Deliveries at extreme prematurity: outcomes, approaches, institutional variation, and uncertainty.

PURPOSE OF REVIEW: Medical decision making and practices surrounding extremely premature birth remains challenging for parents and care providers alike. Recently, concerns have been raised regarding wide practice variation, selection bias, and the limitations of outcomes data in this population. The purpose of this review is to summarize the recent literature relevant to deliveries at extreme prematurity with a focus on outcomes, approaches, and institutional variation. RECENT FINDINGS: Newer data suggest that evidence-based clinical guidelines and protocols for both pregnant women and infants at extreme prematurity are emerging and may improve care and outcomes at lower gestational ages. It has also been recently shown that wide practice variation, selection bias, and methodological limitations of outcomes data reporting with respect to deliveries at extreme prematurity exist. SUMMARY: Counseling at extreme prematurity should prioritize eliciting parental values and preferences with the goal of personalized shared decision-making. Providers should recognize limitations in counseling families at extreme prematurity, including selection bias, institutional variation, outcomes inaccuracies, prognostic uncertainty, and implicit biases. Standardized reporting of perinatal outcomes should be developed to help alleviate current outcomes misrepresentations and improve counseling at extreme prematurity. Education for providers in advanced communication skills is needed when counseling at extreme prematurity.

Assessing Ethics Knowledge: Development of a Test of Ethics Knowledge in Neonatology.

OBJECTIVE: To develop and validate the Test of Ethics Knowledge in Neonatology (TEK-Neo) with good internal consistency reliability, item performance, and construct validity that reliably assesses interprofessional staff and trainee knowledge of neonatal ethics. STUDY DESIGN: We adapted a published test of ethics knowledge for use in neonatology. The novel instrument had 46 true/false questions distributed among 7 domains of neonatal ethics: ethical principles, professionalism, genetic testing, beginning of life/viability, end of life, informed permission/decision making, and research ethics. Content and correct answers were derived from published statements and guidelines. We administered the voluntary, anonymous test via e-mailed link to 103 participants, including medical students, neonatology fellows, neonatologists, neonatology nurses, and pediatric ethicists. After item reduction, we examined psychometric properties of the resulting 36-item test and assessed overall sample performance. RESULTS: The overall response rate was 27% (103 of 380). The test demonstrated good internal reliability (Cronbach α = 0.66), with a mean score of 28.5 ± 3.4 out of the maximum 36. Participants with formal ethics training performed better than those without (30.3 ± 2.9 vs 28.1 ± 3.5; P = .01). Performance improved significantly with higher levels of medical/ethical training among the 5 groups: medical students, 25.9 ± 3.7; neonatal nurses/practitioners, 27.7 ± 2.7; neonatologists, 28.8 ± 3.7; neonatology fellows, 29.8 ± 2.9; and clinical ethicists, 33.0 ± 1.9 (P < .0001). CONCLUSIONS: The TEK-Neo reliably assesses knowledge of neonatal ethics among interprofessional staff and trainees in neonatology. This novel tool discriminates between learners with different levels of expertise and can be used interprofessionally to assess individual and group performance, track milestone progression, and address curricular gaps in neonatal ethics.

Do-Not-Resuscitate Orders in the Neonatal ICU: Experiences and Beliefs Among Staff.

OBJECTIVES: Studies in adult patients have shown that do-not-resuscitate orders are often associated with decreased medical intervention. In neonatology, this phenomenon has not been investigated, and how do-not-resuscitate orders potentially affect clinical care is unknown. DESIGN: Retrospective medical record data review and staff survey responses about neonatal ICU do-not-resuscitate orders. SETTING: Four academic neonatal ICUs. SUBJECTS: Clinical staff members working in each neonatal ICU. INTERVENTIONS: Survey response collection and analysis. MEASUREMENTS AND MAIN RESULTS: Participating neonatal ICUs had 14-48 beds and 120-870 admissions/yr. Frequency range of do-not-resuscitate orders was 3-11 per year. Two-hundred fifty-seven surveys were completed (46% response). Fifty-nine percent of respondents were nurses; 20% were physicians. Over the 5-year period, 44% and 17% had discussed a do-not-resuscitate order one to five times and greater than or equal to 6 times, respectively. Fifty-seven percent and 22% had cared for one to five and greater than or equal to 6 patients with do-not-resuscitate orders, respectively. Neonatologists, trainees, and nurse practitioners were more likely to report receiving training in discussing do-not-resuscitate orders or caring for such patients compared with registered nurses and respiratory therapists (p < 0.001). Forty-one percent of respondents reported caring for an infant in whom interventions had been withheld after a do-not-resuscitate order had been placed without discussing the specific withholding with the family. Twenty-seven percent had taken care of an infant in whom interventions had been withdrawn under the same circumstances. Participants with previous experiences withholding or withdrawing interventions were more likely to agree that these actions are appropriate (p < 0.001). CONCLUSIONS: Most neonatal ICU staff report experience with do-not-resuscitate orders; however, many, particularly nurses and respiratory therapists, report no training in this area. Variable beliefs with respect to withholding and withdrawing care for patients with do-not-resuscitate orders exist among staff. Because neonatal ICU patients with do-not-resuscitate orders may ultimately survive, withholding or withdrawing interventions may have long-lasting effects, which may or may not coincide with familial intentions.

