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

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ClinicalTrials.gov Identifier: NCT04834297
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

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.

Condition or disease Intervention/treatment Phase
Neonatal Opioid Withdrawal Syndrome Other: Prapela SVS mattress Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prapela™ SVS: A Cost-effective Stochastic Vibro-tactile Stimulation Device to Improve the Clinical Course of Infants With Neonatal Opioid Withdrawal Syndrome.
Estimated Study Start Date : September 15, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : May 31, 2023

Arm Intervention/treatment
Experimental: SVS mattress
Infants randomized to the experimental arm will have the SVS mattress placed in their crib within 24 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
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

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



Primary Outcome Measures :
  1. Failure of treatment as measured by need for pharmacotherapy for Neonatal Opioid Withdrawal Syndrome (NOWS). [ Time Frame: 5-7 days ]
    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 Finnegan scores.


Secondary Outcome Measures :
  1. Periods of cries characterized as fussy, hungry or in pain for infants with NOWS [ Time Frame: 5-7 days ]
    This will be assessed by the analyzing the cry recordings and utilizing the Chatterbaby App algorithms for data analyses



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Infants ≥ 37 weeks gestation with prenatal opioid exposure

Exclusion Criteria:

  1. Infants < 37 weeks gestational age at birth
  2. Infants receiving opioids for non-NOWS indications
  3. Infants with congenital anomalies
  4. Infants with known central nervous system anomalies
  5. Infants with seizures unrelated to opioid withdrawal
  6. Infants with hydrocephalus
  7. Infants with intraventricular hemorrhage ≥ grade 2 (Papille Scale)
  8. Infants with severe anemia (hemoglobin < 8)
  9. Infants with suspected and/or confirmed infection
  10. Infants deemed to be clinically unstable by their medical provider

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04834297


Contacts
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Contact: Rachana Singh, MD, MS 617-636-5322 rsingh2@tuftsmedicalcenter.org
Contact: John Konsin 833-772-7352 JohnKonsin@prapela.com

Locations
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United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Rachana Singh, MD, MS    617-636-5322    rsingh2@tuftsmedicalcenter.org   
Contact: Allison Nolan    617-636-5322    anolan1@tuftsmedicalcenter.org   
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Rachana Singh, MD, MS Tufts Medical Center
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT04834297    
Other Study ID Numbers: STUDY00001552
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Substance Withdrawal Syndrome
Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders