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 range33 Weeks – 1 Year

SexALL

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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

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