Abstract
In the realm of clinical ethics as well as in health policy and organizational ethics, the onus of our work as ethicists is to optimize the medical care and experience of the patient to better target ethical dilemmas that develop in the course of care delivery. The role of ethics is critical in all aspects of medicine, but particularly so in the difficult and often challenging cases that arise in the care of pregnant women and newborns. One exemplary situation is that when a pregnant woman and her partner consider neonatal organ donation after receiving news of a terminal diagnosis and expected death of the newborn. While a newer, less practiced form of organ donation, this approach is gaining greater visibility as an option for parents facing this terminal outcome. The aim of our paper is to highlight some of the key ethical issues associated with neonatal organ donation and identify clinical and logistical aspects of implementing such an approach to facilitate organ donation.
Keywords
Abbreviations
United Network for Organ Sharing
Donation after Circulatory determination of Death
Donation after Neurologic determination of death
Organ Procurement Organizations
Center for Medicare and Medicaid
Introduction
Organ transplants have become an accepted surgical approach for the management of end-organ failure. Yet, there is an ongoing issue of scarce resource allocation as a way to bridge the supply-demand gap to meet the needs of patients who would benefit from transplant. Currently almost 700 children from birth to 5 years of age are waiting for a transplanted organ to improve their chances at health by United Network for Organ Sharing (UNOS) registry counts [1]. Infants, in particular, are at higher risk of wait-list mortality due to size limitations and lack of organ availability [2], with approximately 100 children under one year of age on the national organ wait-lists currently [3].
While robust strategies to increase adult donors are needed, there is also a concurrent need to increase donations to benefit wait-listed children. Neonatal donations may be one way to partially bridge the gap between demand and supply of organs suitable for transplant such as hearts, kidneys, livers, intestine, lungs and pancreas. Neonatal donations, as we define them here, are donations from children under one year of age with a terminal diagnosis, specificallyfollowing circulatory determination of death (DCDD) or neurological determination of death (DND) provided donors are above a minimum weight limit [2 , 5]. While we appreciate that neonatal donations would customarily be defined as donations occurring <28 days of life, the data provided by UNOS only records donations from birth up to 1 year of age, thereby including both neonatal and infant donations within one category. We recognize that some infant donations occur due to later death from congenital conditions, but that many are from new onset conditions such as severe infection or SIDS and therefore are distinct from neonatal donations. Mainly the thrust of our arguments for this paper are related to neonatal donations, even though there is limited data on true neonatal donations published. This highlights the need for conceptual but even more essentially, empirical work in this area.
Diagnostic indications for possible neonatal donation, as explained by Hanley et al. [4] could include in utero determined terminal fetal diagnosis such as anencephaly, or anticipated DCDD or DND from prenatal diagnosis or neonatal diagnosis/ health conditions such as complex congenital cardiac disease, inborn errors of metabolism, respiratory failure due to lung pathology and unexpected DCDD or DND from a traumatic accident. Historically in the US, donations performed when the donor is under one year of age have been in the range of ∼100–150 annually for the last twelve years for all organs, from 2005 to present [6]. Currently for 2018, 56 donations have occurred where the donor has been less than 1 year of age [6].
This is a small subset of the collective 1000 or so deceased donations each year where donors are 17 or younger, signifying that nationally widespread clinical experience is lacking with donors of this age group leading to a mirroring dearth of data and reports on successful outcomes from transplants of such organs, an aspect we recommend that more research as well as data collection and broader data sharing can help bridge this gap (see Table 1). In looking at donations under 1 and up to 1 year of age in 2017 alone, 108 infants donated after DND, and there were only 15 donations after DCDD [6], mirroring the historic trend of pediatric DCDD being underutilized in the U.S. broadly, as illustrated by studies at Children’s Hospital of Philadelphia [7] and at University of Utah [2]. For 2017 however, these donations led to 245 transplants where the donor was younger than a year old [6]. Hereafter in this article, since we are primarily talking about donation up until 1 year of age, we will describe this as neonatal donation, given that this is how this cohort of donors is categorized in available data.
