Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial.

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.

Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal.

BACKGROUND: Although clinicians have traditionally used the Finnegan Neonatal Abstinence Scoring Tool to assess the severity of neonatal opioid withdrawal, a newer function-based approach - the Eat, Sleep, Console care approach - is increasing in use. Whether the new approach can safely reduce the time until infants are medically ready for discharge when it is applied broadly across diverse sites is unknown. METHODS: In this cluster-randomized, controlled trial at 26 U.S. hospitals, we enrolled infants with neonatal opioid withdrawal syndrome who had been born at 36 weeks' gestation or more. At a randomly assigned time, hospitals transitioned from usual care that used the Finnegan tool to the Eat, Sleep, Console approach. During a 3-month transition period, staff members at each hospital were trained to use the new approach. The primary outcome was the time from birth until medical readiness for discharge as defined by the trial. Composite safety outcomes that were assessed during the first 3 months of postnatal age included in-hospital safety, unscheduled health care visits, and nonaccidental trauma or death. RESULTS: A total of 1305 infants were enrolled. 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. CONCLUSIONS: As compared with usual care, use of the Eat, Sleep, Console care approach significantly decreased the number of days until infants with neonatal opioid withdrawal syndrome were medically ready for discharge, without increasing specified adverse outcomes. (Funded by the Helping End Addiction Long-term (HEAL) Initiative of the National Institutes of Health; ESC-NOW ClinicalTrials.gov number, NCT04057820.).

Implementation of a Novel Tool to Collect Milk Feeding Data on Infants in Primary Care Clinics.

We aimed to capture milk feeding type in real time in a racially and socioeconomically diverse population. An electronic tool to assess milk feeding type at every medical visit for children aged 0 to 2 years was designed and incorporated into nursing workflows. The Milk Box tool was successfully added to the electronic clinical workspace of a large health system. There were eight clinics, with diverse characteristics, which incorporated the use of the Milk Box tool over 12 months. Time to 50% uptake of Milk Box varied from 3 to 5 months. Time to >80% uptake varied from 6 to 8 months. Our results show that Milk Box can be quickly incorporated into a clinical workflow when the team is given appropriate training and support. The tool also allows a primary care practice to study local breast milk consumption trends and to provide both individualized and system-level lactation support.

Influence of Early Lactation Assistance on Inpatient Exclusive Breastfeeding Rates.

BACKGROUND: Human milk feeding reduces the incidence and costs of several maternal and childhood illnesses. Initiation and success of human milk feeding are influenced by race, socioeconomic status, and family support. The influence of early in-hospital lactation assistance in breastfeeding success has been not well described. RESEARCH AIMS: We aimed to determine how suspected known factors influencing breastfeeding success influence in-hospital human milk feeding rates. Second, we aimed to examine how timing of lactation assistance is related to success of human milk feeding during the newborn hospitalization for healthy infants. METHODS: We conducted a retrospective cohort study of term infants born between January 1, 2014 and December 31, 2016 at a large tertiary academic hospital. We considered "success" to be 100% human milk feeding during the birth hospitalization, and compared differences in success by demographics, payor, race, and initial feeding preference. Influences of lactation assistance on success were analyzed using multivariable logistic regression. RESULTS: Mean success with exclusive human milk feeding among 7,370 infants was 48.9%, (n = 3,601). Successful participants were more likely to be 39-40 weeks' gestation (64.9%, n = 2,340), non-Hispanic/non-Latino (80.0%, n = 2,882), and using private insurance (69.2%, n = 2,491). Participants who had early feeding assisted by an International Board Certified Lactation Consultant (IBCLC) before being fed any formula were more likely to be successful than participants who had a feeding assisted by a non-IBCLC nurse (80% vs. 40% respectively). CONCLUSIONS: Success for exclusive human milk feeding during newborn hospitalization is strongly associated with several factors. Early intervention with IBCLCs can greatly improve breastfeeding success.

Success of a Resident-Led Safety Council: A Model for Satisfying CLER Pathways to Excellence Patient Safety Goals.

BACKGROUND: The Accreditation Council for Graduate Medical Education (ACGME) Clinical Learning Environment Review (CLER) program focuses on aspects of the graduate medical education learning environment, such as patient safety. Data from CLER site visits reveal that many resident physicians do not receive adequate training on patient safety. OBJECTIVE: We evaluated a pediatric resident-led safety council as a method to meet CLER Pathways to Excellence patient safety objectives. METHODS: The Duke Pediatric Residency Safety Council (PRSC) created an infrastructure for residents to participate in department safety efforts, review safety events, and act as leaders for safety initiatives. Annual surveys were distributed to graduate medical education trainees through the institution's patient safety center and the PRSC. Survey results of safety attitudes were compared over time within the pediatrics program and between pediatrics and nonpediatrics trainees at the institution. Resident-submitted safety reports were tracked through an institutional safety event repository. RESULTS: From 2013 to 2017, the percentage of residents who strongly agreed that they could submit a safety report doubled (from 35% [6 of 17] to 73% [22 of 30], P = .011). The average number of safety reports submitted by a pediatrics resident per year did not significantly change during this period (from 3.0 to 3.8, P = .11). In 2017, 90% of pediatrics residents (27 of 30) agreed or strongly agreed that their concerns would be addressed if they entered a safety report. CONCLUSIONS: The council addressed 5 of the 7 CLER Pathways to Excellence in patient safety.