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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 : December 8, 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 : 120 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.
Actual Study Start Date : November 21, 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. Number of participants requiring pharmacologic treatment of NOWS [ Time Frame: Baseline up to Day 5 of life ]
    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.


Secondary Outcome Measures :
  1. Mean daily percentage of time characterized as pain or fussy crying [ Time Frame: Baseline up to day 5 of life ]
    This outcome is calculated as the total daily duration of crying categorized as pain or fussy by the ChatterBaby algorithm, divided by 24 hours. For each participant, we will consider the daily percentage of time characterized as pain or fussy crying, from randomization to Day 5 of life or initiation of pharmacologic treatment for NOWS (whichever occurs first). This will be analyzed using mixed effects linear regression models.

  2. Mean modified Finnegan score [ Time Frame: Baseline up to day 5 of life ]
    The modified Finnegan score is measured on a scale from 0 to 45. Larger scores indicate more severe symptoms of withdrawal. For participants assessed with the modified Finnegan score, we will consider the daily average score, from randomization to Day 5 of life or initiation of pharmacologic treatment for NOWS. We will analyze the repeated measures of the daily average modified Finnegan score by using mixed effects linear regression models.

  3. Mean ESC score [ Time Frame: Baseline up to day 5 of life ]
    An ESC score will be calculated based on the count of symptoms present on the assessment tool, ranging from 0 to 3. Larger scores indicate more severe symptoms of withdrawal. For participants assessed with the ESC tool, we will consider the daily average score, from randomization to Day 5 of life or initiation of pharmacologic treatment for NOWS. We will analyze the repeated measures of the daily average ESC score by using mixed effects linear regression models.

  4. Mean number of days until readiness for hospital discharge [ Time Frame: Duration of hospital stay, an expected average of 11 days ]
    Measured as the number of days to readiness of discharge from hospital. We will compare the distributions of the number of days until readiness for discharge by using a negative binomial regression model.



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Ages Eligible for Study:   0 Days 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
  11. Multiple births

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: December 8, 2021
Last Verified: November 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