Pediatric Decision-Making: ethical aspects specific to neonates.

Recently published consensus recommendations on pediatric decision-making by Salter and colleagues (2023) did not address neonatal decision-making, due to the unique complexities of neonatal care. This essay explores three areas that impact neonatal decision-making: legal and policy considerations, rapid technological advancement, and the unique emotional burdens faced by parents and clinicians during the medical care of neonates. The authors evaluate the six consensus recommendations related to these considerations and conclude that the consensus recommendations apply to neonates.

The common trisomy syndromes, their cardiac implications, and ethical considerations in care.

PURPOSE OF REVIEW: To review the incidence of congenital heart disease in the trisomies, highlight the history of cardiac surgery in trisomy 21 comparing it to the increase in cardiac surgery in trisomies 13 and 18, discuss ethical issues specific to trisomies 13 and 18, and suggest a pathway of shared decision-making in the management of congenital heart disease in trisomy 13 and 18, specifically congenital heart surgery. RECENT FINDINGS: Congenital heart disease is prevalent in the trisomies and the management of these defects, especially surgical intervention, has changed. In the late 20th century, survival after cardiac surgery in trisomy 21 vastly improved, significantly decreasing morbidity and mortality secondary to pulmonary hypertension. Similarly, procedures and surgeries have been performed with increasing frequency in trisomy 13 and 18 patients and concomitantly, survival in this patient population is increasing. Yet across the United States, the willingness to perform cardiac surgery in trisomy 13 and 18 is variable, and there is ethical controversy about the correct action to take. To address this concern, a shared decision-making approach with an informed parent(s) is advised. SUMMARY: As the care and management of congenital heart disease changed in trisomy 21, so too it has with trisomy 13 and 18. Physicians and parents should develop goal-directed treatment plans balancing the risk versus benefit and consider cardiac surgical repair if feasible and beneficial.

Reflections on New Evidence on Crisis Standards of Care in the COVID-19 Pandemic.

Crisis standards of care have been widely developed by healthcare systems and states in the United States during the COVID-19 pandemic, and in some rare cases have actually been used to allocate medical resources. All publicly available U.S. crisis standards of care with a mechanism for allocating scarce resources make use of the Sequential Organ Failure Assessment (SOFA) score in hopes of assigning scarce resources to those patients who are more likely to survive. We reflect on the growing body of evidence suggesting that the SOFA score has limited accuracy in predicting mortality among patients hospitalized with COVID-19 and that the SOFA score systematically disfavors Black patients. Use of the SOFA score for allocating scarce resources may therefore result in Black patients with equal likelihood of survival being deprived of life-saving medical resources. There is also a risk of injustice for patients with non-COVID-19 diagnoses, for whom the SOFA score may be a more accurate prognostic score, but who might nevertheless be unfairly (de)prioritized when assessed alongside COVID-19 patients using the same scoring system. For these reasons we recommend that the SOFA score not be used for triage purposes during the COVID pandemic, and that a national effort be made to develop and empirically test crisis standards of care in advance of the next public health emergency.

Parents' Perspective on Trainees Performing Invasive Procedures: A Qualitative Evaluation.

OBJECTIVES: When obtaining informed permission from parents for invasive procedures, trainees and supervisors often do not disclose information about the trainee's level of experience. The objectives of this study were 3-fold: (1) to assess parents' understanding of both academic medical training and the role of the trainee and the supervisor, (2) to explore parents' preferences about transparency related to a trainee's experience, and (3) to examine parents' willingness to allow trainees to perform invasive procedures. METHODS: This qualitative study involved 23 one-on-one interviews with parents of infants younger than 30 days who had undergone a lumbar puncture. In line with grounded theory, researchers independently coded transcripts and then collectively refined codes and created themes. Data collection and analysis continued until thematic saturation was achieved. In addition, to triangulate the findings, a focus group was conducted with Yale School of Medicine's Community Bioethics Forum. RESULTS: Our analysis revealed 4 primary themes: (1) the invasive nature of a lumbar puncture and the vulnerability of the newborn creates fear in parents, which may be mitigated by improved communication; (2) parents have varying degrees of awareness of the medical training system; (3) most parents expect transparency about provider experience level and trust that a qualified provider will be performing the procedure; and (4) parents prefer an experienced provider to perform a procedure, but supervisor presence may be a qualifying factor for inexperienced providers. CONCLUSIONS: Physicians must find a way to improve transparency when caring for pediatric patients while still developing critical procedural skills.

Developing a Triage Protocol for the COVID-19 Pandemic: Allocating Scarce Medical Resources in a Public Health Emergency.