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.

Lowering the Age of Consent for Vaccination to Promote Pediatric Vaccination: It's Worth a Shot.

This paper challenges historically preconceived notions surrounding a minor's ability to make medical decisions, arguing that federal health law should be reformed to allow minors with capacity as young as age 12 to consent to their own Centers for Diseases Control and Prevention (CDC)-approved COVID-19 vaccinations. This proposal aligns with and expands upon current exceptions to limitations on adolescent decision-making. This analysis reviews the historic and current anti-vaccination sentiment, examines legal precedence and rationale, outlines supporting ethical arguments regarding adolescent decision-making, and offers rebuttals to anticipated ethical counterarguments.

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.

Decision making at extreme prematurity: Innovation in clinician education.

Decision-making at extreme prematurity remains ethically and practically challenging and can result in parental and clinician distress. It is vital that clinicians learn the necessary skills integral to counseling and decision-making with families in these situations. A pedagogical approach to teaching counseling should incorporate adult learning theory, emphasize multidisciplinary team in-situ simulation that links to counseling clinicians' daily practice, and includes critical reflection, debriefing, and program assessment. Multiple educational strategies that train clinicians in advanced communication and decision-making offer promising results to optimize antenatal counseling and shared decision-making for families facing possible delivery at extreme prematurity. Continued process evaluation and innovation in these educational domains are needed while also assessing the effect on patient-centered outcomes.

Moral equivalence theory in neonatology.

This article explores the ethical concept of "the equivalence thesis" (ET), or the idea that withdrawing and withholding life sustaining treatments are morally equivalent practices, within neonatology. We review the historical origins, theory, and clinical rationale behind ET, and provide an analysis of how ET relates to literature that describes neonatal mode of death and healthcare professional and parent attitudes towards end-of-life care. While ET may serve as an ethical tool to optimize resource allocation in theory, its clinical utility is limited given the complexity of end-of-life care decisions.

Pediatric Shared Decision-Making for Simple and Complex Decisions: Findings From a Delphi Panel.

OBJECTIVE: To develop recommendations for pediatric shared decision-making (SDM). METHODS: We conducted a Delphi method study from 2020 to 2021 with an international panel (n = 21) of clinicians, researchers, and parents with expertise in pediatric SDM. We conducted semistructured interviews to identify the key processes of pediatric SDM. We coded the interviews using content analysis and developed a questionnaire on the potential processes of pediatric SDM. Using a Likert scale, panelists evaluated each process twice, once for simple decisions and once for complex decisions. Panelists were provided with a summary of the results and evaluated each process again. The processes that were agreed on for simple and complex decisions were reported as "fundamental processes." The processes that were agreed on for complex decisions were reported as "additional processes." RESULTS: A total of 79 recommendations were developed, including 29 fundamental processes and 14 additional processes for complex decisions. A recurring theme was the importance of personalizing the decision-making process. For example, the panel recommended that physicians should assess the family and child's desired roles in the decision-making process, assess their desired level of directiveness, and elicit and clarify their values, preferences, and goals. The panel also disagreed on several subprocesses, such as how to determine the child's role and the appropriate level of directiveness. CONCLUSIONS: An international expert panel developed recommendations for pediatric SDM for both simple and complex decisions. The recommendations highlight the importance of personalizing the decision-making process.

Critical decision-making in neonatology and pediatrics: the I-P-O framework.

