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Organ transplantation provides life-saving treatment for children with severe end-organ failure, using organs usually sourced from live-related or cadaveric donors.
Infants under 2 months in the UK do not donate organs, whereas in other, similarly developed, healthcare systems, such donation and transplantation are routine. Indeed, infant hearts donated in Europe are retrieved and transplanted in the UK. Furthermore, other organs may soon be realistically transplantable in the first months of life.
In 1988, the Conference of Medical Royal Colleges produced a report on neonatal organ transplantation long before this was feasible.1 Now the technical capabilities have arrived, it is surely time to reconsider this area.
This paper considers the practical, ethical and legal issues surrounding organ donation from UK neonatal units.
While philosophers debate definitions and criteria for death, for clinicians the practical tests used to certify death remain paramount.2 The Academy of Medical Royal Colleges (AoMRC) ‘Code of Practice for the Diagnosis and Confirmation of Death’3 offers authoritative guidance, maintaining the 1991 British Paediatric Association (BPA) standards4 for diagnosing death in children using either cardiorespiratory or neurological criteria. While prima facie acceptable, the devil for paediatricians is in the detail, and the relevance of the document to infant organ transplantation will be explored.
In UK neonatal practice, death is certified using cardiorespiratory criteria, the examination performed to certify death for anyone dying outside intensive care. No breath sounds, no heart sounds, pupils fixed and dilated is a frequent final entry in medical notes.
Clinicians in adult and paediatric intensive care units (PICU) are also familiar with the concept of neurological death, which in the UK is brainstem death (BSD) certifiable by bedside brainstem tests.3 BSD is usually a result of traumatic or hypoxic brain injury, causing sustained raised intracranial pressure, leading to cerebellar tonsil herniation through the foramen magnum, thereby irreversibly compressing the medulla—a process referred to as coning.
BSD actually developed to predict somatic death, with no connection to transplantation.5 However, it has become clear that clinicians and the public accept neurological death as true death, and today few within medicine or society debate its validity, which is recognised under common law.6
Cadaveric organ donation after BSD, or donation after brain death (DBD), is currently the only source of hearts for transplantation and provides other organs optimally, due to a persistent endogenous circulation up to harvest. After BSD certification, a child's body remains on PICU for stabilisation through the BSD-associated sympathetic storm, which improves both the quality and quantity of organs donated.7 After retrieval in theatre, the body usually returns to PICU for end-of-life care.
The other mode of organ provision after death, donation after circulatory death (DCD), follows certification using cardiorespiratory criteria and is actually increasing, whereas DBD rates are decreasing.8 The organ yield from DCD is lower, and retrieval must occur within a relatively short period following cardiorespiratory arrest due to warm ischaemic damage. DCD can be planned after a decision is made to withdraw invasive organ support in a suitable child's best interests.
Persuasive arguments suggest absent heart sounds, pulse and blood pressure are the key factors in declaring death by cardiorespiratory criteria9 with DCD programmes using either a 10 min Maastricht Workshop time10 or the US Institute of Medicine proposed 5 min in this context,11 although some specify asystole.
Organ donation does not occur in UK neonatal intensive care unit (NICU), with national guidance suggesting that under 2 months of age, neurological death cannot be reliably determined,3 4 essentially proscribing neonatal DBD. An uncomfortable corollary is that US, Canadian, Australian and other European neonatologists certifying neurological death permit retrieval from infants not dead by UK standards. Furthermore, transplant teams use such hearts imported from Europe for British infants.12 While such transplants are rare, several UK infants die of myocarditis annually, and standard treatments for US infants with hypoplastic left heart syndrome include primary transplantation, an option not offered to here due to organ availability. This cannot withstand reasoned argument, and will surely form a debating point for the Organ Donation Ethics Group, recently convened following the Organ Donor Task Force report,13 which aims to address poor UK donation rates.
Possible organ donation from NICU
The following section will explore donation from NICU, initially by considering babies who die and who could technically donate organs, then reviewing the relevant ethical issues.
Most units have occasional babies with severe birth asphyxia who, despite transfer and cooling,14 have profound neurological impairment. In the most severe cases, invasive support is withdrawn on the grounds of ‘no purpose’ in line with Royal College of Paediatrics and Child Health (RCPCH) withholding and withdrawal guidelines.15 It is scientifically possible to transplant organs from infants certified by cardiorespiratory criteria into others dying from organ failure,16 and the range of organs is likely to increase.17
While there is a paucity of literature regarding neonatal DCD, the critical technical aspect remains minimisation of warm ischaemia to organs after circulatory arrest, and research is needed into the organ-specific times tolerable to permit viable transplantation.