Pros and cons of providing neonatal donations protocol at an institution
Pros and cons of providing neonatal donations protocol at an institution
Additionally, the question of whether neonatal donation is even medically feasible is a decision that can only be made after the birth of the infant, though indications of this may be identified prenatally. Although clinically there may be a prospective understanding of the outcome for the neonate, the mere experience of maternal and paternal bonding with the pregnancy and loss/grief from the loss of their ideas of what the pregnancy and their family would be is an important factor that should shape the ethics of neonatal donation. For some parents, news of a suspected terminal diagnosis may be introduced during pregnancy, giving them time to contemplate this option while, at the same time, considering their family and reproductive choices in the context of often high levels of uncertainty. For others, the news may come soon after birth with a limited timeframe in which to make a decision. In both cases, parents encounter many uncertainties when faced with making a decision to donate their child’s organs at a time of acute stress, a decision made even more difficult when the healthcare team has little to no familiarity and/or experience with this approach.
Here we aim to provide a resource to highlight clinical barriers that may interfere with neonatal donation, outline the key ethical issues associated with neonatal donation (See Table 1), and propose strategies to overcome these barriers. We argue that neonatal donation ought to be offered to all parents, not only those known in advance to be interested in donation (Table 2). This presentation for donation potential should be similar for infant donations as well. Throughout the paper, we will use the term “consent” because it is common parlance, but acknowledge that in accordance with the AAP Committee on Bioethics 2016 statement [8], we recognize that parents are providing informed permission rather than consent.
Proposals to advance the practice of neonatal donations
The most daunting barrier is the limited nature of the data as pertains to existing practice, evidence, and outcomes reporting on neonatal donations (See Table 1). Although some single-center case studies point to some success, such as Stiers J. et al. who describe cases of successful and unsuccessful donations [9] and Cauley RP et al. who report on a successful multi-visceral transplant from a 2.9 kg donor [10]. A proposed solution entails an effort by participating transplant centers to report their experience and recipient outcomes. We recommend that more research detailing both successful and unsuccessful donations from such a young age group should be highlighted, as well as sharing of best practices among hospitals regarding early donation, in order to analyze feasibility and assess parental or family demand for neonatal donations (Table 2).
Some practical barriers we consider to be relatively non-modifiable. One such barrier is that Organ Procurement Organizations (OPOs) conservatively set a minimum of 6-7 lb.(2.7–3.1Kg.) limit before considering a child as a possible solid organ donor [11], making many lower weight babies ineligible for solid organ donation. This is done collaboratively through guidance provided by transplant centers and surgeons willing to utilize these organs. Of course, the current minimum weight for a neonatal donor- established by the OPO and transplant center - may change in the future with newly accumulated outcome data, similar to how adult donor criteria have been liberalized over the past decades to allow for older individuals to donate. We propose more robust data collection and dissemination of said data by UNOS regarding the practice of neonatal or infant donations before one year of age, to offer guidance to OPOs and institutions considering development of a neonatal donation protocol (Table 2).
Up front, we acknowledge that doubts exist about the successful outcomes of such transplants and about a surgeon’s willingness and expertise in procuring and transplanting such organs. This conservative approach by surgeons is justifiable in light of the regulatory burden that transplant centers face and their accountability to maintain good outcomes post-transplant [12]. Cutoffs for weight and organ size, limited outcomes data, uncertainty about neonatal or infant organs helping other children or adults and even doubts about feasibility of organ use in transplantation all contribute towards murkiness when it comes to presenting neonatal donation as an option to parents or families. Here we recommend that gaining insight from transplant center’s surgical teams regarding institutional feasibility of providing a neonatal donations possibility for parents be evaluated through discussion. The fact that most neonatal donations have been limited due to late or untimely referrals-considered to be so due to lack of awareness regarding appropriate criteria- speaks volumes as described by Stiers et al. [9]. Perhaps this could also be due to lack of skills or lack of concrete knowledge on the subject on the clinical team’s part to present this option to families, which can be modified through broad outcomes data sharing allowing the transplant community to analyze feasibility of the practice and assimilate gains from the practice of neonatal donations.
