Neonatal Opioid Withdrawal SyndromeSPROUTNCT05129020
Neurostimulation to Improve NOWS Outcomes
A study testing Sparrow Fledging Therapy System in people with Neonatal Opioid Withdrawal Syndrome and Neonatal Abstinence Syndrome, run by Spark Biomedical, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 33 weeks to 1 year
- Conditions the study is for
- Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
- What is being tested?
- Sparrow Fledging Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jul 2022to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 weeks to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University of South Carolina - Shawn Jenkins Children's Hospital
Charleston, South Carolina, 29425
UT Southwestern Medical Center / Parkland Memorial Hospital
Dallas, Texas, 75235
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
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.
- Being tested
- Sparrow Fledging Therapy System, Sham Sparrow Fledging Therapy System
- Keywords
- auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms
- Medical subject headings
- Neonatal Abstinence Syndrome, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tAN + Morphine | Experimental | Not described Receives: Device: Sparrow Fledging Therapy System |
| Sham tAN + Morphine | Sham comparator | Not described Receives: Device: Sham Sparrow Fledging Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median number of days of oral morphine medication administered to the infant after start of active or sham tAN treatment.
Measured: 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.
Measured: Day 1 - Day 30 (or day of discharge)
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: Baseline, Day 7, Day 15, and Day 30 (or day of discharge)
Mean number of days of oral morphine medication administered
Measured: Day 1 - Day 30 (or day of discharge)
Mean number of days from birth to medical readiness for discharge
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
Measured: From day of birth through discharge, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start27 Jul 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Opioid Withdrawal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spark Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina, University of Texas Southwestern Medical Center, The University of Texas Health Science Center at San Antonio, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129020
- Sponsor's protocol ID
- SBM-NOWS-02
- Other IDs
- 2R44DA050360
- Acronym
- SPROUT
- Status last verified
- Jun 2026
- First submitted
- 4 Nov 2021
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share participant data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome
- ClinicalTrials.gov ID
- NCT05129020
- Acronym / sponsor ID
- SPROUT / SBM-NOWS-02
- Keywords
- auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Spark Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina, University of Texas Southwestern Medical Center, The University of Texas Health Science Center at San Antonio, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active tAN + Morphine | Experimental | Device: Sparrow Fledging Therapy System |
| Sham tAN + Morphine | Sham comparator | Device: Sham Sparrow Fledging Therapy System |
Who may qualify
- Ages
- 33 weeks to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sparrow Fledging Therapy SystemtAN 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. | Device | Active tAN + Morphine |
| Sham Sparrow Fledging Therapy SystemParticipants 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. | Device | Sham tAN + Morphine |
Primary outcome
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)
Time frame: 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.
5 secondary outcomes
Median length of hospital stay due to NOWS
Time frame: Through inpatient treatment phase completion, an average of one month
Median length of hospital stay secondary to NOWS
Time frame: Through inpatient treatment phase completion, an average of one month
Neonatal Neurobehavioral Scale (NNNS-II)
Time frame: Baseline, Day 7, Day 15, and Day 30 (or day of discharge)
Mean number of days of oral morphine medication administered
Time frame: Day 1 - Day 30 (or day of discharge)
Mean number of days from birth to medical readiness for discharge
Time frame: From day of birth through discharge, an average of one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. There is no plan to share participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sparrow Fledging Therapy System in people with Neonatal Opioid Withdrawal Syndrome and Neonatal Abstinence Syndrome, run by Spark Biomedical, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.