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.).

Project CAPE: a high-fidelity, in situ simulation program to increase Critical Access Hospital Emergency Department provider comfort with seriously ill pediatric patients.

OBJECTIVES: Variation exists between the qualities of emergency department (ED) care provided to urban versus rural pediatric patients. We implemented a pediatric simulation program in the Critical Access Hospital (CAH) ED setting and evaluated whether this training would increase provider comfort with seriously ill children. METHODS: Five CAH hospitals conducted 6 scenarios for 12 months. Baseline surveys assessed ED staff exposure to and comfort with children. Surveys were repeated after 6 and 12 months. Respondents' answers were matched longitudinally. Changes in responses over time were analyzed using paired t tests for continuous variables. Changes in frequencies and percentages of categorical variables over time were analyzed using χ test. Scenario participants completed an additional survey at the end of each simulation. RESULTS: The baseline survey was completed by 104 of 150 eligible participants, giving a 71% response rate. Fifty-eight percent completed at least 1 additional survey. On survey 1, mean provider comfort score for procedures was 69 (0-100 point scale). Scores increased 6 points from surveys 1 to 2 and a total of 6.5 points from surveys 1 to 3 (P < 0.05).One hundred fifty postscenario surveys were completed. Of the providers, 83.7% believed that scenario participation increased their comfort with children. One hundred percent of the providers in month 12 felt that they would benefit from additional scenarios. CONCLUSIONS: An in situ pediatric simulation program can be implemented effectively in CAH EDs and results in increased comfort with pediatric patients. Such a program could be used as the core feature of a CAH education program aimed at improving the quality of pediatric emergency services provided at these safety net institutions.

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.

Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Infants with neonatal opioid withdrawal syndrome (NOWS) cared for with the Eat, Sleep, Console (ESC) care approach receive less pharmacologic treatment and have shorter hospital stays compared to usual care with the Finnegan Neonatal Abstinence Scoring Tool, but the effects of these approaches on feeding and weight are unknown. Objective: To evaluate feeding practices and weight trajectories in infants cared for with ESC vs usual care. Design, Setting, and Participants: ESC-NOW is a cluster randomized trial of infants with NOWS born at 36 weeks' gestation or later at 26 US hospitals from September 2020 to March 2022. Each site transitioned from usual care to ESC (the study intervention) at a randomized time. Feeding was per site practice and not specified by the intervention. Feeding and weight outcomes were assessed at hospital discharge. Intervention: ESC vs usual care. Main Outcomes and Measures: Outcomes include prospectively identified secondary end points related to feeding and weight. z Scores were used for growth to account for corrected gestational age at the time of measurement. All analyses were intention to treat and adjusted for study design. Maternal/infant characteristics were included in adjusted models. Results: The analyses included 1305 infants (702 in usual care and 603 in ESC; mean [SD] gestational age, 38.6 [1.3] weeks; 655 [50.2%] male and 650 [49.8%] female). Baseline demographic characteristics were similar between groups. The proportion of breastfed infants was higher in the ESC group (52.7% vs 41.7%; absolute difference, 11%; 95% CI, 1.0-20.9). A higher proportion of infants cared for with ESC received exclusive breast milk (15.1% vs 6.7%; absolute difference, 8.4%; 95% CI, 0.9-5.8) or any breast milk (38.8% vs 27.4%; absolute difference, 11.4%; 95% CI, 0.2-23.1) and were directly breastfeeding at discharge (35.2% vs 19.5%; absolute difference, 15.7%; 95% CI, 4.1-27.3). There was no difference in proportion of infants with weight loss greater than 10% or maximum percentage weight loss, although infants cared for with ESC had a lower weight z score on day of life 3 (-1.08 vs -1.01; absolute difference, 0.07; 95% CI, 0.02-0.12). When pharmacologic treatment was added into the model, no breastfeeding outcomes were statistically significant. Conclusions and Relevance: In this study, infants cared for with ESC were more likely to initiate and continue breastfeeding and had no difference in percentage weight loss. The improvement in breastfeeding with ESC may be driven by reduction in pharmacologic treatment and provision of effective nonpharmacologic care. Trial Registration: ClinicalTrials.gov Identifier: NCT04057820.

Increasing utilisation of a rebound hyperbilirubinaemia calculator in two newborn nurseries.

Neonatal hyperbilirubinaemia requiring phototherapy treatment is a common problem impacting the length of hospital stay and rates of hospital readmission. Previous guidelines included guidance for initiating phototherapy treatment but not for discontinuing phototherapy treatment during initial newborn admission.In response to dissatisfaction from trainees, staff and families regarding the variable approach to discontinuing phototherapy among attending nursery providers, we used quality improvement methodologies to increase utilisation of a rebound hyperbilirubinaemia calculator as a more consistent method for guiding the timing of phototherapy discontinuation. The aim was to increase utilisation of the rebound hyperbilirubinaemia calculator for newborns treated with phototherapy in two newborn nurseries to >90% within 2 years.Sequential interventions focused on increasing provider awareness of the rebound hyperbilirubinaemia calculator and making the calculator simple to access and use.At the university medical centre nursery, the use of the calculator increased from 8.7% to 100%, exceeding the project goal. In the community hospital nursery, there was a statistically significant increase in the rate of utilisation from 3.7% to 79.4%, but this fell slightly below the goal of >90%.Electronic Health Record integration, along with education and addition of prompts to providers, increased utilisation of a rebound hyperbilirubinaemia calculator as a consistent approach for guiding decisions about discontinuing phototherapy treatment in newborns.

