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Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup
Lori A Devlin1, Zhuopei Hu2, Stephanie L Merhar3
1Department of Pediatrics, University of Louisville School of Medicine, Louisville, Kentucky.
Insights
The eat, sleep, console (ESC) care approach reduced opioid exposure and hospital stay for infants with neonatal opioid withdrawal syndrome (NOWS). Pharmacologic treatment was initiated later but did not increase peak opioid dose.
Area of Science:
- Neonatal care
- Pharmacology
- Public Health
Background:
- The eat, sleep, console (ESC) care approach reduces pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS).
- Concerns exist regarding increased postnatal opioid exposure in infants requiring pharmacologic treatment under the ESC approach.
- The impact of the ESC approach on hospital outcomes for pharmacologically treated infants with NOWS remains unclear.
Purpose of the Study:
- To compare opioid exposure and length of hospital stay (LOS) in infants treated pharmacologically for NOWS using the ESC care approach versus usual care.
- To analyze differences in total opioid exposure and LOS for infants receiving pharmacologic treatment for NOWS.
Main Methods:
- A post hoc subgroup analysis of the ESC-NOW trial, a stepped-wedge cluster randomized clinical trial.
- Involved infants receiving pharmacologic treatment for NOWS at 26 US hospitals between September 2020 and March 2022.
- Generalized linear mixed models were used to analyze outcomes, adjusting for study design and patient characteristics.
Main Results:
- Infants in the ESC care approach group had significantly lower mean total opioid exposure (4.8 MME/kg vs 8.9 MME/kg) and shorter mean LOS (16.7 vs 22.9 days) compared to the usual care group.
- Pharmacologic treatment initiation was delayed in the ESC group (75.4 hours vs 53.0 hours), but peak opioid dose did not differ significantly.
- Mean length of opioid treatment was also shorter in the ESC group (11.8 days vs 18.1 days).
Conclusions:
- The ESC care approach is associated with reduced opioid exposure and shorter hospital stays for infants requiring pharmacologic treatment for NOWS.
- The ESC approach does not increase peak opioid dose, although treatment initiation is typically later.
- These findings suggest the ESC approach offers improved hospital outcomes for pharmacologically treated infants with NOWS.
Importance:
The function-based eat, sleep, console (ESC) care approach substantially reduces the proportion of infants who receive pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS). This reduction has led to concerns for increased postnatal opioid exposure in infants who receive pharmacologic treatment. However, the effect of the ESC care approach on hospital outcomes for infants pharmacologically treated for NOWS is currently unknown.
Objective:
To evaluate differences in opioid exposure and total length of hospital stay (LOS) for pharmacologically treated infants managed with the ESC care approach vs usual care with the Finnegan tool.
Design, Setting, And Participants:
This post hoc subgroup analysis involved infants pharmacologically treated in ESC-NOW, a stepped-wedge cluster randomized clinical trial conducted at 26 US hospitals. Hospitals maintained pretrial practices for pharmacologic treatment, including opioid type, scheduled opioid dosing, and use of adjuvant medications. Infants were born at 36 weeks' gestation or later, had evidence of antenatal opioid exposure, and received opioid treatment for NOWS between September 2020 and March 2022. Data were analyzed from November 2022 to January 2024.
Exposure:
Opioid treatment for NOWS and the ESC care approach.
Main Outcomes And Measures:
For each outcome (total opioid exposure, peak opioid dose, time from birth to initiation of first opioid dose, length of opioid treatment, and LOS), we used generalized linear mixed models to adjust for the stepped-wedge design and maternal and infant characteristics.
Results:
In the ESC-NOW trial, 463 of 1305 infants were pharmacologically treated (143/603 [23.7%] in the ESC care approach group and 320/702 [45.6%] in the usual care group). Mean total opioid exposure was lower in the ESC care approach group with an absolute difference of 4.1 morphine milligram equivalents per kilogram (MME/kg) (95% CI, 1.3-7.0) when compared with usual care (4.8 MME/kg vs 8.9 MME/kg, respectively; P = .001). Mean time from birth to initiation of pharmacologic treatment was 22.4 hours (95% CI, 7.1-37.7) longer with the ESC care approach vs usual care (75.4 vs 53.0 hours, respectively; P = .002). No significant difference in mean peak opioid dose was observed between groups (ESC care approach, 0.147 MME/kg, vs usual care, 0.126 MME/kg). The mean length of treatment was 6.3 days shorter (95% CI, 3.0-9.6) in the ESC care approach group vs usual care group (11.8 vs 18.1 days, respectively; P < .001), and mean LOS was 6.2 days shorter (95% CI, 3.0-9.4) with the ESC care approach than with usual care (16.7 vs 22.9 days, respectively; P < .001).
Conclusion And Relevance:
When compared with usual care, the ESC care approach was associated with less opioid exposure and shorter LOS for infants pharmacologically treated for NOWS. The ESC care approach was not associated with a higher peak opioid dose, although pharmacologic treatment was typically initiated later.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04057820.
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