Rationale and summary
7,848,808A
DISORDER, SEPARATION, SECONDARY, RECURRENCE
Medical professionals pharmacologically treat NOWS infants when non-pharmacological therapy is inadequate to control NOWS signs. The survey data indicate that medical professionals pharmacologically treat a substantial proportion of NOWS infants. There are heterogeneous practices in all aspects of pharmacological treatment (treatment thresholds, initiation, medication type, initial dose, second-line and third-line medications, weaning algorithm, and home therapy). One trial cannot address all the knowledge gaps, and there is limited evidence to guide current clinical management. Clinical trials for this group of patients are challenging for multiple reasons. First, multiple prior randomized trials closed before meeting the projected sample size due to an inability to enroll subjects [Given the uncertainty of the specific opioid medical professionals will use to treat NOWS in the future, the ideal clinical trial would inform clinical practice for the use of either morphine or methadone. To that end, the proposed study is a pragmatic trial to determine whether a rapid-weaning intervention reduces the number of days of opioid treatment, compared to a slow-weaning intervention, and we powered the proposed study to detect a 2-day difference in the length of treatment. Hospitals will be able to use either morphine or methadone with the knowledge that we may find a positive treatment effect for both, one, or neither drugs. We are planning secondary analyses to separately examine the results for each opioid.The rapidity at which a clinical team can perform weaning with infant tolerance without recurrence of NOWS signs is unknown. In a randomized trial of morphine versus methadone in which clinical teams weaned the drug by 10% of the stabilization dose [Shortening the weaning phase of NOWS treatment has the potential to impact healthcare costs and minimize the separation of the mother-infant dyad. Opioid use disorder is estimated to occur in 6.5/1000 hospitalizations for infant delivery [Births per year in the USA: ≈ 4,000,000 birthsPercent births ≥ 36 weeks: ≈ 90% × 4 million → 3,600,000Opioid exposed: 6.5/1000 deliveriesTotal opioid exposed: 6.5 × 3600 → 23,400Opioid exposed receiving pharmacological treatment: 38.6% × 23,400 → 9032Cost of care/day: $869 × 9032 → $7,848,808A treatment reduction of 2.0 days would reduce healthcare costs by more than $15.7 million per year across the USA. Potential cost savings would be even greater for hospitals that care for infants with NOWS in facilities with higher levels of care (e.g., NICU, special care nurseries).If successful, this clinical trial would achieve the overarching goals of research initiatives for NOWS [