SVS Device for Opioid Withdrawal in Newborns

Overseen By John Konsin

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Disqualifiers: Congenital anomalies, CNS anomalies, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 5 days

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Rachana Singh, MD, MS

Principal Investigator

Tufts Medical Center

Eligibility Criteria

This trial is for newborns who are at least 37 weeks gestation and have been exposed to opioids before birth. It's not for babies with severe anemia, those considered unstable by their doctors, or those with certain medical conditions like hydrocephalus, infections, congenital anomalies, or seizures not related to opioid withdrawal.

Inclusion Criteria

My baby was born at or after 37 weeks and was exposed to opioids before birth.

Exclusion Criteria

My infant has severe anemia with hemoglobin less than 8.

Newborns with birth defects.

My infant is suspected or confirmed to have an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

1 visit (in-person)

Treatment

Infants receive the SVS mattress within 48 hours of birth and continue until day 5 or until pharmacologic treatment is initiated

5 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 days

Daily assessments

Treatment Details

Interventions

• Prapela SVS mattress

Trial Overview The trial is testing a special mattress called the Prapela SVS that uses vibrations (SVS technology) as a non-drug treatment to help newborns with neonatal opioid withdrawal syndrome (NOWS). The study aims to see if this mattress is safe, effective, and acceptable in hospital settings.

Participant Groups

Group I: SVS mattress Experimental Treatment 1 Intervention

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.

Group II: Standard mattress Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+