Research Ethics in Pregnancy: The Maternal-Fetal Dyad.

Pregnant persons and their physicians often make decisions for health care without clinical evidence to guide their choices. Years of exclusionary practices in research, dominated by fears of fetal harm, have resulted in limited evidence on therapies for pregnancy-specific conditions. It has also eroded pregnant persons' rights as autonomous individuals capable of weighing risks and benefits to make choices for themselves and their infants based on sound evidence. A paradigm shift from "routine exclusion" to "fair inclusion" of pregnant persons in clinical trials is needed to ensure that ethical principles are upheld when undertaking research in this population. This article will provide a brief review of the historical aspects of clinical research ethics for pregnant persons, focus on some key concepts within the context of the maternal-fetal dyad, and include a recent example from the coronavirus disease 2019 (COVID-19) pandemic to understand how society has interpreted tensions among the ethical principles of justice, beneficence, nonmaleficence, and autonomy. Note: This review uses the term "pregnant person(s)" to include women and people who are pregnant and do not identify themselves as women.

Antenatal consultation and deliberation: adapting to parental preferences.

OBJECTIVE: To analyze and compare perspectives on antenatal consultation and decision-making from participants with varying degrees of prematurity experience and clinician-experts. STUDY DESIGN: Open-ended interviews structured around topics previously identified by recognized clinician-experts were conducted with participants having different levels of prematurity experience. Analysis used mixed methods (thematic and mental models analysis). Secondary sub-group comparisons were performed, based on degree of experience. RESULTS: Non-clinician participants' (n = 80) perspectives differed regarding: amount and content of information desired, decision-making strategies, and who - parent or clinician - should direct consultations. Most wanted to retain decisional authority, all recognized their emotional limitations and many advocated for deliberation support. Participants worried parents' would regret choosing palliative care contrary to clinicians. Bereaved parents often saw issues differently. CONCLUSIONS: Parents approach risk and decision-making for extremely premature infants in a personal fashion. They need personalized support tailored to their unique circumstances, decision-making preferences, and emotions.

Bereaved Parents: Insights for the Antenatal Consultation.

OBJECTIVE: The study aimed to explore experiences of extremely preterm infant loss in the delivery room and perspectives about antenatal consultation. STUDY DESIGN: Bereaved participants were interviewed, following a semi-structured protocol. Personal narratives were analyzed with a mixed-methods approach. RESULTS: In total, 13 participants, reflecting on 17 pregnancies, shared positive, healing and negative, harmful interactions with clinicians and institutions: feeling cared for or abandoned, doubted or believed, being treated rigidly or flexibly, and feeling that infant's life was valued or not. Participants stressed their need for personalized information, individualized approaches, and affective support. Their decision processes varied; some wanted different things for themselves than what they recommended for others. These interactions shaped their immediate experiences, long-term well-being, healing, and regrets. All had successful subsequent pregnancies; few returned to institutions where they felt poorly treated. CONCLUSION: Antenatal consultations can be strengthened by personalizing them, within a strong caregiver relationship and supportive institutional practices. KEY POINTS: · Personalized antenatal consultations should strive to balance cognitive and affective needs.. · Including perspectives from bereaved parents can strengthen antenatal consultations.. · Trusting provider-parent partnerships are pivotal for risk communication..

Personalized support of parents of extremely preterm infants before, during and after birth.

The emotional turmoil associated with extremely preterm birth is inescapable parents. How each parent handles the unexpected, makes sense of the unknown and learns to parent their child is uniquely personal. A rigid standardized approach to support families through their journey before and during neonatal intensive care disregards this individuality. This article reviews general concepts and practices that can be learned and applied by clinicians to promote resiliency and help parents cope adaptively. This review will describe how to personalize parenting support during the antenatal consultation and hospitalization for parents of extremely premature infants. To facilitate this, mindsets and care delivery models need to shift from inflexible standardized protocols to flexible guidelines that enable personalized communications, support structures and care delivery models tailored to each person's characteristics, preferences, and values.

Ethical considerations in the management of infants with severe intraventricular hemorrhage.

Intrinsic and extrinsic factors unique to neonatal care can complicate predictions of neurological outcomes for infants who suffer from severe intraventricular hemorrhage. While care decisions are driven by the same bioethical principles used in other domains, neurological prognostication can challenge concepts of futility, require careful examination of parental values, uncover biases and/or potentially compromise the best interests of the future child. In the following chapter we will review bioethical principles and relevant concepts, explore challenges to decision-making surrounding diagnoses of severe intraventricular hemorrhage and conclude with a brief review of practical approaches for counseling parents about neurodevelopmental impairment given the constraints of prognostic uncertainty and assumptions related to quality of life. We will argue that neurological findings alone, even in the setting of severe intraventricular hemorrhage, often do not constitute enough evidence for redirection of care but can be permissible when the entire neonatal condition is considered.

Personalized communication with parents of children born at less than 25 weeks: Moving from doctor-driven to parent-personalized discussions.

Communication with parents is an essential component of neonatal care. For extremely preterm infants born at less than 25 weeks, this process is complicated by the substantial risk of mortality or major morbidity. For some babies with specific prognostic factors, the majority die. Although many of these deaths occur after admission to the intensive care unit, position statements have focused on communication during the prenatal consultation. This review takes a more comprehensive approach and covers personalized and parent-centered communication in the clinical setting during three distinct yet inter-related phases: the antenatal consultation, the neonatal intensive care hospitalization, and the dying process (when this happens). We advocate that a 'one-size-fits-all' communication model focused on standardizing information does not lead to partnerships. It is possible to standardize personalized approaches that recognize and adapt to parental heterogeneity. This can help clinicians and parents build effective partnerships of trust and affective support to engage in personalized decision-making. These practices begin with self-reflection on the part of the clinician and continue with practical frameworks and stepwise approaches supporting personalization and parent-centered communication.