Ethical considerations associated with neonatal donation
Salient ethical considerations regarding neonatal donations are discussed below.
Preservation of dignity and the ethicality of pre-mortem interventions
Pre-mortem interventions and their ethicality has received much attention and incited continued debate [13 –15]. These are interventions carried out on the patient, before his or her death, to facilitate organ viability in order to optimize organ donation and chances of successful outcomes post-transplant for the recipient. The question then is, can receiving heparin, intubation to ensure viability of organs or trial interruptions of mechanical ventilation be warranted when the fate of the donor remains unaltered or would this be considered in direct violation of the maxim of non-maleficence? Pre-mortem interventions are a particularly sensitive topic [13 –15], even in older pediatric or adult donations. These interventions seem unjustified to some since elective ventilation, for example, is non-beneficial for the donor/patient and therefore violates the maxim of beneficence, although De Lora et al eloquently argue that ventilation is justified from a utilitarian perspective in saving lives of a greater number of patients, while providing dignity to the death of the donors by offering them the chance to donate organs [16]. Here we elaborate to say that pre-mortem interventions would be non-beneficial for the patient per se but may be beneficial for the parent who wants to donate as it makes them more likely to be a successful donor family.
The absence of expressed consent in neonatal donations brings specific attention to the ethical issues associated with pre-mortem interventions. It is recognized that interventions taken to optimize the function of the donor organ(s) may introduce negative consequences for the donor and the donor’s family. While this is the case for donation in the pediatric and adult setting as well, there are specific issues that must be considered in the neonatal setting. For instance, parents of newborns often look to the time right after birth for some comfort or important experiences in their brief moment as a family. It is unclear what benefit or harm this may have for the neonate. Yet, this time may have important implications for the family in terms of how they begin their own grieving and recovery process. This introduces a delay in the initiation of procedures to support the neonate’s organs for donation, contributing towards possible moral distress for all parties even as we recognize that time for the family to grieve is important, a detail specific to neonatal donations.
The authors do not deny the potential for harm that might result after such interventions are undertaken. We do highlight that parental authorization and providing nuanced informed consent can minimize misgivings around neonatal donations and pre-mortem interventions, paving the way for broader acceptance of such donations. Simply put, limiting access to this practice because donors are children means limiting the supply of organs for pediatric, and adult, patients, which is contrary to the aim of the transplant community mission and UNOS, whose charter is dedicated to extending transplantation to as many patients as possible. If the transplant community, and society at large, is dedicated to improving organ supply for recipients in order to save their lives, then similar considerations may be made for neonates who may be candidates for organ donation (Table 2). We acknowledge the need for different consideration for neonatal donors as compared to adult donors yet similar in some senses to infant donations, but in the end also stress that similar steps can be taken to further organ donation [17]. In the adult context in which donors have not expressed a preference towards becoming a donor, authorized surrogates are permitted to make a decision to donate. Similarly, if the parents of the child are motivated and can provide truly informed authorization specific to these interventions, independent of organ donation consent, then these interventions would be justified. In fact curbing their wish to help another dying patient would limit their authority, as echoed by the American Thoracic Society and the International Society for Heart Lung Transplantation in conjunction with the Society Critical Care Medicine [18].
Difficulty in brain death determination in infant and DCDD controversy
It is becoming increasingly recognized that brain death is difficult to ascertain in newborns [19]. The recommendations are for all patients, pediatric and adult, to be evaluated for brain death via 2 exams. For neonates or infants in particular, this is a result of the fact that some brain stem function might persist even after considerable insult, clinical criteria for determining brain death may not be present on admission and could change during treatment due to active therapies, and there may be difficulty in performing testing for brain death after active resuscitation for cardiac arrest. In addition a major consideration is the plasticity of the newborn brain itself leading to more testing need, a longer recommended observation period, and multiple examinations for confirming irreversibility of brain death for neonates. For these reasons, donation after Circulatory Determination of Death (DCDD) is considered a primary mechanism for donation in neonates, a fact that makes the small number of DCDD donation annually surprising for this population (108 infants donated after DND, while 15 donations after DCDD occurredin 2017) [6].
