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

NCT04834297 | Completed DMC

• 1 other identifier: STUDY00001552
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neonatal Opioid Withdrawal Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of participants requiring pharmacologic treatment of NOWS

  All the infants enrolled in the study will be assessed for the need of pharmacological management of NOWS with initiation of morphine sulfate, based on either the modified Finnegan score or ESC tool.

  Baseline up to Day 5 of life

Secondary Outcomes (4)

• Mean daily percentage of time characterized as pain or fussy crying

  Baseline up to day 5 of life

• Mean modified Finnegan score

  Baseline up to day 5 of life

• Mean ESC score

  Baseline up to day 5 of life

• Mean number of days until readiness for hospital discharge

  Duration of hospital stay, an expected average of 11 days

Study Arms (2)

SVS mattress

EXPERIMENTAL

Infants randomized to the experimental arm will have the SVS mattress placed in their crib within 48 hours of birth and will continue till discharge home after the completion of monitoring phase of NOWS or till determination is made to initiate pharmacotherapy for NOWS.

Other: Prapela SVS mattress

Standard mattress

NO INTERVENTION

Infants randomized to the no intervention arm will continue to be cared for using the standard hospital crib mattress throughout their birth hospitalization.

Interventions

Prapela SVS mattress OTHER

The intervention will be using the Prapela SVS crib mattress to complement non-pharmacological management of NOWS for the purposes of prevention of pharmacological treatment of NOWS

SVS mattress

Eligibility Criteria

• Age: 0 Days - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Infants ≥ 35 weeks gestation with prenatal opioid exposure

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Singh R, Trinquart L, Koethe B, Cordova M, Rhein L, Bibi S, Fey J, Anderson A, Davis JM. Efficacy of stochastic vibro-tactile stimulation for newborns at risk of neonatal opioid withdrawal syndrome. Pediatr Res. 2025 May 23. doi: 10.1038/s41390-025-04162-2. Online ahead of print.

  PMID: 40410582 DERIVED

Study Officials

• Rachana Singh, MD, MS

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 8, 2021
• Study Start: November 21, 2021
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)