Available population
RECRUITMENT
In the fall of 2017, a ISPCTN and NRN site survey found that during a 1-year period, there were approximately 2700 infants exposed to opioids, of which, medical professionals pharmacologically treated approximately 43%. Among those treated pharmacologically, medical professionals treated 76% with morphine, 24% with methadone, and 4% with buprenorphine. These observations provide a starting to point to estimate the number of participants available for this trial. However, there is some uncertainty regarding how many NOWS infants would meet the inclusion criteria without meeting any exclusion criteria (Exclusion Criteria, Section 1). In addition, there may be changes in hospital practices within the ISPCTN and NRN given ongoing NOWS initiatives. Multiple clinical trials have not achieved enrollment of the projected sample size [15, 17, and 18], and we expect low consent rates in this population. Use of the Recruitment Plan was associated with a 35% consent rate at Women and Infants Hospital for the methadone vs morphine trial conducted by Davis et al. [Estimated enrollment per year