As most NICUs are remote from transplant centres, two DCD models are logical. First, as in paediatric DCD, donor transplant coordinators could attend the NICU in which an elective withdrawal was planned, and if consent was forthcoming, a transplant team assemble in that hospital's theatre, and after withdrawal and certification, the body be moved to theatre for retrieval.
The second possibility is transfer of infants, with parental consent, to transplant centres before withdrawal. Although feasible, for many this would fall outside even extended concepts of best interests, which will be discussed in regards to ethical issues.
Regarding tissue donation, retrieval of neonatal heart valves occurs, although most infant valve replacements use anatomically larger valves to avoid early re-replacement. The process of such donation needs further consideration.
In the UK and commonwealth countries, neurological death is BSD, which is confirmed by bedside testing,3 whereas in the USA whole-brain death is the standard which requires some form of investigational testing demonstrating complete loss of higher brain functions in addition to BSD,18 although significant variations in practice exist.19
While rare, some term babies do suffer catastrophic cerebral events, for example, bilateral cerebral infarcts due to a vein of Galen anomaly, and can fulfil standard BSD criteria. UK guidance,3 however, suggests such a diagnosis to be unwise, precluding neonatal DBD irrespective of parental views.
Lack of development of brain stem responses in premature infants means standard BSD is inappropriate, and in other countries infant neurological death protocols also have investigational testing as above, together with a more prolonged period between clinical assessments of neurological function than here. Surely, given the approach taken by other commonwealth countries, the 1991 BPA position should undergo rigorous ethical discussion. If such debate favoured the logical choice of neurological death in neonates using confirmatory tests, such as electrophysiology or radio-nucleotide imaging, then adoption of the Canadian standards on neonatal neurological determination of death (figure 1) could be considered, though of course the corollary would be a different neurological death standard in the UK for infants.
Overall, the discrepancy between UK and non-UK practice seems logically unsustainable.
Practically, many potential babies with neurological death will be in neurosurgical centres, with intracranial vascular anomalies or traumatic—often inflicted—brain injury. Such units have clinical expertise, albeit in different populations, in neurological death.
Others might have been transferred to tertiary NICUs for cooling following severe birth asphyxia. This would be infrequent for any individual unit, so excellent guidelines and governance processes would be required. Neonatal networks offer a structure for donation in this context, with potentially one dedicated network clinician tasked to work with the senior nurse in organ donation, clinical lead for organ donation and donation committees of each NHS Trust in that network.
Currently, cardiac donation in this context offers an opportunity to save the lives of infants with myocarditis,20 and would be an attractive option for the many others facing multiple palliative operations.21 It is likely that other organs, such as small bowel, from this source could soon be used for infants with severe chronic organ failure.22
Sporadic organ donation from anencephalic infants has occurred in the UK, though not for decades. More formal US programmes recently ceased following ethical debate, and currently no country seems to transplant such organs. Surprisingly, the most recent UK guidelines, unchanged hence de facto endorsed by both the BPA and AoMRC documents,1 permit such donation suggesting: ‘….that the absence of the forebrain in anencephalic infants together with apnoea shall be recognized as death.’1
The document also states that: ‘…organs for transplantation may be removed from anencephalic infants when two doctors who are not members of a transplant team agree that spontaneous respiration has ceased.’1
Furthermore, such donation is apparently lawful, with parental consent, and causes no concerns for Coroners or the Human Tissue Authority (personal communication from Great Ormond Street Hospital Solicitor after discussions with senior legal counsel, HM Coroner and the Human Tissue Authority). There are, however, practical difficulties with using rather historical guidelines given the interim changes in neonatal practice. One particular challenge is the diagnosis of terminal apnoea, which was not defined by the working party. Contemporary guidance should be ascertained by establishing a cross-disciplinary working group to consider the ethical issues and to make an overall determination of the neurological status of such infants, the practical medical interventions permitted and whether death certification and transplantation are ethically robust.
