The HELP for NOWS Consortium is seeking interested clinical sites to participate in a new trial, Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach. OPTimize NOW is a cluster crossover trial that will examine the length of time from birth until medically ready for discharge between infants with neonatal opioid withdrawal syndrome (NOWS) treated with either a symptom-based (PRN) dosing approach or a scheduled opioid taper approach. Interested clinical sites must meet the following inclusion and exclusion criteria:

Inclusion Criteria

  1. The site is willing and able to transition to a symptom-based dosing approach at a randomly allocated time and is willing and able to transition from a symptom-based dosing approach to a scheduled opioid taper approach at a randomly allocated time.
  2. The site uses either the Eat, Sleep, and Console care approach or the Finnegan Neonatal Abstinence Scoring Tool or modification thereof to assess infants with NOWS and will continue to use the same assessment and management approach throughout the study.
  3. The site provides scheduled opioid treatment with morphine, methadone, or buprenorphine for infants with NOWS and has an established algorithm for a scheduled opioid taper prior to study initiation. The site agrees to maintain the type of opioid(s) used throughout the study.

Exclusion Criteria

  1. The site manages fewer than 5 infants who receive pharmacologic treatment for NOWS annually.
  2. The site routinely discharges/transfers infants from the hospital on opioid treatment (i.e., morphine, methadone, or buprenorphine). Routine is defined as ≥10% of infants who receive opioid treatment for NOWS at the time of hospital discharge.
  3. The site routinely uses more than one opioid type for the pharmacologic treatment of infants with NOWS. Routine is defined as ≥10% of infants who receive more than one opioid for the treatment of NOWS.
If your clinical site meets the above criteria and is interested in participating in this trial, please complete our online survey. Please reach out to helpfornows@rti.org with any questions.