Meanwhile, controversy about DCDD still exists, from professional acceptability among physicians to the uncertainty surrounding wait-time before declaring death after cessation of cardiac pulsation. To say that clinicians are unable to reliably forecast the time taken by neonates from time of extubation to time of death by cardiorespiratory criteria is certainly uncontroversial. This could be a major factor contributing to neonatologists’ or critical care team members’ discomfort in presenting the possibility of neonatal donation as an option to families. In addition, historically there has been robust debate, and at times in the past a partial moratorium on DCDD [20]. Institutional guidelines development to allow due consideration in cases where the family/ parents call for neonatal donation is a pathway that can partially address this issue (See Table 2).
Complimentary to guideline development, another strategy is for transplant centers to meaningfully incorporate discussion about DCDD into their pediatric and obstetric training programs, in order to target such controversial topics using the recommendations by the American Academy of Pediatrics (AAP) [21]. The AAP recommends that DCDD remains an ethical option when practiced under appropriate constraints, providing clinicians with the flexibility to decline to participate in DCDD if they disagree with the ethical underpinnings. This point is reinforced by the recently published Canadian guidelines [22], where they call upon physicians to support institutions to mitigate conflicts of interest inherent in DCDD. Such physician value exploration is crucial to ascertain disciplinary and personal/religious biases among healthcare providers regarding neonatal donation and to explore the factors that might negatively or positively affect those perceptions that influence clinical practice [23]. Such factors could translate to differences in how parents are counseled about their options and draw away from efforts for clear and consistent information to be at the heart of these difficult and often time-sensitive decisions.
Issues in surrogate decision-making for neonates
Paucity of neonates being medically eligible for donation, from weight criteria, organ size, and diagnoses is a fact [11, 24]. Limited published data and outcomes makes the informed consent process more difficult, as previously stated, when the medical community- namely the perinatologist, neonatologist, pediatric ICU team members and obstetricians if the baby is not yet born- themselves are not certain about the chances of successful organ donation and transplant outcomes, perhaps due to lack of education around transplant outcomes in this realm.
We suggest that it is appropriate to discuss with parents that there is some uncertainty about whether organs will be able to be donated. The patient care team may not be aware of parental interest unless they speak with the family when the OPO personnel are also in the room, so some collaboration and coordination between OPO personnel and care teams should be foundational in such circumstances. Another facet of this dilemma is that even in informed assent practices for older pediatric cases for donation, we try to bring together the values and goals of the parents with those of the child - to what extent we know them. A neonate’s or an infant’s values are not yet developed, making this lack of known preferences impossible. This should all factor into the informed consent process, and be made clear for all parents or families to contemplate, understanding that this lack of knowledge about donor values is consistent across older pediatric patients and sometimes pre-teens as well. Provision of truly informed authorization from parents/family for organ donation is our only recourse to mitigate issues related to surrogate decision-making specific to neonatal donations. For example, one issue to explore is the necessary changes to the birth plan or plan for transfer to a facility able to pursue DCDD in order to optimize the chances of donation, especially if the current facility is one where DCDD is not offered. Potential delays or changes in the pathway directly caused by the donation process are therefore necessary, and can be managed through appropriate communication.
Recently published Canadian guidelines single out the case of neonatal donations, recommending that centers which do not have the capability to offer pediatric, or in this case neonatal DCDD, allow for a clear process of transfer to a facility that does offer such services (Statement 49). They go on to state that neonates who cannot donate under a brain death determination should not be precluded for consideration for DCDD (Statement 48)) [22].