Optimism bias in understanding neonatal prognoses.

OBJECTIVE: Discrepancies between physician and parent neonatal prognostic expectations are common. Optimism bias is a possible explanation. STUDY DESIGN: Parents interpreted hypothetical neonatal prognoses in an online survey. RESULTS: Good prognoses tended to be interpreted accurately, while poor prognoses were interpreted as less than the stated value. One-third of participants consistently overstated survival for the three lowest prognoses, compared to the sample as a whole. Three significant predictors of such optimistic interpretations were single-parent status (OR 0.39; 95% CI 0.2-0.75; p = 0.005), African-American descent (OR 3.78; 95% CI 1.63-8.98; p = 0.002) and the belief that physicians misrepresented prognoses (OR 3.11; 95% CI 1.47-6.65; p = 0.003). Participants' explanations echoed research on optimism bias in clinical and decision science studies. CONCLUSION: Participants accepted positive prognoses for critically ill neonates, but reinterpreted negative ones as being unduly pessimistic demonstrating optimism bias.

Should Extremely Premature Babies Get Ventilators During the COVID-19 Crisis?

In a crisis, societal needs take precedence over a patient's best interests. Triage guidelines, however, differ on whether limited resources should focus on maximizing lives or life-years. Choosing between these two approaches has implications for neonatology. Neonatal units have ventilators, some adaptable for adults. This raises the question of whether, in crisis conditions, guidelines for treating extremely premature babies should be altered to free-up ventilators. Some adults who need ventilators will have a survival rate higher than some extremely premature babies. But surviving babies will likely live longer, maximizing life-years. Empiric evidence demonstrates that these babies can derive significant survival benefits from ventilation when compared to adults. When "triaging" or choosing between patients, justice demands fair guidelines. Premature babies do not deserve special consideration; they deserve equal consideration. Solidarity is crucial but must consider needs specific to patient populations and avoid biases against people with disabilities and extremely premature babies.

Helping Parents Cope in the NICU.

Parenting in the NICU is an intense journey. Parents struggle to build intimacy with their child amid complex emotions and medical uncertainties. They need to rapidly adapt their vision of parenthood to the realities of intensive care. The psychological impact of this journey can have important effects on their psychological health. For parents of sick older children, "good parent" beliefs have been shown to foster positive growth. This concept is also essential for parents of infants in the NICU, although their path is complex.We write as clinicians who were also families in the NICU. We suggest parents need to hear and internalize 3 important messages that overlap but are each important: you are a parent, you are not a bad parent, and you are a good parent. We offer practical suggestions to NICU clinicians that we believe will help NICU parents cope while their infant is in the NICU and afterward.

Counseling parents at risk of delivery of an extremely premature infant: Differing strategies.

BACKGROUND: It is not known how neonatologists address the affective and cognitive loads on parents deciding whether to resuscitate infants born extremely preterm. This study explores expert neonatologists' views on these decision-making processes and their own roles in counseling parents. METHODS: Semistructured interviews asked internationally recognized experts to share their perspectives on perinatal consultations. Their responses were subjected to thematic analysis. RESULTS: Eighteen of 22 invited experts participated. Approximately equal numbers reported employing a physician-driven approach, a parent-driven approach, and a combined approach during these consultations. Those who followed a physician-driven approach typically focused on conveying standard information about adverse outcomes. Those who followed a parent-driven approach typically focused on addressing parents' information requests, guiding their decision making, and providing affective support. Nearly all experts, in each group, endorsed addressing the child's quality of life, in terms of functionality, when discussing long-term outcomes. Although many believed that families adjusted to life with a disabled child, few discussed the topic during prenatal consultations. Most, in each group, reported trying to alleviate future "decisional regret" for parents whose premature infants subsequently became disabled. None spoke to parents about possible decisional regret after deciding to forgo resuscitation. CONCLUSIONS: Expert neonatologists are deeply concerned that parents understand the decision facing them. However, they differ on what information they offer and how they balance parents' need for cognitive and affective support. They expressed more concern about parents' decisional regret should their child survive resuscitation, but have severe disability, than about decisional regret after foregoing resuscitation.

Personalized Decision Making: Practical Recommendations for Antenatal Counseling for Fragile Neonates.

Emphasis has been placed on engaging parents in processes of shared decision making for delivery room management decisions of critically ill neonates whose outcomes are uncertain and unpredictable. The goal of antenatal consultation should rather be to adapt to parental needs and empower them through a personalized decision-making process. This can be done by acknowledging individuality and diversity while respecting the best interests of neonates. The goal is for parents to feel like they have agency and ability and are good parents, before birth, at birth, and after, either in the NICU or until the death of their child.

Stronger and More Vulnerable: A Balanced View of the Impacts of the NICU Experience on Parents.

For parents, the experience of having an infant in the NICU is often psychologically traumatic. No parent can be fully prepared for the extreme stress and range of emotions of caring for a critically ill newborn. As health care providers familiar with the NICU, we thought that we understood the impact of the NICU on parents. But we were not prepared to see the children in our own families as NICU patients. Here are some of the lessons our NICU experience has taught us. We offer these lessons in the hope of helping health professionals consider a balanced view of the NICU's impact on families.

An introduction to behavioural decision-making theories for paediatricians.

UNLABELLED: Behavioural decision-making theories provide insights into how people make choices under conditions of uncertainty. However, few have been studied in paediatrics. This study introduces these theories, reviews current research and makes recommendations for their application within the context of shared decision-making. CONCLUSION: As parents are expected to share decision-making in paediatrics, it is critical that the fields of behavioural economics, communication and decision sciences merge with paediatric clinical ethics to optimise decision-making.