Successful implementation of pcDCDD programs requires multiple foundational elements. Key components include, but are not limited to, an enabling legal withdrawal of life sustaining measures (WLSM) framework, structured clinical education, accountable referral and coordination processes, and sustained governance and funding mechanisms.

It is critical to have a legal framework that allows for the WLSM, and the determination of death based on circulatory criteria in children (see Table 2). Without such legal clarity, no pcDCDD program or policy and procedure can safely develop or be sustained, as healthcare professionals require a legal mandate to perform pcDCDD. A legal framework is also essential for public trust in end-of-life care and donation activities.

A legal mandate is necessary for policy and procedure but is not sufficient for successful pcDCDD programs. While we do not have detailed international pediatric donor audit information to truly evaluate referral and consent performance, low rates in many countries with pcDCDD programs suggest that implementation of pDCDD remains a challenge (Figure 1). Development of programs requires ongoing education of healthcare professionals caring for paediatric patients (physicians, nursing, respiratory therapy, pharmacists, child life specialist, spiritual support, social workers and other members of the multidisciplinary team) to ensure that donation opportunities are offered to families in a timely and sensitive way. All healthcare professionals need regular reminders about the importance of identification and referral, especially because donation opportunities are infrequent and the potential benefits for donor families are impossible without referral [1, 12]. Ongoing communication between donor coordinators (DCs) or the staff of organ procurement organizations (OPO), intensive care teams and transplant programs should be established to ensure that referral criteria are consistent with surgical capacity and expertise. These logistic and implementation challenges require consistent funding and clear governance models.

The importance of designing clinical protocols to avoid missed opportunities for pcDCDD was evident in strong consensus favouring the establishment of clinical triggers for identification and referral of all potential pcDCDD donors (Table 3). Universal identification and referral of patients who are potential deceased organ donors is well documented as a key aspect of a successful system [23, 24]. This is particularly relevant in paediatrics, where potential donors are less frequent and therefore missed opportunities more critical [12, 18]. The precise clinical triggers for referral can vary slightly by jurisdiction but generally apply to any child for whom withdrawal of mechanical ventilatory or circulatory support is anticipated. All healthcare professionals who care for such children should be educated about the specifics of those triggers and empowered to refer when appropriate.

Surveys of intensive care adult and paediatric intensive care physicians suggest that they sometimes choose not to offer donation based on misconceptions around donor eligibility or assumptions regarding the family’s likelihood of consent/authorization [10, 25, 26]. Related surveys also showed that many healthcare professionals are not aware of legal requirements requiring referral, emphasizing the need for education around the implications of clinical triggers [10, 27]. Making referral a routine consideration for healthcare professionals during WLSM planning allows for normalization of donation as part of end-of-life care, which in turn ensures that no family who may have wished to pursue donation is denied that opportunity. Involvement of palliative care specialists can be beneficial when planning WLSM. Local protocols should be established regarding who contacts the family regarding donation and at what stage of the process that respects local resources and legal framework.

There is wide variability in the utilization of organs obtained via pcDCDD [5, 28]. This is in part due to substantive variation in the eligibility criteria and the diverse age range for paediatric donors, which in turn are likely influenced by local resources and capacity to transplant organs from paediatric donors with particular characteristics (see Box 1). Some programs transplant kidneys from pcDCDD donor infants as small as 1.9 kg [29] whereas others will only consider children over 5–10 kg [30]. While most common in the neonatal population, lower rates of pcDCDD organ utilisation have been reported in all age groups [13, 31]. This can lead to frustrating situations when families agree to donation, but perceived technical difficulties and surgical expertise regarding donor size or a lack of compatible recipients preclude donation. It is therefore important to have clear criteria that define medical suitability and priorities for pcDCDD that are implemented by local resources with available medical and surgical expertise. For example, capacity for donation of paediatric hearts following pcDCDD should be developed, due to the severity of unmet needs for heart transplantation in the paediatric population and the difficulties of size matching [32, 33]. Evaluations of donor potential and medical suitability in individual cases should strive to identify modifiable factors that may be limiting opportunities for pcDCDD. Medical suitability decisions about patients who may be considered “borderline” – for example, just above or below weight limit thresholds–are complex and will likely vary based on expertise of the medical and surgical transplant team [30].