Respecting parental wishes and donor interests while balancing the needs for donor organs
Customarily in pediatric situations, clinicians rely on the best interest standard and afford parents the responsibility for authorizing procedures during the child’s life [25], allowing them to decide on the child’s behalf acknowledging the fact that as a family unit their best interests are intertwined and complex. The best interest standard, as applied in pediatrics, seeks to maximize benefits and minimize harms to children. Yet the question in neonatal donations is whether the act of donation would represent the best interest of the donor, when he/she has never had a chance to understand what donation would entail? This query by its very nature questions what the interests are of infants who are nearing certain death and how much the process of organ donation would infringe on those interests. Here we agree with Arthur Caplan when he states that such decisions to donate can only be based upon the sensibilities of parents and the sensibilities and needs of society, keeping in mind what impact public practices can have on social norms surrounding decision-making [23]. Yet an abiding issue is society’s acute need for donated pediatric organs, which directly impacts recipient survival. Neonatal donations, if more widely offered, could help us avoid potential organ wastage, and maximize donations for waitlisted children and adults on the national lists.
Providing meaning to the parents’ loss
Studies show that organ donation may help lend meaning to the parents’ loss and provide comfort while establishing a tangible legacy for their child [26 –28]. Merchant et al find that organ donation can have a beneficial effect on the bereavement process of the family, a finding reflected in fewer reported incidences of depressive symptoms in their study [27]. In the same vein, Corr et al go on to explain that many families come to accept and perhaps revere their identity as a donor family allowing them to feel that some good has come from the donation process [26]. Being informed that their donation was not utilized counts as a secondary loss, leading to another grief response [26]. Organ donation, then, might serve as a powerful mode of meaning-making for parents facing the loss of their child as elaborated by Labrecque et al., who report on indications of families’ interest in neonatal organ donation captured in their medical records review [5]. This is similar to our own center’s experience where parents might actively inquire about the possibility of organ donation, yet another valid argument for providing a mechanism for donation in hospitals, in addition to valuing parental authority.
Given the emotional and psychosocial implications of parents who elect to donate their child’s organs for transplant, it is critical that the needs and values of the parents are adequately addressed -both as a unit facing the loss but also as individuals who may have different emotional responses and needs- throughout the donation process. In some cases, this care may be provided in conjunction with postpartum care for the woman, as her grieving may coincide with the biological and anatomic changes that evolve in the days, weeks, and, in some cases, months after delivery. This is a key place for more collaboration among transplant centers, various specialties and OPOs as well as effectively leveraging existing resources within the hospital such as experienced transplant teams (to assess feasibility of procurement), as well as the local OPOs and pediatric palliative care specialists for perinatologists and neonatologists that are dealing with a prenatal diagnosis regarding a deceased or dying neonate. Not only can this serve to bolster the team but also offer the parents/family a chance to effectively process the loss as well.
Pain amelioration and comfort provision for the child
Currently, all attempts are made to preserve the dignity of the patient, provide comfort until the end of life and to provide the parents with maximal opportunities to spend time with their loved one before and after removal of life-sustaining treatments. Controversy exists, however, in our understanding of how neonates experience pain as we know it [29] and what the self-expression of pain might look like in premature babies versus babies born at term. That is not to say that infants do not experience pain, merely that their discomfort might be different, and so every effort should be made to ameliorate any pain by providing comfort measures such as sedation and analgesia, as for any terminal patient. We believe that it is unethical to merely treat these babies as means to an end but our recommendation is to facilitate donation within the parameters set forth by CMS, the Joint Commission and the American Academy of Pediatrics, helping to balance the needs of the donor against the procedures and necessary interventions that such organ procurement entails by enlisting an inter-disciplinary care approach involving Palliative Medicine [7] (See Table 2).
Resource allocation and transplant ethics considerations
What is the responsibility of the treatment team to a dying pediatric patient, and is it an ethical conflict of interest to ask physicians and team members to broach the subject of donation with their patient families? Or is it that they are uniquely situated to adjudicate this potential conflict of interest if dealt with transparently and with full disclosure? This also calls into question what physicians’ obligations and duties are to their patients whose condition is terminal, balanced against their care of other similarly situated patients who could benefit from organ donation. This dilemma is imposed on the medical community due to the ever-lengthening gap between organ supply and demand, a fact that warrants more widespread education for physicians from both neonatal and pediatric specialties as well as all other healthcare teams not directly related to transplantation. The authors think that it is reasonable to say that we need to consider discussions about peri-viable delivery where there is debate about how to weigh the risks and benefits of an obstetric plan (C-section vs vaginal delivery) against the possible expected benefits for the neonate. We have a unique perspective in recognizing that neonatal donation is an important disciplinary intersection of donation, pediatric, and obstetric ethical discourses.
