Compared with usual care in 1,305 infants with neonatal opioid withdrawal syndrome, the Eat, Sleep, Console care approach significantly decreased the number of days until infants were medically ready for discharge, a study shows. The investigators found no evidence of short-term harms and support “long-term follow-up … to further inform the safety of this approach.”
The cluster-randomized, controlled trial enrolled infants with neonatal opioid withdrawal syndrome who had been born at 36 weeks’ gestation or more at 26 U.S. hospitals. Hospitals transitioned from usual care that used the Finnegan tool to the Eat, Sleep, Console approach at a randomly assigned time. Hospital staff members were trained in the new approach during a 3-month transition period. The Eat, Sleep, Consoled care approach includes a function-based assessment of opioid withdrawal severity that focuses on the ability to eat, sleep, and be consoled; assessment for taking more than 10 minutes for feeding or breastfeeding or taking in less than 10 mL, sleeping for less than 1 hour, and taking more than 10 minutes to be consoled; optimization of nonpharmacologic interventions; and empowerment of families or caregivers.
Based on a primary outcome of the time from birth until medical readiness for discharge and composite safety outcomes during the first 3 months of postnatal age, the investigators found: “In an intention-to-treat analysis that included 837 infants who met the trial definition for medical readiness for discharge, the number of days from birth until readiness for hospital discharge was 8.2 in the Eat, Sleep, Console group and 14.9 in the usual-care group (adjusted mean difference, 6.7 days; 95% confidence interval [CI], 4.7 to 8.8), for a rate ratio of 0.55 (95% CI, 0.46 to 0.65; P <0.001). The incidence of adverse outcomes was similar in the two groups.”