Neurostimulation to Improve NOWS Outcomes
Purpose
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.
Conditions
- Neonatal Opioid Withdrawal Syndrome
- Neonatal Abstinence Syndrome
Eligibility
- Eligible Ages
- Between 33 Weeks and 1 Year
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention 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.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Each clinical site will have NICU nurses that will perform the Finnegan scale and be blind to the subjects' group designation. This will ensure a non-biased assessment of the Finnegan score, and importantly morphine dosing. Information regarding study intervention will be withheld from the blinded NICU nurses. NNNS assessors will also be blinded to information regarding study intervention to prevent biased NNNS scoring. All investigators will be blinded to subject treatment group.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active tAN + Morphine |
|
|
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Sham Comparator Sham tAN + Morphine |
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Recruiting Locations
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- Spark Biomedical, Inc.
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: 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.