Currently, CMS mandates that hospitals refer all appropriate patients to Organ Procurement Organizations (OPOs) for further assessment and workup for donation (See Table 2). This de-couples the process from all interests regarding patient critical care, mitigating public objections about physician conflicts of interest. We support the current standard that after a decision has been by parents to pursue end of life care, consent for DCDD should be obtained by OPO personnel, but propose that consent for pre-mortem interventions to support donation should be undertaken by OPOs in conjunction with the critical care team, with continued attention to eliminating the conflict of interest created by physicians providing end-of-life care and optimizing donor organs concurrently. We stress that both the critical care teams and the parents must understand that the OPO personnel have no role in the decision to withdraw life-sustaining therapy, and are present merely to signal continuity of potential to donate for the patient in question.
Dilemmas of intrapartum care for mothers in cases of terminal diagnosis for the fetus
This is the case for all healthcare providers but may present specific challenges in the neonatal context, particularly when there is a high likelihood of a neonatal death shortly after delivery. These cases raise important questions about what members of the healthcare team should initiate or be part of such discussions. Most typically, complex obstetric patients are cared for by a multidisciplinary team of experts, including a maternal-fetal medicine specialist and a neonatal specialist. Both of these experts may have specific expertise in patient and family discussions when there is a serious medical concern for the neonate. The healthcare team may also include the primary obstetric provider, as this may be the individual with whom a pregnant patient and partner may have an enduring as well as trusting relationship over the course of the current or prior pregnancies, and may also include a fetal care plan team that includes a palliative care specialist. As part of a multidisciplinary approach inherent in these kinds of discussions, all members of the team can work together to facilitate evidence-based and sensitive discussions regarding the expected outcome of the neonate. Because of the nature of their specialty, neonatologists will most likely have greater experience with outcomes in the neonatal period and may be better positioned to discuss aspects of donation after birth, helping to form a cohesive synergy between obstetricians and neonatologists which can act to enhance the parent’s confidence in their care team (Table 2). This is specific when it comes to discussing or planning neonatal donations because there is arguably synergy within these two groups of providers more broadly in other contexts as well.
The possibility of neonatal organ donation shortly after birth will most likely lead to discussions regarding intrapartum management. The primary thrust of any such discussions should focus on the health and wellbeing of the pregnant women, including decisions that may affect her current health and future reproductive decision-making. Yet, discussions about neonatal donation may lead to subtle or more obvious messages for the pregnant women to undergo interventions during pregnancy and labor tooptimize outcome for the neonate whose organs will be donated. This may include emergent cesarean section if fetal heart tones demonstrate departure from expected patterns, or scheduled surgery in women who have had a prior cesarean section in place of a trial of labor for a vaginal delivery, each with implications for her health, both short- and long-term. Thus, the obstetric members of the team can help ground counseling about donation in a way that helps patients and their families balance their goals of neonatal donation with their values and needs in the years to follow.
Conclusions
More neonatal donations could attenuate the organ gap that transplant medicine faces today especially in the realm of pediatric organ shortages. Further consensus regarding DCDD within the medical community must be reached for neonatal donations to increase nationwide, a process that would benefit from further process clarification, research and broad policy attention in the shape of national guidelines addressing the issue so that hospitals can begin to have a policy and protocol development for all parents and families to consider.
Disclosure statements
The authors have no financial relationships relevant to this article to disclose.
Footnotes
Acknowledgments
We would like to acknowledge Martin L. Smith, Christine Chambers, Dr. Samir Latifi, Dr. Natalie Yeaney, and Dr. Sabine Iben for their thoughtful comments and insights on this article.