Earpiece could cut morphine use for Opioid-Dependent newborns

NCT ID NCT05129020

Ongoing Symptom relief Sponsor: Spark Biomedical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a gentle nerve-stimulating earpiece can help newborns going through opioid withdrawal. The device is used up to four times a day for 20 days, just before each morphine dose. Researchers want to see if it reduces the number of days babies need morphine and how long they stay in the hospital.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Sparrow Fledging Therapy System (a nerve-stimulating earpiece)
What this could lead to: If it works, this could offer a drug-free way to ease withdrawal in newborns, reducing their need for morphine and shortening hospital stays.
What could go wrong: This is a small, early-stage study with only 52 infants, so results may not apply to all babies. The sham group gets no stimulation, so any benefit might be due to placebo or natural recovery.

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Conditions

The condition(s) this trial relates to.

neonatal abstinence syndrome substance withdrawal syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NEONATAL ABSTINENCE SYNDROME NEONATAL OPIOID WITHDRAWAL SYNDROME

Contacts and locations

Locations

Medical University of South Carolina - Shawn Jenkins Children's Hospital

Charleston, South Carolina, 29425, United States
UT Southwestern Medical Center / Parkland Memorial Hospital

Dallas, Texas, 75235, United States
University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

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