The Eat, Sleep, Console approach, a function-based assessment of withdrawal severity, is increasingly used in infants with neonatal opioid withdrawal instead of subjective, observer-rated scales, such as the Finnegan Neonatal Abstinence Scoring Tool. However, there have been concerns about the potential for pharmacological undertreatment and premature discharge amid the rapid uptake of this approach without strong evidence to support it. A randomized controlled trial was performed to evaluate the efficacy, safety, and generalizability of the Eat, Sleep, Console approach as compared with usual care using the Finnegan tool.

The trial was conducted at 26 geographically diverse U.S. sites, including both academic centers and community hospitals. A total of 1,305 infants born at 36 weeks' gestation or more were enrolled. In randomized order, hospitals transitioned from usual care using the Finnegan tool to the Eat, Sleep, Console approach, after staff had received training in it.

Of the 1,305 infants enrolled, 837 met the trial definition of medical readiness for discharge. The mean length of time from birth until medical readiness for discharge was 8.2 days in the Eat, Sleep, Console group versus 14.9 days in the usual care group. The mean length of stay in the hospital was 7.8 days in the Eat, Sleep, Console group and 14 days in the usual care group, and the proportion of infants who received opioid treatment was 19.5% and 52%, respectively. The risk of adverse outcomes was similar in the two groups.

The authors point out that temporal trends, such as earlier newborn discharges during the COVID-19 pandemic and nurse staffing shortages, could have affected trial results. Another limitation was that postdischarge safety outcomes were limited to the first three months of age and based on electronic health records and media review.