Active — Not RecruitingNot Applicable

Neurostimulation to Improve NOWS Outcomes

United States52 participantsStarted 2022-07-27

Plain-language 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.

Who can participate

Age range

33 Weeks – 1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Duration of morphine administration

Finnegan Neonatal Abstinence Scoring System (FNASS)

Timeframe: Day 1 - Day 30 (or day of discharge)

Trial details

NCT IDNCT05129020

SponsorSpark Biomedical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-31

View on ClinicalTrials.gov More Neonatal Opioid Withdrawal Syndrome trials