OPTimize NOW - HEAL Evaluation of Limited Pharmacotherapies for Neonatal Opioid Withdrawal Syndrome (HELP for NOWS)

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Abstract OPTimize NOW Thitinart Sithisarn, MD Antenatal opioid exposure may result in neonatal opioid withdrawal syndrome (NOWS). Neonatal opioid withdrawal is characterized by dysfunction in 3 primary areas: 1) the central nervous system, 2) the autonomic nervous system and 3) the gastrointestinal system. Signs of withdrawal include but are not limited to irritability, tremors, increased tone, hyperthermia, poor sleep, poor feeding, vomiting and diarrhea. The natural history of NOWS is an initial increase in symptoms as placentally transferred opioids are cleared from the infant’s system. With time, withdrawal symptoms will eventually abate. The therapeutic focus is on the reduction of symptom severity, with a goal of ensuring normal infant growth and development and maternal-infant bonding. A focus on a function-based approach to care in addition to optimization of non-pharmacologic care, including a low stimulation environment, swaddling, clustered care and the provision of mother’s own milk coupled, when possible, with infant caregiver engagement to provide skin-to-skin care, and on demand breastfeeding has been shown to be effective as first line treatment for infants with NOWS and is endorsed by the American Academy of Pediatrics (AAP) [1]. If non-pharmacologic care alone does not mitigate the severity of opioid withdrawal, pharmacologic treatment is indicated. The traditional approach to pharmacologic treatment for infants with NOWS is initiation and escalation of opioid treatment until symptoms are controlled followed by a slow opioid taper. This approach has been shown to be efficacious but is associated with extended opioid courses and prolonged hospitalization, both of which have been associated with suboptimal developmental outcomes. The use of pro re nata (PRN) or symptom-based dosing has been evaluated as a way to decrease postnatal pharmacologic exposure for infants with NOWS. Conceptually, a PRN approach would allow control of symptoms for infants who have severity of disease that borders on the usual trigger for the extended treatment protocol. One to three doses of an opioid in such infants may be enough to control symptoms sufficiently and allow for non-pharmacologic therapies to be the primary mechanism for symptom control. This approach could avoid a prolonged course of treatment and weaning for a subset of infants with milder disease, but as an emerging approach it has not been validated. Quality improvement (QI) initiatives conducted in single centers and small regional collaboratives have demonstrated a decrease in the duration of pharmacologic treatment and the length of hospital stay with the use of a PRN (i.e., symptom-based) approach as compared to an opioid taper approach. Improved short-term outcomes with a symptom-based dosing approach to pharmacologic treatment have been noted in infants assessed and managed with either the Eat, Sleep, and Console approach (ESC) or the Finnegan Neonatal Abstinence Assessment Tool (FNAST) [2-5]. In addition, the rate of readmission within 30 days of hospital discharge, a balancing measure used in the QI initiatives, was not increased with a symptom-based dosing approach when compared to a slow opioid taper.
Effective start/end date9/1/238/31/24


  • Research Triangle Institute


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