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Introducing the first and only medical device to receive authorization from the Food and Drug Administration to treat newborns exposed to opioids before birth.
Neonatal Opioid Withdrawal Syndrome (NOWS)
One of the more sorrowful consequences of our opioid crisis is the use of opioids among pregnant women and the impact on newborns. Prenatal opioid exposure (POE) can result in a postnatal withdrawal condition in newborns called neonatal opioid withdrawal syndrome (NOWS). Babies with NOWS experience hyperirritability, sweating, irregular heart and breathing rates, fever, vomiting, and diarrhea.
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The American Academy of Pediatrics (AAP) indicates non-pharmacological interventions as the first-line treatment for NOWS. These treatments - such as swaddling, rooming-in, and skin-to-skin care require intensive caregiver interaction, which is often not sustainable.
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On April 4, 2025 the FDA granted De Novo to the Prapela SVS hospital bassinet pad, making it the first medical device with FDA marketing authorization to treat NOWS.
Diagnosis
A diagnosis of NOWS requires in-utero exposure to opioids, confirmed by history but not necessarily by toxicology testing. A second condition is the presence of “at least two of the most common clinical signs characteristic of withdrawal - excessive crying, fragmented sleep, tremors, increased muscle tone, gastrointestinal function.
Prenatal Opioid Exposure and NOWS - Current Practices
Assessment
Historically, the Finnegan Neonatal Abstinence Scoring System was the most widely used method to diagnose NOWS. Since 2019, the Eat, Sleep & Console (ESC) has gained strong acceptance in the medical community. The ESC assessment examines a newborn’s ability to eat an expected amount based on gestational age, sleep after eating for at least an hour, and be consoled with 10 minutes of soothing. A recent retrospective study including 2,375 newborns with POE revealed no differences in pharmacotherapy, length of treatment, and length of stay between the two assessment methods.
Treatment
Nonpharmacological treatment refers to a bundle of different types of supportive care, including removal of environmental stimuli, rooming-in, swaddling and positioning, rocking, swaying, frequent feedings, and skin-to-skin contact/kangaroo care.
Pharmacological treatment while may itself contribute to long-term development issues, the AAP supports the use of an opioid as a first-line pharmacotherapy treatment to manage severe withdrawal symptoms. An estimated 33% to 80% of newborns treated for NOWS receive medication to manage severe withdrawal symptoms.
Prevelance & Cost
130% increase
From 2010 to 2017, maternal use of opioids increased 130%, resulting in 8.2 out of every 1000 babies born in the United States with POE.
55% to 95%
of newborns with POE develop withdrawal symptoms.
9 - 16 Days
is overall mean length of hospital stay (LOS) for NOWS babies
$1.5 Billion
In the United States, annual hospital charges for NOWS have been reported to exceed $1.5 billion annually, with more than 2/3rds, billed to Medicaid.