Similarly, predictions around time to death are imprecise in patients undergoing planned WLSM [34], and very little data are available regarding such prognostication in paediatric patients [34–36]. Physician assessment or use of clinical tools based on patient factors are informative, but even in adults negative and positive predictive values remain around 80%–85% even with the best current models [34]. Thus it is often difficult to predict which children are likely to die following WLSM in a time frame that will enable successful recovery of organs for transplantation via the pcDCDD pathway [37]. The combined uncertainty around time to death and organ utilization can make transplanters and donation system administrators reluctant to invest the substantial resources required to pursue potential pcDCDD cases when the process might not end in successful transplantation. Despite fewer pcDCDD cases, this should not be a deterrent as similar concerns exist for DCDD in adults. Research is underway to improve prediction of death tools [38] in adults and eventually paediatric patients and international transplant outcome reporting should be encouraged to better define characteristics associated with favourable graft and patient outcomes from the pcDCDD pathway.

Several consensus recommendations focus on the adequate timing and approaches to informing patients, where appropriate and possible, their parents or other substitute decision-makers, about opportunities for pcDCDD (see Table 5). Organ donation is rare in children and many paediatric healthcare professionals lack confidence or expertise in donation. Organ donation discussions require trained donation personnel to assist with the donation process though the timely availability of that personnel may be limited due to resource constraints.

Evidence suggests that involving donation professionals increases consent/authorization rates for paediatric deceased donation [14, 26]. Potential conflict of interest about WLSM and donation issues has raised concerns that decisions may be influenced by donation professionals [39]. While there was strong consensus that decisions about donation should be separate from conversations and decisions about WLSM, countries may have different protocols for decision-making, diversity in laws governing donation, health system resources, and the responsibilities of donation personnel in these situations. Complete decoupling of end-of-life and donation decisions is not always possible. For example, families may mention the possibility of donation before final decisions about WLSM have been made. The recommendations are consistent with existing guidance that emphasises clear communication with families that focuses on the ongoing goals of treatment while discussing donation when it becomes a possibility or is raised by the family [17].

How to incorporate a child’s previously expressed intentions or preferences in making formal decisions about donation opportunities has been a focus of considerable legal and ethical analysis [17, 40, 41]. The legal age of consent/authorization for medical treatment decision-making varies between jurisdictions and may differ from the age of consent/authorization for donation decisions. Some countries include the concept of “emancipated” or “mature” minors who may in specific circumstances be permitted to consent to medical procedures or to refuse life sustaining interventions if they are deemed to have the mental capacity and maturity to make such decisions [40–42]. When supporting decision-making about pcDCDD, healthcare professionals should be aware of relevant legal considerations in their jurisdiction, and ensure that a child’s legal rights are respected. This may entail respecting a child’s decision about WLSM and/or donation; more commonly it may require giving careful consideration to a child’s known or presumed values and preferences with regards to end-of-life care and donation.

There was consensus (see Table 6) that, when it is lawful to do so, a competent child’s expressed values and preferences should be respected where possible in decision-making about end-of-life care and donation. However, there was also consensus that a child’s parents or substitute decision maker (SDM) should make decisions about end-of-life care based on what they believe would be best for the child, all things considered. This raises the possibility of conflicts if a child’s known wishes are judged to be inconsistent with what lawful decision-makers believe would be best for the child. It is possible but unclear if panellists associated the latter recommendation with decision-making for children who had not expressed or were not competent to have made informed wishes regarding end-of-life care. Any potential contradiction and confusion is nevertheless resolved by the recommendation that a competent child’s known or presumed decision should be respected even if this conflicts with what SDMs believe is best for the child, provided such an approach is lawful.

Where the law does not mandate consideration of a child’s views, parents or SDM should nevertheless be encouraged to consider any known or estimated wishes regarding donation into account [17, 26, 43, 44]. The weight given to any expressed preference or the values of a minor child will depend on several factors, including the maturity of the child, the child’s intellectual capacity, and the clarity of the expressed intention [45]. Most children, even adolescents who may have legal capacity to consent to medical decisions, will likely never have expressed an intent regarding deceased organ donation, and estimation of their preferences may not always be possible especially in the case of younger children.