Ethical aspects to neonatal organ donation
Most of the ethical issues are not unique, death being a pervasive concept. However, despite an extensive philosophical literature, few of the major issues are resolved: is death an event or a process?23 How soon can death be confirmed following cessation of cardiorespiratory function, and are electrical or clinical means optimal? What is it permissible to undertake with a dying person to facilitate organ donation, if they or their family have expressed this preference?24 Recent UK legal guidance is most welcome.25
The complete dependence of a human being, incapable of contributing to decision-making, yet ordinarily expected to develop into a fully competent individual, is a challenge familiar to neonatologists. The ethical and legal standard is that parents, or those with parental responsibility, are afforded the responsibility—no other term suffices—to consent for their child under the understanding that they make a decision in that child's best interests. While best interests are not well defined, the Court of Appeal has clarified the legal evolution away from limited medical best interests to include medical, emotional and other interests.26
Could it be in a dying baby's best interests to donate organs so others might survive? When should parental autonomy be trumped by medical autonomy in preventing donation, and which interventions so compromise a dying child that such intervention is warranted? There seem some obvious answers: surely society will continue to limit donation to those certified as dead—irrespective of parental views. This ‘dead donor rule,’ recently challenged by Truog and Miller,27 who argued against neurological death per se, advocating donation from the dying, seems inviolable. Invasive ante mortem interventions, such as femoral cannulation for cold perfusate and therapeutic anti-coagulation to preserve organ function, seem similarly ethically proscribed.
For NICUs that ultimately facilitate DCD, withdrawal and certification on the unit before rapid transfer to theatre for harvest seem likely, however, transfer to theatre for withdrawal is increasingly accepted,28 and some units might consider this, depending on hospital geography.
After the Alder Hey controversy parents of children who die have unprecedented control over their child's body, including decision-making over the disposal of, not just tissue, but histological slides.29 It seems that parental autonomy in this regard is accepted, outside coronial jurisdiction. Surely, once a baby is dead, fully informed parental wishes for organ donation, or indeed related research, should be honoured where possible.
We are left, therefore, with the remaining major ethical deliberation in neonatal organ donation being the certification of death.
Certification of death
It is surely illogical to sustain objections to neurological death in infants under 2 months, given standard international practice, and the implications of ongoing deaths of other infants. Clinicians happy to certify neonatal BSD should be permitted to do so, with liaison and training with local neurosurgical centres. The issue of accessory testing and the BPA document should be urgently revisited.
Certification of death in anencephalic infants, whose parents wish to donate organs, is a significant challenge. The previous guidance1 is medically antiquated, and should be reviewed by an appropriate group, including the RCPCH ethics committee. A possible change—arguably compatible with current ethical mores—is to permit intubation of such infants to ascertain neurological status in life, and then consider certification of a type of neurological death if appropriate, thereby enabling organ donation. Could this be considered in an anencephalic infant's best interests, if this is the parents' wish? Might respect for parental decisions in the UK mean such wishes be honoured more than elsewhere, outwith extraneous religious and societal viewpoints?
The time when death was certified after circulatory cessation was controversially reduced to 70 s in a US DCD infant cardiac transplant series.16 Of course, interventional resuscitation is possible after this time, which was based upon ‘auto-resuscitation’ extremes from the literature. In reality, any UK infant DCD would use similar protocols to paediatric DCD, with a 5 min interval after cardiorespiratory arrest.
For those of a utilitarian perspective, the US series lead to three live infants and three dead donors, rather than six dead infants. What aspect of a Kantian or other ethical viewpoint is breached in such donation? The standard objection encountered is that dying patients should not merely be treated as a potential source of organs, but as a human being. Should withdrawal be deferred until retrieval teams attend? Why should children and babies die in theatres, rather than on the NICU—or even at home? Surely a physician's duty is to the child they are caring for, rather than some remote child they will never meet?
It is not clear which of the above manoeuvres treats a person as only a source of organs, rather than a human being, and on what basis the claim is made. While these complex issues might conceivably be resolved in considering some extended duty of care to remote dying children, in reality a satisfactorily resolution is found in broader best interests, such as a child's wish to help others, as expressed by parental informed consent. Harris and Holm delineate this concept well in considering small children in medical research.30 They suggest we should not presume moral turpitude in children, but rather presume them to be altruistic communitarian social beings, who would wish others well.
What is already known on this topic
▶ In many other countries, term babies with catastrophic brain injury can, in the same way as children and adults, be certified as having died using neurological criteria.
▶ Organ donation and transplantation in the neonatal and early infancy period are technically possible and occur in other countries, but not in the UK, as current clinical guidelines do not support his.
What this study adds
▶ Parents of dead babies have unprecedented decision-making over disposal of their child's body, apart from in donating organs to others.
▶ Ethical and legal standards arguably support neonatal organ donation, and incompatible guidelines should be urgently addressed by a new working party.
▶ Anencephalic donation, although legal, should be ethically reviewed by a crossparty group and consensus established.
Though neonatal organ donation is technically feasible, and occurs in other countries, UK parents are not allowed to donate their dead baby's organs.
If the wish of a dying baby can be presumed to be altruistic, and represented best by its parents, then what objections to neonatal organ donation are sustainable?
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.
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