Critical decision-making in neonatology and other areas of pediatrics often carries with it a complex and difficult ethical component. For any treatment under consideration, the impermissible-permissible-obligatory (I-P-O) spectrum provides a useful framework for determining how to proceed. Any proposed treatment can be located along this spectrum, and identified as either ethically impermissible, permissible, or obligatory. Treatments determined to be ethically impermissible should not be made available by physicians. Those deemed ethically permissible should be explained to parents, commonly with a specific recommendation. Informed parents should then be free to choose from among permissible options. Potential treatments deemed ethically obligatory should be provided to the patient, even in the face of parental objection. The fundamental ethical work in neonatology and pediatrics is determining where on the I-P-O spectrum a treatment under consideration should be located. This should be determined by the prognosis for the patient with and without the treatment, the feasibility of providing the treatment, and consideration of all relevant rights and obligations. Location on the line is dynamic, and clinicians should be open to movement of a given treatment along the spectrum as new information, particularly regarding effectiveness, toxicity, and/or alternatives, becomes available. This framework provides a structure for ethical conversation and decision-making related to a specific patient, as well as in the formation of institutional and national guidelines.

Gene and Stem Cell Therapies for Fetal Care: A Review.

Importance: Gene and stem cell therapies have become viable therapeutic options for many postnatal disorders. For select conditions, prenatal application would provide improved outcomes. The fetal state allows for several theoretical advantages over postnatal therapy, including immune immaturity and cellular niche accessibility. Observations: Advances in prenatal diagnostic accuracy and surgical precision, as well as improvements in stem cell and gene therapy methods, have made prenatal gene and stem cell therapy realistic. Studies in mouse models and early human trials demonstrate the feasibility of these approaches. Additional efforts are under way to streamline fetal applications of stem cell and gene therapy while carefully considering best ethical practice and following established regulatory pathways. Conclusions and Relevance: Fetal stem cell and gene therapy bring important therapeutic opportunities for select disorders that present in the fetal and neonatal periods. While this field is in its infancy, these therapies are starting to be available clinically, and clinicians should be aware of their benefits and challenges.

Variable management strategies for NEC totalis: a national survey.

BACKGROUND/OBJECTIVES: Necrotizing enterocolitis (NEC) is a serious disease linked to prematurity. A variant, NEC totalis, is associated with nearly 100% mortality. There is wide variation in counseling practices for NEC totalis. Our objectives are to determine what treatment options, if any, are offered to families, and which factors influence these decisions. METHODS: An anonymous survey was distributed to members of the AAP Sections on Neonatal-Perinatal Medicine and Pediatric Surgery. Data were analyzed utilizing chi-square tests and Spearman correlations, where applicable. RESULTS: In the setting of NEC totalis, 90% of the 378 respondents viewed offering life-sustaining interventions (LSI) as ethically permissible and 87% felt that transfer to another center willing to provide LSI should be considered; however, only 43% reported offering LSI to families. CONCLUSIONS: Management of NEC totalis remains challenging and significant practice variability persists. Most respondents do not offer ongoing medical/surgical management, despite believing it is an ethically permissible option.

On Being Fired: When Patients or Their Parents Fire Their Physician.

Wait, what? I've been fired?" I repeated, in the middle of morning rounds in the neonatal intensive care unit. Finally, the nurse who was taking care of our patient, Angela, responded, "Her parents fired you last night. They've already called Patient Relations. They want a new doctor." My heart sank. Only days into my block of service time as the attending physician in the NICU and I was fired, axed, canned, rejected by a family. How could this have happened? On my first day of service, I had introduced myself to Angela's parents, and I had then met with them daily to review results and the plan and to answer their questions. I thought we had connected well. I thought I had done everything right. I thought they trusted me to care for their daughter.

Teaching and assessing ethics in the newborn ICU.

Ethics and professionalism education has become increasingly recognized as important and incorporated into graduate medical education. However, such education has remained largely unstructured and understudied in neonatology. Neonatal-perinatal fellowship training programs have generally grappled with how best to teach and assess ethics and professionalism knowledge, skills, and behavior in clinical practice, particularly in light of accreditation requirements, milestones, and competencies. This article reviews currently available teaching methods, pedagogy, and resources in medical ethics, professionalism, and communication, as well as assessment strategies and tools, to help medical educators and practicing clinicians ensure trainees achieve and maintain competency. The need for consensus and future research in these domains is also highlighted.

Should Neonatologists Give Opinions Withdrawing Life-sustaining Treatment?

An infant has a massive intracranial hemorrhage. She is neurologically devastated and ventilator-dependent. The prognosis for pulmonary or neurologic recovery is bleak. The physicians and parents face a choice: withdraw the ventilator and allow her to die or perform a tracheotomy? The parents cling to hope for recovery. The physician must decide how blunt to be in communicating his own opinions and recommendations. Should the physician try to give just the facts? Or should he also make a recommendation based on his own values? In this article, experts in neonatology, decision-making, and bioethics discuss this situation and the choice that the physician faces.