Neurostimulation to Improve NOWS Outcomes (SPROUT)

Spark Biomedical

Status: Active, not recruiting

Conditions: Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal Syndrome

Treatments: Device: Sparrow Fledging Therapy System; Device: Sham Sparrow Fledging Therapy System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05129020

SBM-NOWS-02

Details and patient eligibility

About

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.

Full 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:

1. Group 1: Active tAN + Morphine
2. 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.

Enrollment: 52 patients

Sex: All

Ages: 33 weeks to 1 year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Neonates or infants >33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy
2. Clinically stable without respiratory support (exception for nasal cannula)
3. Congenital syndromes may be included if the infants do not have major, unrepaired anomalies

Exclusion Criteria

1. Unstable infants
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
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups

Active tAN + Morphine

Experimental group

Treatment:

Device: Sparrow Fledging Therapy System

Sham tAN + Morphine

Sham Comparator group

Treatment:

Device: Sham Sparrow Fledging Therapy System