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Neurostimulation to Improve NOWS Outcomes (SPROUT)

Primary Purpose

Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sparrow Fledging Therapy System
Sham Sparrow Fledging Therapy System
Sponsored by
Spark Biomedical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Opioid Withdrawal Syndrome focused on measuring auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms

Eligibility Criteria

33 Weeks - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Neonates or infants >33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy
  2. Clinically stable or on minimal respiratory support (continuous positive airway pressure [CPAP], nasal cannula, or room air)
  3. Stable neonates who are dependent on opioids following extracorporeal membrane oxygenation, severe illness, or brain injury will be included in this study as these neonates represent a population in which tAN could minimize withdrawal while not adding burden of pharmacotherapies
  4. Congenital syndromes may be included if the infants do not have major, unrepaired anomalies

Exclusion Criteria

  1. Unstable infants or those requiring significant respiratory support
  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 without intrauterine exposure
  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

Sites / Locations

  • Medical University of South Carolina - Shawn Jenkins Children's HospitalRecruiting
  • UT Southwestern Medical Center / Parkland Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tAN + Morphine

Sham tAN + Morphine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Median length of hospital stay due to NOWS
Median length of hospital stay secondary to NOWS
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.

Full Information

First Posted
November 4, 2021
Last Updated
September 5, 2023
Sponsor
Spark Biomedical, Inc.
Collaborators
Medical University of South Carolina, University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05129020
Brief Title
Neurostimulation to Improve NOWS Outcomes
Acronym
SPROUT
Official Title
Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spark Biomedical, Inc.
Collaborators
Medical University of South Carolina, University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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: Group 1: Active tAN + Morphine 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Keywords
auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tAN + Morphine
Arm Type
Experimental
Arm Title
Sham tAN + Morphine
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Sparrow Fledging Therapy System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Sparrow Fledging Therapy System
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Finnegan Neonatal Abstinence Scoring System (FNASS)
Description
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 Outcome Measure Information:
Title
Median length of hospital stay due to NOWS
Time Frame
Through study completion, an average of one month
Title
Median length of hospital stay secondary to NOWS
Time Frame
Through study completion, an average of one month
Title
Neonatal Neurobehavioral Scale (NNNS-II)
Description
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.
Time Frame
Baseline, Day 7, Day 15, and Day 30 (or day of discharge)
Other Pre-specified Outcome Measures:
Title
Neonatal Infant Pain Scale (NIPS)
Description
The Neonatal Infant Pain Scale (NIPS) is a validated pain scale utilized in the NICU. There are six components to the NIPS: facial expression, crying, breathing patterns, arm and leg movements, and state of arousal. The NIPS scale scoring ranges from 0-7, with scores greater than 3 indicating discomfort. A score of 3 is similar to the pain level associated with a heel stick procedure to obtain blood and the maximum score of 6 is similar to a circumcision procedure without analgesia. This measure will be taken immediately prior to, during, and after tAN therapy.
Time Frame
Day 1 - Day 30 (or day of discharge)
Title
Median length of time to reach oral morphine control dose
Time Frame
Duration of morphine administration
Title
Mean total oral morphine delivered
Time Frame
Duration of morphine administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
33 Weeks
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Neonates or infants >33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy Clinically stable or on minimal respiratory support (continuous positive airway pressure [CPAP], nasal cannula, or room air) Stable neonates who are dependent on opioids following extracorporeal membrane oxygenation, severe illness, or brain injury will be included in this study as these neonates represent a population in which tAN could minimize withdrawal while not adding burden of pharmacotherapies Congenital syndromes may be included if the infants do not have major, unrepaired anomalies Exclusion Criteria Unstable infants or those requiring significant respiratory support 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 without intrauterine exposure 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Benner
Phone
8179332727
Email
caroline.benner@sparkbiomedical.com
Facility Information:
Facility Name
Medical University of South Carolina - Shawn Jenkins Children's Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Morris, RN
Email
morrjess@musc.edu
First Name & Middle Initial & Last Name & Degree
Dorothea Jenkins, MD
Facility Name
UT Southwestern Medical Center / Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Mazioniene, RN
Email
kathryn.mazioniene@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Asmahan Ahmed, RN
Email
asmahan.ahmed@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Lorraine Bautista, MD
First Name & Middle Initial & Last Name & Degree
Venkat Kakkilaya, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share participant data.

Learn more about this trial

Neurostimulation to Improve NOWS Outcomes

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