The coronavirus disease-2019 (COVID-19) has caused shortages of life-sustaining medical resources, and future waves of the virus may cause further scarcity. The Yale New Haven Health System developed a triage protocol to allocate scarce medical resources during the COVID-19 pandemic, with the primary goal of saving the most lives possible, and a secondary goal of making triage assessments and decisions consistent, transparent, and fair. We outline the process of developing the triage protocol, summarize the protocol itself, and discuss the major ethical challenges encountered, along with our answers to these challenges. These challenges include (1) the role of age and chronic comorbidities; (2) evaluating children and pregnant patients; (3) racial, ethnic, and socioeconomic disparities in health; (4) prioritization of healthcare workers; and (5) balancing clinical judgment versus protocolized assessments. We conclude with a review of the limitations of our protocol and the lessons learned. We hope that a robust public discussion of such protocols and the ethical challenges that they raise will result in the fairest possible processes, less need for triage, and more lives saved during future waves of the COVID-19 pandemic and similar public health emergencies.

Is Extracorporeal Membrane Oxygenation for a Neonate Ever Ethically Obligatory?

Certain interventions in the neonatal intensive care unit are considered ethically obligatory, and should be provided over parental objections. After reviewing a case, comparative outcome data, and relevant ethical principles, we propose that extracorporeal membrane oxygenation for meconium aspiration syndrome may, in some cases, be an ethically obligatory treatment.

The EXTEND system for extrauterine support of extremely premature neonates: opportunity and caution.

Investigators have recently described successful use of an EXTrauterine Environment for Neonatal Development (EXTEND), essentially an artificial womb, to maintain extremely premature fetal lambs ex utero for up to 4 weeks, supporting normal growth and development. The animals were maintained in a fluid environment (Biobag) while nutrition and gas exchange were supported via umbilical catheters and the use of an external membrane oxygenator. The lambs studied correspond to humans at 23-25 weeks' gestation, which is the target range for proposed clinical trials. This new technology offers the possibility of improving outcomes in a patient population with a high rate of mortality and morbidity. However, if safety and efficacy are adequately demonstrated in the lamb model, there remain important ethical considerations worthy of discussion prior to human trials. Moreover, the authors state there is no intention to use EXTEND on patients below the current limit of viability, but this possibility should nevertheless be considered, and should also be the subject of ethical discussion. Analysis of relevant ethical issues, including patient selection, moral status, rights, obligations, and others should precede use of this promising technology in humans.

Counselling variation among physicians regarding intestinal transplant for short bowel syndrome.

BACKGROUND: Intestinal transplant in infants with severe short bowel syndrome (SBS) is an emerging therapy, yet without sufficient long-term data or established guidelines, resulting in possible variation in practice. OBJECTIVES: To assess current attitudes and counselling practices among physicians regarding intestinal transplant in infants with SBS, and to determine whether counselling and management vary between subspecialists or centres. METHODS: A national sample of practicing paediatric surgeons and neonatologists was surveyed via the American Academy of Paediatrics listserves. Results were analysed by physician subspecialty and again by presence or absence of intestinal transplant at respondent's centre. RESULTS: The survey was completed by 433 respondents, consisting of 363 neonatologists and 70 paediatric surgeons. Fifty-seven respondents (13.2%) practiced at a centre that performed intestinal transplants in children. The vast majority of respondents (91% for preterm, 95% for term neonates) felt that maintaining a neonate with SBS on total parenteral nutrition for intestinal transplant was ethically optional (neither impermissible nor obligatory), and that parents should be given an informed choice whether to pursue that option. However, only 33% indicated they often/always offer intestinal transplant as a treatment option to families in this situation. CONCLUSIONS: There is a marked disparity between individual physicians' beliefs regarding the acceptability of intestinal transplant for severe SBS and their reported practice. Wide variability exists among physicians with respect to their knowledge, beliefs and practice regarding severe SBS, raising concerns about transparency and justice. Survival data prior to transplant, currently unavailable, are essential to rational decision making and informed parental permission.

Gestational Carrier Pregnancies: Legal and Ethical Considerations for Pediatricians.

This case explores the legal and ethical considerations for pediatricians surrounding gestational carrier pregnancies in the United States. Because of high success rates for assisted reproduction, state laws supporting same-sex adoption and surrogacy, and established legal precedents, gestational carrier pregnancies are increasingly common. The case presented involves a gestational carrier in preterm labor at 30 weeks' gestation with malpositioned twins who declines a cesarean delivery. Three commentaries are presented. The first highlights the importance of understanding the ethical implications of gestational carrier pregnancies in prenatal counseling. The second commentary emphasizes the pregnant person's right to autonomy and bodily integrity, and discusses considerations in surrogacy pregnancies, including the authority to authorize a cesarean delivery, valid informed consent, and decision-making for neonates. The third commentary discusses autonomy, emphasizing the importance of contracts in surrogacy pregnancies, and suggests that, in the case of a conflict between the gestational carrier and the intended parent(s), the gestational carrier's preference should be decisive regarding medical care during pregnancy. These discussions highlight key concepts for ethically informed and family-centered care in gestational carrier pregnancies and deliveries.

Ethics at the end of life in the newborn intensive care unit: Conversations and decisions.

