Opioid-exposed newborns deserve more. Now there’s an FDA-authorized device to treat them, and the evidence to back it up.

Author: John Konsin, Principal Founder, Prapela, Inc. | April 23, 2026

Prapela is pleased to make our Clinical Evidence Summary available to clinicians, NICU leaders, and care teams managing NAS/NOWS. This peer-reviewed resource covers:

✅ The pivotal study, Bloch-Salisbury et al. RCT (JAMA Pediatrics, 2023, n=181).
✅ The Singh et al. multicenter RCT (Pediatric Research, 2025) — showing a clinically meaningful trend toward reduced pharmacotherapy and earlier discharge across 6 hospitals using both ESC and Finnegan protocols.
✅ Supporting physiological safety data from Zuzarte et al. (PLoS ONE, 2017).
✅ Five verified ESC outcome studies (2023–2024), including the landmark ESC-NOW trial in NEJM.
✅ A critical look at why motion-based bassinets are not equivalent to Prapela’s stochastic therapy and what the data shows
✅ Prapela SVS FDA De Novo authorization (April 2025) — the only medical device indicated to treat opioid-exposed newborns

Whether your institution uses ESC, Finnegan, or a hybrid approach, Prapela SVS is designed to work within your existing framework — no workflow changes required.

Request your copy at prapela.com