Quality improvement initiative to improve infant safe sleep practices in the newborn nursery.

The American Academy of Pediatrics recommends that healthcare professionals model their safe infant sleeping environment recommendations, yet adherence to safe sleep practices within our community hospital mother-baby unit was low. We used quality improvement (QI) methodology to increase adherence to infant safe sleep practices, with a goal to improve the proportion of infants sleeping in an environment that would be considered 'perfect sleep' to 70% within a 1-year period. The project occurred while the hospital was preparing for Baby Friendly certification, with increased emphasis on rooming in and skin to skin at the same time.Multiple Plan-Do-Study-Act cycles were performed. Initial cycles targeted nurse and parental education, while later cycles focused on providing sleep sacks/wearable blankets for the infants.While we did not meet our goal, the percentage of infants with 'perfect sleep' increased from a baseline of 41.9% to 67.3%, and we also saw improvement in each of the individual components that contribute to this composite measure. Improvements were sustained over 12 months later, suggesting that QI interventions targeting infant safe sleep in this inpatient setting can have long-lasting results. This project also suggests that infant safe sleep QI initiatives and preparation towards Baby Friendly Hospital Certification can be complementary.

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.

Improving adherence to hepatitis B vaccine administration recommendations in two newborn nurseries.

Administration of the birth dose of hepatitis B vaccine is an important step in reducing perinatally acquired hepatitis B infection, yet the USA is below the Healthy People 2020 goal for rate of administration.In response to updated Advisory Committee on Immunisation Practices recommendations to administer the dose within 24 hours of birth, we used quality improvement methodology to implement changes that would increase the vaccination rates of healthy newborns in our nurseries. The goal was to improve the proportion of infants who receive the hepatitis B vaccine within 24 hours of birth to >90% within a 2-year period, with a secondary goal of increasing vaccination rates prior to discharge from the nursery to >95%.Multiple Plan-Do-Study-Act (PDSA) cycles were performed. Initial cycles focused on increasing nurse and provider awareness of the updated timing recommendations. Later cycles targeted nursing workflow to facilitate timely administration of the vaccine. We implemented changes at our university medical centre and community hospital newborn nurseries.At the university medical centre nursery, both primary and secondary goals were met; the rate of hepatitis B vaccine administration within 24 hours increased from 81.7% to 96.2%, with vaccine administration prior to discharge increasing from 93.4% to 97.9%. In the community hospital nursery, the baseline rate of hepatitis B vaccine administration within 24 hours was 78.1%, and this increased to 85.8% with the interventions, falling short of the target of >90%. Vaccine administration prior to discharge increased from 87.2% to 92.0%, also not meeting the secondary target of 95%.Interventions that facilitated workflow had additional benefit beyond education alone to improve timing and rates of hepatitis B vaccine administration in both a university medical centre and community hospital nursery.

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.

Ataxia-telangiectasia-mutated (ATM) is a T-antigen kinase that controls SV40 viral replication in vivo.

The structurally related ATM (ataxia-telangiectasia-mutated) and ATR (ATM-Rad3-related) protein kinases fulfill overlapping yet non-redundant functions as key regulators of cellular DNA damage responses. We recently showed that ATM phosphorylates the cyclic AMP response element-binding protein, CREB, following exposure to ionizing radiation (IR) and other DNA-damaging stimuli. Here, we show that a phospho-specific antibody recognizing the major ATM phosphorylation site in CREB cross-reacts with SV40 large tumor antigen (LTag), a multifunctional oncoprotein required for replication of the SV40 minichromosome. The relevant IR-induced phosphorylation site in LTag recognized by phospho-CREB antibody was mapped to Ser-120. IR strongly induced the phosphorylation of Ser-120 in an ATM-dependent manner in mouse embryo fibroblasts. Infection of African green monkey CV1 cells with SV40 resulted in the activation of ATM and phosphorylation of LTag and endogenous ATM substrates. Infection-induced LTag phosphorylation correlated with the onset of DNA replication, was ATM-dependent, and peaked when viral DNA levels reached their maximum. SV40 replication in CV1 cells required an intact LTag Ser-120 phosphorylation site and was inhibited following transfection with ATM small interfering RNA suggesting that ATM is required for optimal SV40 replication in primate cells. Our findings uncover a direct link between ATM and SV40 LTag that may have implications for understanding the replication cycle of oncogenic polyoma viruses.

Inability of simian virus 40 to establish productive infection of lymphoblastic cell lines.

Lymphoblastic cell lines were infected with simian virus 40 (SV40) and then monitored for evidence of a productive infection. No evidence of early gene expression was found 2 days following infection, as determined by assaying viral mRNAs and early antigens. Furthermore, only small amounts of virus could be detected by plaque assay 2 days after infection, and levels slowly declined until they were undetectable after a few weeks in culture. Thus, human lymphocytes are not readily infectible with SV40 and do not provide a simple model for studying interactions of SV40 with a human cell type.