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
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Opioid Withdrawal Syndrome||Other: Prapela SVS mattress||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
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
|Contact: Rachana Singh, MD, MSfirstname.lastname@example.org|
|Contact: John Konsin||833-772-7352||JohnKonsin@prapela.com|
|Principal Investigator:||Rachana Singh, MD, MS||Tufts Medical Center|