Similar to adult DCDD processes, some ante mortem interventions will be required for completion of any pcDCDD process. The broader consensus project defined such interventions as “Any clinical procedure or test that is performed before death for the purpose of organ or tissue donation and transplantation, which would not occur in the absence of consideration of donation.” [19] Blood draws and radiologic examinations are necessary to determine donor and organ eligibility and recipient compatibility, and the timing and location of WLSM will change to accommodate pcDCDD logistics [18]; heparin administration during WLSM, more invasive investigations may also be requested by transplant teams, such as biopsies or bronchoscopy. These interventions have often been implemented based on an inferences from physiologic principles, though few have been rigorously evaluated in high quality studies and even fewer in paediatric patients [39, 52, 53]. There was consensus regarding the need for research to provide evidence regarding the potential benefits and harms of ante mortem interventions in pcDCDD (see Table 7), and a recommendation that interventions should only be considered where there is a clear clinical justification for their potential to optimise donation and transplantation. Research will inform the broader questions of which investigations or interventions should be routinely recommended and help to support decision-making about their use.

Consensus was not sought on a defined set of ethically acceptable interventions for use in pcDCDD, nor did we seek to specify interventions for which consent may or may be presumed, as the risks and potential benefits of particular interventions may change over time and legal definitions of ante mortem interventions or consent requirements vary between jurisdictions [54]. Instead, consensus was pursued on the principles that should guide the approach to evaluation of and decision-making about use of ante mortem interventions for pcDCDD in any jurisdiction.

The importance of informed decision-making about use of ante mortem interventions in pcDCDD is evident in the recommendations outlined in Table 7. The limitations of the available evidence regarding interventions for pcDCDD were also recognized in the recommendation for research. While there was agreement that consent for interventions may sometimes be reasonably and lawfully presumed, it was recommended that even if specific consent is not required, best practice involves keeping families informed about all aspects of donation processes. This approach is also consistent with routine end-of-life care, where patients and/or their families are regularly updated on what is happening and why, even when explicit consent is not sought for interventions such as repeated blood tests or administration of medications. The recommendations are aligned with previous work that emphasises the importance of tailoring information to the preferences of parents or SDM, while respecting legal requirements [43, 55, 56].

Several considerations were identified as relevant for informed decision-making about use of ante mortem interventions in pcDCDD (see Table 7). Information about the child’s known or estimated preferences and goals with regards to end-of-life care and donation was considered important in guiding decision-making where possible, consistent with the aforementioned recommendations regarding end-of-life care and donation decision-making in the context of pcDCDD (see Table 6). The possibility of achieving a child’s known or estimated donation goals or those of their family is evidently a key potential benefit of using ante mortem interventions that may balance concerns about the potential burdens of some interventions [43].

While the recommendations in this paper are largely consistent with those reported in the context of the adult cDCDD pathway [57], some ethical considerations may be more complex in the paediatric setting. When compared to adults, children’s goals or preferences with regards to donation or end-of-life care, let alone ante mortem interventions, are far less likely to be known or able to be inferred depending on the age of the child. Reliance on a ‘best interests’ approach to decision-making rather than making decisions based on the potential donor’s known or inferred preferences is not unique to cDCDD in the paediatric setting, however, parental beliefs, familial interests, and decisions and interest of the child can create challenges and complicate decisions. For example, some authors have cautioned against the possibility that grieving parents may consent to ante mortem interventions that are unduly burdensome for the child in order to improve the possibility of donation [58]. Conversely, some parents might be unwilling to agree to interventions of negligible burden or risk, or pcDCDD more generally, if they believe the impact of the donation process may be burdensome [43]. Clear guidance for parents and SDM is required as they remain responsible and must agree to decisions regarding end-of-life care and organ donation.

While robust, the methodology of this Consensus Project has several limitations, as outlined elsewhere [19]. Although the consensus achieved by this diverse panel of experts suggests a reassuring level of agreement at the principled level internationally, a degree of bias is inevitable. Paediatric deceased donation, and pcDCDD in particular, is a relatively small field of activity with limited available evidence to support best practices or to inform the estimation of values and preferences of various stakeholders. Consequently, some of the recommendations outlined herein may be difficult to translate into policy and practice in some contexts or may lack the specificity to provide substantive guidance where some changes are needed. Resource limitation and cultural considerations can clearly impact individual jurisdictions for pcDCDD and must be considered.