The unexpected birth of a critically ill baby raises many ethical questions for neonatologists. Some of these are obviously ethical questions, about whether to attempt resuscitation, and, if the baby is resuscitated and survives, whether to continue life sustaining interventions. Other ethical decisions are more related to what to say rather than what to do. Although less obvious, they are equally as important, and may also have far-reaching ramifications. This essay presents the story of a newborn with profound hypoxic-ischemic encephalopathy, and reviews decisions regarding resuscitation, withdrawal of mechanical ventilation, withdrawal of medically administered nutrition and hydration, and active euthanasia. An overview of the ethical issues at work at each decision point is presented, as well as guidance regarding discussions with parents throughout the process, including specific wording. This may serve as a helpful guide for ethical deliberation, and helpful scripting for parental discussion, in similar cases.

Pediatricians' Reports of Interaction with Infant Formula Companies.

Introduction: Seventy percent of countries follow the World Health Organization International Code of Marketing Breast Milk Substitutes that prohibits infant formula companies (IFC) from providing free products to health care facilities, providing gifts to health care staff, or sponsoring meetings. The United States rejects this code, which may impact breastfeeding rates in certain areas. Objective: We aimed at gathering exploratory data about interactions between IFC and pediatricians. Methods: We distributed an electronic survey to U.S. pediatricians asking about practice demographics, interactions with IFC, and breastfeeding practices. Using the zip code of the practice, we obtained additional information from the 2018 American Communities Survey, including median income, percent of mothers who had graduated college, percent of mothers working, and racial and ethnic identity. We compared demographic data for those pediatricians who had a formula company representative visit versus not and those who had a sponsored meal versus not. Results: Of 200 participants, the majority reported a formula company representative visit to their clinic (85.5%) and receiving free formula samples (90%). Representatives were more likely to visit areas with higher-income patients (median = $100K versus $60K, p < 0.001). They tended to visit and sponsor meals for pediatricians at private practices and in suburban areas. Most of the reported conferences attended (64%) were formula company-sponsored. Conclusion: Interactions between IFC and pediatricians are prevalent and occur in many forms. Future studies may reveal whether these interactions influence the advice of pediatricians or the behavior of mothers who had planned to exclusively breastfeed.

Pediatric Decision Making: Consensus Recommendations.

Despite apparent disagreement in the scholarly literature on standards of pediatric decision making, a recognition that similar norms underpin many of the dominant frameworks motivated a June 2022 symposium "Best Interests and Beyond: Standards of Decision Making in Pediatrics" in St Louis, MO. Over the course of this 3-day symposium, 17 expert scholars (see author list) deliberated on the question "In the context of US pediatric care, what moral precepts ought to guide parents and clinicians in medical decision making for children?" The symposium and subsequent discussion generated 6 consensus recommendations for pediatric decision making, constructed with the primary goals of accessibility, teachability, and feasibility for practicing clinicians, parents, and legal guardians. In this article, we summarize these recommendations, including their justification, limitations, and remaining concerns.

The Case for Ethical Efficiency: A System That Has Run Out of Time.

The American health care system increasingly conflates physician "productivity" with true clinical efficiency. In reality, inordinate time pressure on physicians compromises quality of care, decreases patient satisfaction, increases clinician burnout, and costs the health care system a great deal in the long term even if it is financially expedient in the short term. Inadequate time to deliver care thereby conflicts with the core principles of biomedical ethics, including autonomy, beneficence, nonmaleficence, and justice. We propose that the health care system adjust its focus to recognize the nonmonetary value of physician time while still realizing the need to deploy resources as effectively as possible, a concept we describe as "ethical efficiency."

Ethical considerations in the use of artificial womb/placenta technology.

Despite improvements in survival over the past few decades, pulmonary immaturity and the use of mechanical ventilation have stunted reduction in short- and long-term morbidities for infants at the borderline of viability (22-24 weeks of gestation). It has long been suspected that the use of an artificial womb or artificial placenta to preserve native fetal physiology and maintain fluid- rather than air-filled lungs would help to improve outcomes for these infants. As such, several institutions have ongoing efforts to develop this technology, bringing the field of neonatology within sight of clinical trials. Prior to use in humans, several important ethical issues should be considered and discussed, including the moral status of these patients and the term used to describe them, whether neonate, fetus, or another term entirely. These determinations will guide when it is appropriate to use the technology and when it is permissible to withdraw this support, as well as how to ascribe parental rights and the legal status of these patients.

Neonatology's race to the bottom: RVUs, cFTEs, and physician time.

The clinical productivity of neonatology divisions is often defined as relative value units (RVUs) produced per clinical full-time equivalent physicians (cFTEs). Based on the realities of neonatology clinical billing, commonly daily bundled charges, and one cFTE defined as a fixed number of clinical hours per year, the RVU:cFTE ratio will inevitably be proportional to the number of NICU patients per physician clinical hour. As a result, increasing productivity defined as the RVU:cFTE ratio, a commonly incentivized goal in neonatology, requires decreasing physician time per patient. As neonatology groups seek to surpass RVU:cFTE benchmarks based upon productivity of peer institutions, they end up in a "race to the bottom," each striving to spend less time per patient than their peers. This definition of physician productivity fails to consider the importance of time itself as an essential "product" provided by physicians, and can undermine the clinical mission and quality of care.