1. In this randomized controlled trial, the Eat, Sleep, Console approach resulted in a significantly shortened time to medical readiness for discharge in neonates with opioid withdrawal syndrome.
2. There was no significant difference between usual care and the Eat, Sleep, Console approach in the incidence of adverse outcomes.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Neonatal opioid withdrawal syndrome results from exposure to opioids in utero. Clinical signs can include seizures, irritability, and gastrointestinal issues. Historically, subjective and observation-based scoring systems such as the Finnegan Neonatal Abstinence Scoring Tool have been used to determine which infants with neonatal opioid withdrawal syndrome receive treatment. However, a focal criticism of this approach is that it overestimates the need for infants to be treated pharmacologically. A newer care tool, known as the Eat, Sleep Console approach, shifts the focus to a functional assessment of the infant paired with prioritization of non-pharmacological means of treatment and a focus on caregiver empowerment. The focus of this multi-center, cluster-randomized trial was to evaluate the efficacy and safety of this new approach compared to usual care. The primary results of the study found that the Eat, Sleep, Console approach helped to significantly shorten the time between birth to when neonates were medically ready for discharge compared to usual care. Further, it did not demonstrate an increased risk of adverse safety outcomes compared to usual care. A primary limitation of the study is the unmasked design. Overall, the Eat, Sleep, Console approach is an effective means of reducing time to discharge for patients with neonatal opioid withdrawal syndrome.
Click to read the study in NEJM
In-Depth [randomized controlled trial]: This was a cluster-randomized, unmasked, controlled trial evaluating the effect of the Eat, Sleep, Console care approach on time-to-discharge for neonates with opioid withdrawal syndrome. The primary outcome of interest was the time from birth to medical readiness for discharge, with secondary outcomes of interest including the total length of stay, receipt of pharmacological treatment, and safety outcomes. Infants born full-term with evidence of antenatal opioid exposure and who were undergoing treatment for opioid withdrawal were included in the study. Participants were randomized by sites into one of eight blocks, with the overall study including a total of 1,305 infants. Primary results of the analysis found that the Eat, Sleep, Console group demonstrated a significantly shorter time between birth until medically ready for discharge compared to the usual-care group (adjusted mean difference, 6.7 days; 95% Confidence Interval [CI], 4.7 to 8.8). The Eat, Sleep, Console group also demonstrated a shorter mean length of hospital stay compared to usual care (rate ratio, 0.56; 95% CI, 0.49 to 0.64). There was no difference in safety outcomes between the groups. In summary, this study provided evidence that the Eat, Sleep, Console approach may be superior to usual care with respect to shortening the length of time between birth to medical readiness for discharge, and total length of stay, with no differences in risk of adverse outcomes. Long-term follow-up of the infants will provide greater insight into safety outcomes following discharge.
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