-resolving 3. Major unrepaired congenital anomalies impacting respiratory or cardiovascular system 4. Cardiomyopathy 5. Abnormal ear anatomy preventing the device to fit 6. Infants diagnosed with iatrogenic NOWS 7. Infants two weeks of age or older (after birth) 8. Neonates who have received more than 6 methadone doses or 24 hours of methadone dosing 9. Infants who are wards of the state 10. 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

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

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: Day 1 - Day 30 (or day of discharge)

Secondary Outcomes

Median length of hospital stay due to NOWS

Defined as the number of calendar days from first q3h opioid administration through the 48-hour observation period

Time frame: Through inpatient treatment phase completion, an average of one month

Median length of hospital stay secondary to NOWS

Defined as the number of calendar days from date of birth through date of discharge

Time frame: Through inpatient treatment phase completion, an average of one month

Neonatal Neurobehavioral Scale (NNNS-II)

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.

Data from ClinicalTrials.gov

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