NCT04834297

Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome.

Completed NA Last updated 14 July 2025

What this trial tests

NA trial testing Prapela SVS mattress in Neonatal Opioid Withdrawal Syndrome in 120 participants. Completed in 10 June 2025.

Timeline

21 November 2021

Primary endpoint
10 June 2025

10 June 2025

Quick facts

Lead sponsor	Tufts Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	120
Start date	21 November 2021
Primary completion	10 June 2025
Estimated completion	10 June 2025
Sites	1 location across United States

Drugs / interventions tested

• Prapela SVS mattress

Conditions studied

• Neonatal Opioid Withdrawal Syndrome — all drugs for Neonatal Opioid Withdrawal Syndrome →

Sponsor

Tufts Medical Center

Who can join

Adults 0 Days to 2 Days, any sex, with Neonatal Opioid Withdrawal Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 neonatal abstinence syndrome (NAS). Between 2004 and 2016, NOWS admissions increased more than fourfold with an average hospital stay nearly 3.2 times longer (15.9 hospital days compared with 4.98) than for a non-NOWS patient resulting in a surge in annual costs to almost $573 million with 83% attributed to state Medicaid programs. While there is no accepted standard for treating NAS, non-pharmacological bundles are recommended, as an initial course of treatment moving to pharmacological care when required. Unfortunately, non-pharmacological care (swaddling, rocking, frequent feedings, and skin contact) require significant use of human resources. To reduce the increasing burden on limited resources, the evidence emerges that hospitals are trying to adapt baby products for consumers that were neither intended nor tested for use in NAS infants as part of their non-pharmacological bundle. The objective of this application is to establish the safety, efficacy, and acceptability of our hospital bassinet pad with stochastic vibrotactile stimulation (SVS) technology as an adjunctive, non-pharmacological treatment to improve the care of infants with NOWS. To accomplish the objective, the investigators plan to execute the following specific aims; 1) determine the efficacy of the SVS hospital bassinet pad, 2) demonstrate the safety of the SVS hospital bassinet pad, and 3) assess acceptability of the device with clinical staff and parents caring for infants with NOWS. The successful completion of the project will provide data to support FDA clearance for commercialization of this low-cost, non-pharmacological device to improve the clinical course of newborns with NOWS.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of stochastic vibro-tactile stimulation for newborns at risk of neonatal opioid withdrawal syndrome.
   Singh R, Trinquart L, Koethe B, Cordova M, et al · · 2026 · PMID 40410582 · DOI 10.1038/s41390-025-04162-2