← Back to Search

SVS Device for Opioid Withdrawal in Newborns

N/A
Recruiting
Led By Rachana Singh, MD, MS
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants ≥ 37 weeks gestation with prenatal opioid exposure
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of hospital stay, an expected average of 11 days
Awards & highlights

Study Summary

This trial is testing a bassinet pad with a vibration feature to see if it helps babies with opioid withdrawal.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the intervention involves using a vibrating mattress designed for comfort without medication involved, there may be minimal side effects. However, safety assessments will monitor any potential adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born at or after 37 weeks and was exposed to opioids before birth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of hospital stay, an expected average of 11 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of hospital stay, an expected average of 11 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants requiring pharmacologic treatment of NOWS
Secondary outcome measures
Mean ESC score
Mean daily percentage of time characterized as pain or fussy crying
Mean modified Finnegan score
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SVS mattressExperimental Treatment1 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 mattressActive Control1 Intervention
Infants randomized to the no intervention arm will continue to be cared for using the standard hospital crib mattress throughout their birth hospitalization.

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
256 Previous Clinical Trials
255,617 Total Patients Enrolled
Rachana Singh, MD, MSPrincipal InvestigatorTufts Medical Center
1 Previous Clinical Trials
68 Total Patients Enrolled

Media Library

Prapela SVS mattress Clinical Trial Eligibility Overview. Trial Name: NCT04834297 — N/A
Neonatal Opioid Withdrawal Syndrome Research Study Groups: Standard mattress, SVS mattress
Neonatal Opioid Withdrawal Syndrome Clinical Trial 2023: Prapela SVS mattress Highlights & Side Effects. Trial Name: NCT04834297 — N/A
Prapela SVS mattress 2023 Treatment Timeline for Medical Study. Trial Name: NCT04834297 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical investigation include geriatric participants?

"This trial is suitable for neonates, with an age range of 0 Days to 1 Day. There are 381 trials catered to people aged less than 18 years old and 997 dedicated to those over 65."

Answered by AI

How many participants are being admitted to this research endeavor?

"Affirmative. The clinical trial, which was first published on November 21st 2021, is recruiting participants according to information found at clinicaltrials.gov. A total of 120 people are wanted between one medical centre."

Answered by AI

What is the ultimate objective of this scientific investigation?

"This trial will assess the primary outcome of treatment failure amongst participants over a span of 5-7 days. Secondary outcomes include changes in modified Finnegan scores, number of cries classified as pain analysed via cry recordings and Chatterbaby App algorithms, and mean modified Finnegan score (measured on a scale from 0 to 45 with higher values indicating more severe symptoms). Statistical analysis for repeated measures daily average of modified Finnegan scores will be conducted using mixed effects linear regression models."

Answered by AI

Is it possible to join this research project?

"To meet the criteria of this research trial, participants must be suffering from syndrome and have a age between newborns to 1 day. Approximately 120 people are necessary for enrolment."

Answered by AI

Is there any availability for participants in this investigation?

"According to clinicaltrials.gov, this trial is currently enrolling suitable participants. It was initially posted on the 21st of November 2021 and its information has been updated as recently as 24th of that same month."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome.
2021. "Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04834297.
~11 spots leftby Aug 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top