Secondary outcomes
SECONDARY, RECURRENCE
The primary outcome will be the number of days of opioid treatment (used as primary treatment), including escalation, resumption, and spot treatment, from the first weaning dose to opioid cessation. We will assess the primary outcome by analyzing data from all infants undergoing rapid-wean, compared to slow-wean, with morphine or methadone. Predefined secondary analyses will examine the results for each opioid separately. We will define days on a 24-h basis, e.g., 18 h will represent 0.75 days. We will express days and dosages to the nearest hundredth, and we will round up at five. Days of opioid treatment is a single outcome that will be a function of (a) the weaning algorithm and (b) the extent of recurrence of NOWS signs. The use of hospital guidelines combined with study protocol guidelines will ensure that NOWS signs deemed clinically important result in appropriate treatment of the infant.