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.).

Determinants of Length of Stay after Neonatal Cardiac Surgery Using Path Analysis.

After neonatal cardiac surgery, families, and the health care team strive for exclusive oral feedings before hospital discharge. With the hypothesis that exclusive oral feedings would reduce the length of stay (LOS), a multidimensional path analysis was used to examine a cross-section of 280 neonates from 2009 to 2013. Buttigieg, Abela, and Pace's theoretical framework of structural and process-related determinants of LOS was modeled with hypothesis-driven correlation and directionality. The recursive path model had a good global and local fit with outcome variances of 26% for exclusive oral feeding and LOS. In the full cohort and model groups (single and biventricular), when controlling for covariances: sepsis, birth distance, necrotizing enterocolitis, genetic differences, specialty consults, the age at which neonatal cardiac surgery occurred (ß = .23, p ≤ .001) and the duration of postoperative intubation (ß = .47, p ≤ .001) more significantly influenced the LOS than intermediate mediation of exclusive oral feedings at discharge.

Medical and surgical interventions and outcomes for infants with trisomy 18 (T18) or trisomy 13 (T13) at children's hospitals neonatal intensive care units (NICUs).

OBJECTIVES: To examine characteristics and outcomes of T18 and T13 infants receiving intensive surgical and medical treatment compared to those receiving non-intensive treatment in NICUs. STUDY DESIGN: Retrospective cohort of infants in the Children's Hospitals National Consortium (CHNC) from 2010 to 2016 categorized into three groups by treatment received: surgical, intensive medical, or non-intensive. RESULTS: Among 467 infants admitted, 62% received intensive medical treatment; 27% received surgical treatment. The most common surgery was a gastrostomy tube. Survival in infants who received surgeries was 51%; intensive medical treatment was 30%, and non-intensive treatment was 72%. Infants receiving surgeries spent more time in the NICU and were more likely to receive oxygen and feeding support at discharge. CONCLUSIONS: Infants with T13 or T18 at CHNC NICUs represent a select group for whom parents may have desired more intensive treatment. Survival to NICU discharge was possible, and surviving infants had a longer hospital stay and needed more discharge supports.

Inter-center variation in autopsy practices among regional neonatal intensive care units (NICUs).

OBJECTIVE: To characterize infants who underwent autopsy in regional neonatal intensive care units (NICUs) and examine inter-center variability in autopsy completion. STUDY DESIGN: Retrospective cohort study of infants who died between 2010 and 2016 from 32 participating hospitals in the Children's Hospital Neonatal Database (CHND). Maternal/infant demographics and hospital stay data were collected, along with autopsy rates by center, year, and region. Data analysis utilized bivariate and multivariable statistics. RESULT: Of 6299 deaths, 1742 (27.7%) completed autopsy. Infants who underwent autopsy had higher median birth weight (2 124 g vs. 1 655 g) and gestational age (34 vs. 32 weeks). No differences were seen in sex, length of stay, or primary cause of death. Marked inter-center variability was observed, with 17-fold adjusted difference (p < 0.001) in autopsy rates. CONCLUSION: Patient characteristics do not account for variability in autopsy practices across regional NICUs. Factors such as provider practices and parental preferences should be investigated.

Implementation of the Neonatal Sepsis Calculator in Early-Onset Sepsis and Maternal Chorioamnionitis.

BACKGROUND: Utilization of the neonatal sepsis calculator published by Kaiser Permanente is rapidly increasing. This freely available online tool can be used in assessment of early-onset sepsis (EOS) in newborns 34 weeks' gestation or more based on maternal risk factors and neonatal examination. However, many hospitals lack standard guidelines for its use, leading to provider discomfort with practice change. PURPOSE: The goal of this project was to study the antibiotic use rate for EOS at a level III neonatal intensive care unit and create standardized guidelines and staff education for using the sepsis calculator. Our ultimate goal was to decrease antibiotic use for EOS in newborns 34 weeks' gestation or more. METHODS: A standard quality improvement Plan-Do-Study-Act (PDSA) model was utilized with a plan to study the problem, implement the intervention, and test again for improvement. The primary outcome of interest was a decrease in the use of antibiotics for EOS in neonates 34 weeks' gestation or more. RESULTS: Over a 4-month period, prior to sepsis calculator implementation, antibiotic use for suspected EOS was 11% and blood culture was done on 14.8% of live births. After implementation of the sepsis calculator and completion of the PDSA cycle, sepsis calculator use was greater than 95%, antibiotic use dropped significantly to 5% (P = .00069), and blood culture use dropped to 7.6% (P = .00046). IMPLICATIONS FOR PRACTICE: Staff education and systematic intervention using a PDSA model can significantly impact patient care, decreasing the administration of antibiotics to infants at risk for sepsis. IMPLICATIONS FOR RESEARCH: Future research is needed to decrease antibiotic use in premature infants less than 34 weeks' gestation with similar risk factors and clinical features.Video Abstract available at https://journals.na.lww.com/advancesinneonatalcare/Pages/videogallery.aspx?videoId=34&autoPlay=true.

Neonatal respiratory extracorporeal membrane oxygenation and primary diagnosis: trends between two decades.

