Clinical Evidence Base

Publications & References

Peer-reviewed citations supporting Prapela SVS clinical evidence — including the pivotal RCT, supporting clinical trial, and verified ESC literature (2023–2024).

Prapela SVS Pivotal Clinical Trial
Randomized Clinical Trial
Bloch-Salisbury E, Wilson JD, Rodriguez N, Bruch T, McKenna L, Derbin M, Glidden B, Ayturk D, Aurora S, Yanowitz T, Barton B, Vining M, Beers SR, & Bogen DL.
Efficacy of a Vibrating Crib Mattress to Reduce Pharmacologic Treatment in Opioid-Exposed Newborns: A Randomized Clinical Trial.
JAMA Pediatrics. 2023;177(7):665–674.
PMID: 37003713 https://doi.org/10.1001/jamapediatrics.2023.1077
Prapela SVS Supporting Clinical Trial
Supporting Trial
Zuzarte I, Indic P, Barton B, Paydarfar D, Bednarek F, Bloch-Salisbury E.
Vibrotactile Stimulation: A Non-pharmacological Intervention for Opioid-Exposed Newborns.
PLoS ONE. 2017;12(4):e0175981.
PMID: 28437438 https://doi.org/10.1371/journal.pone.0175981
ESC Literature (2023–2024) — Verified PubMed-Indexed Citations
Cluster RCT
Young LW, Ounpraseuth ST, Merhar SL, Hu Z, Simon AE, Bremer AA, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Poindexter BB, Higgins RD, Walsh MC, et al.; ACT NOW Collaborative.
Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal.
N Engl J Med. 2023;388(25):2326–2337.
PMID: 37125831 https://doi.org/10.1056/NEJMoa2214470
Post Hoc Subgroup Analysis
Devlin LA, Hu Z, Merhar SL, Ounpraseuth ST, Simon AE, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, et al.; NICHD Neonatal Research Network.
Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial.
JAMA Pediatr. 2024;178(6):525–532.
PMID: 38619854 https://doi.org/10.1001/jamapediatrics.2024.0544
Review
Mascarenhas M, Wachman EM, Chandra I, Xue R, Sarathy L, Schiff DM.
Advances in the Care of Infants With Prenatal Opioid Exposure and Neonatal Opioid Withdrawal Syndrome.
Pediatrics. 2024;153(2):e2023062871.
PMID: 38178779 https://doi.org/10.1542/peds.2023-062871
Meta-Analysis
Chu L, Liu X, Xu C.
Eat, Sleep, Console Model for Neonatal Opioid Withdrawal Syndrome: A Meta-Analysis.
Front Pediatr. 2024;12:1416383.
PMID: 39220152 https://doi.org/10.3389/fped.2024.1416383
QI Cohort Study
Halloum H, Daniels BJ, Beville D, Thrasher K, Martin GC, Ellsworth MA.
Implementation of a Nurse-Driven Eat-Sleep-Console (ESC) Treatment Pathway at a Community Hospital for Treatment of Neonatal Opioid Withdrawal Syndrome in an Effort to Improve Short-term Outcomes.
Adv Neonatal Care. 2024;24(3):212–218.
PMID: 38127593 https://doi.org/10.1097/ANC.0000000000001123
Epidemiological Data Sources

Agency for Healthcare Research and Quality (AHRQ). HCUP Kids’ Inpatient Database (KID), 2016, 2019, 2022. Healthcare Cost and Utilization Project.
https://www.ahrq.gov/data/hcup/

AHRQ HCUP Fast Stats — NAS State-Level Rates 2018–2023.
https://datatools.ahrq.gov/hcup-fast-stats

Kaiser Family Foundation / T-MSIS Medicaid Analysis — Maternal OUD Estimates.
https://www.kff.org/medicaid/opioid-use-disorder-and-treatment-among-pregnant-and-postpartum-medicaid-enrollees/

Important Notice

This document is intended for healthcare professionals only. It is provided for informational and educational purposes. All clinical decisions should be made by qualified medical personnel in accordance with applicable clinical guidelines, institutional protocols, and individual patient circumstances. ESC study citations should be verified via PubMed (pubmed.ncbi.nlm.nih.gov) for final DOIs and full-text access. Prapela SVS must be used in accordance with its FDA-authorized indication and Instructions for Use.

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