SVS Device for Opioid Withdrawal in Newborns
What You Need to Know Before You Apply
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.
Who Is on the Research Team?
Rachana Singh, MD, MS
Principal Investigator
Tufts Medical Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive the SVS mattress within 48 hours of birth and continue until day 5 or until pharmacologic treatment is initiated
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Prapela SVS mattress
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts Medical Center
Lead Sponsor