OBJECTIVE: Examine changing neonatal respiratory extracorporeal membrane oxygenation (ECMO) practice trends and outcomes. STUDY DESIGN: Retrospective cohort study comparing neonatal respiratory ECMO in the 1990 and 2010 decades (1994-1995 and 2014-2015). Patients ≤ 30 days of life, reported to the Extracorporeal Life Support Organization registry, were included. RESULTS: Four thousand one hundred and twenty-five patients met inclusion criteria. ECMO cases decreased by 33%. The primary ECMO diagnosis changed significantly over time (p < 0.0001). Survival to discharge decreased (76 vs 67%, p < 0.0001) and ECMO duration increased (131 vs 158 h, p < 0.001). Lung recovery was the most common reason to discontinue ECMO although family request for withdrawal and a diagnosis considered "incompatible with life" was increasingly common in the 2010s. CONCLUSION: Although the use of ECMO for neonatal respiratory diagnoses has decreased over time, its use has increased for patients with more complex diagnoses and ECMO duration is longer. ECMO continues to be an important supportive therapy, improved understanding of which patients would benefit most is needed.

Infants of borderline viability: the ethics of delivery room care.

For more than half a century neonatologists and ethicists alike have struggled with ethical dilemmas surrounding infants born at the limits of viability. Both doctors and parents face difficult decisions. Do we try to save these babies, knowing that such efforts are likely to be unsuccessful? Or do we provide only comfort care, knowing that, in doing so, you will inevitably allow some babies to die who might have been saved? In this paper, we review the outcome data on these babies and offer ten suggestions for doctors: (1) accept that there is a 'gray zone' during which decisions are not black and white; (2) do not place too much emphasis on gestational age; (3) dying is generally not in an infant's best interest; (4) impairment does not necessarily equal poor quality of life; (5) just because the train has left the station doesn't mean you can't get off; (6) respect powerful emotions; (7) be aware of the self-fulfilling prophecies; (8) time lag likely skews all outcome data; (9) statistics can be both confused and confusing; (10) never abandon parents.

Two neonates with congenital hydrocolpos.

Introduction. Neonatal hydrocolpos is a rare condition. Hydrocolpos is cystic dilatation of the vagina with fluid accumulation due to a combination of stimulation of secretary glands of the reproductive tract and vaginal obstruction. The differential for a neonatal presentation of lower abdominal mass includes urogenital anomalies, Hirschsprung's, disease or sacrococcygeal teratoma. Prenatal diagnosis and early newborn imaging studies leads to early detection and treatment of these cases. Case. We report here two cases of neonatal hydrocolpos with prenatal diagnosis of lower abdominal mass. Postnatally, ultrasound, MRI imaging, and cystoscopy confirmed large cystic mass as hydrocolpos with distal vaginal obstruction. Both patients had enlarged renal system secondary to mass effect. Conclusion. High index of suspicion for hydrocolpos in a newborn presenting with fetal diagnosis of infraumbilical abdominal mass will facilitate timely intervention and prevention of complications.

The neonatal autopsy: can it be revived?

OBJECTIVES: To describe the trend and factors associated with the autopsy over the past decade at a level III neonatal intensive care unit (NICU) where all patients are presented with an option. STUDY DESIGN: Retrospective study of the autopsy in a cohort of infants who died in the NICU from January 1, 2001, to December 31, 2010. RESULTS: Of 446 deaths, 33.9% received the autopsy and rates decreased from the 2 years prior to the study. The autopsy was associated with gestational age at birth and chronologic age at death. On multivariable logistic regression analyses, the odds of an autopsy increased with gestational age (p = 0.001), death in the postneonatal period (odds ratio [OR] = 2.01, 95% confidence interval [CI] = 1.28, 3.16), and absence of a major congenital anomaly (OR = 1.96, 95% CI = 1.22, 3.23). CONCLUSION: Autopsy rates continue to decline despite ensuring that all parents are presented with the option. Infants born at term and those who die after 1 month without known congenital anomalies are most likely to receive the autopsy. The persistently low rates may highlight the importance of helping families understand that the autopsy has utility even when the cause of death may appear to be obvious.

How infants die in the neonatal intensive care unit: trends from 1999 through 2008.

OBJECTIVE: To determine whether trends toward decreasing use of cardiopulmonary resuscitation at the time of death and increasing frequency of forgoing life-sustaining treatment had continued, as few studies quantifying mode of death for hospitalized infants have been conducted in the last 10 years. DESIGN: Retrospective descriptive study. SETTING: Regional referral neonatal intensive care unit. PARTICIPANTS: Infants who died from January 1, 1999, to December 31, 2008. Infants were categorized into following categories: (1) very preterm (≤32 weeks' gestation); (2) congenital anomaly; and (3) other. MAIN OUTCOME MEASURES: The primary outcome was level of clinical service provided at the end of life (care withheld, care withdrawn, or full resuscitation). RESULTS: For 10 years, 414 neonatal patients died. Of these, 61.6% had care withdrawn, 20.8% had care withheld, and 17.6% received cardiopulmonary resuscitation. The percentage of deaths that followed withholding of treatment rose by 1% per year (P = .01). Most of this change was accounted for by withholding of therapy in the very premature group. CONCLUSION: During the 10-year period, the primary mode of death in this regional referral neonatal intensive care unit was withdrawal of life-sustaining support. When death is imminent or medical care is considered futile, the approach is thought to provide a peaceful, controlled setting. Significant increase in withholding of care suggests improved recognition of medical futility and desire to provide a peaceful death.