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 : January 27, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Neonatal Opioid Withdrawal Syndrome||Other: Prapela SVS mattress||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 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.|
|Actual Study Start Date :||November 21, 2021|
|Estimated Primary Completion Date :||December 30, 2023|
|Estimated Study Completion Date :||May 31, 2024|
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.
- 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.
- 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.
- 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.
- 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.
- 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|
1. Infants ≥ 37 weeks gestation with prenatal opioid exposure
- Infants < 37 weeks gestational age at birth
- Infants receiving opioids for non-NOWS indications
- Infants with congenital anomalies
- Infants with known central nervous system anomalies
- Infants with seizures unrelated to opioid withdrawal
- Infants with hydrocephalus
- Infants with intraventricular hemorrhage ≥ grade 2 (Papille Scale)
- Infants with severe anemia (hemoglobin < 8)
- Infants with suspected and/or confirmed infection
- Infants deemed to be clinically unstable by their medical provider
- Multiple births
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, MSemail@example.com|
|Contact: John Konsin||833-772-7352||JohnKonsin@prapela.com|
|United States, Massachusetts|
|Tufts Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Rachana Singh, MD, MS 617-636-5322 firstname.lastname@example.org|
|Contact: Allison Nolan 617-636-5322 email@example.com|
|Principal Investigator:||Rachana Singh, MD, MS||Tufts Medical Center|
|Responsible Party:||Tufts Medical Center|
|Other Study ID Numbers:||
|First Posted:||April 8, 2021 Key Record Dates|
|Last Update Posted:||January 27, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Substance Withdrawal Syndrome