Status:
COMPLETED
Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome.
Lead Sponsor:
Tufts Medical Center
Conditions:
Neonatal Opioid Withdrawal Syndrome
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
Maternal use and addiction to opioids has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal opioid withdrawal syndrome (NOWS), also referred to as neonat...
Detailed Description
In preliminary work using a research grade device, the investigators tested stochastic vibrotactile stimulation (SVS) in infants with NOWS. Twenty six full term infants who were opioid exposed, as det...
Eligibility Criteria
Inclusion
- 1\. Infants ≥ 35 weeks gestation with prenatal opioid exposure
Exclusion
- Infants \< 35 weeks gestational age at birth
- Infants receiving opioids for non-NOWS indications
- Infants with congenital anomalies
- Infants with known central nervous system anomalies
- Infants with seizures unrelated to opioid withdrawal
- Infants with hydrocephalus
- Infants with intraventricular hemorrhage ≥ grade 2 (Papille Scale)
- Infants with severe anemia (hemoglobin \< 8)
- Infants with suspected and/or confirmed infection
- Infants deemed to be clinically unstable by their medical provider
- Multiple births
Key Trial Info
Start Date :
November 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04834297
Start Date
November 21 2021
End Date
June 10 2025
Last Update
July 14 2025
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111