Spain is an international leader in organ donation and transplantation. In 2019 the organ donation rate was 49 per million inhabitants, with performance of 5449 solid organ transplants, the result of a management system structured to systematically identify potential donors and ensure effective donation.1 There were 163 solid organ transplants from donors under 16 years of age. In the paediatric population, there are several complications at both the donation and the transplantation levels that result in a decreased probability of transplantation in children compared to adults.1

There are many reasons for the lower rate of donation in the paediatric population. Fortunately, child mortality is low, overall (ranging from 2.68 per 1000 inhabitants in infants aged less than 1 year to 0.07 per 1000 inhabitants in children aged 10–14 years) and in the paediatric intensive care unit (PICU) setting (approximately 2% of admissions to PICU).2 Infants and children considered potential donors require a complex and specific evaluation of each organ in addition to the evaluation involved in donor-recipient matching. In addition, controlled paediatric donation after circulatory death (pDCD) is still exceptional.3

Thus, additional efforts and strategies are needed to maximise the availability and benefit of transplantation for children and to ensure that the option of donation is offered to children and families as part of end-of-life care. Along these lines, the 2018–2022 strategic plan of the Organización Nacional de Trasplantes (National Transplant Organization, ONT) includes the objective of optimising paediatric donation and transplantation, for which a specific working group has been created through the collaboration of the Asociación Española de Pediatría (Spanish Association of Pediatrics, AEP) and the ONT (Appendix A). This group has developed a consensus document to facilitate the process of donation in children and infants and analysing the associated ethical dilemmas. The document specifically elaborates on the process of pDCD, including pDCD in special situations (severe central nervous system anomalies incompatible with life and children in palliative care). This article is a summary of the full document, which is available through the ONT and the AEP.4

We formed a group of experts selected by the ONT and the AEP. The project did not receive any external funding and participants reported having no conflicts of interest. The ONT coordinated the working group, held in-person meetings in its headquarters and facilitated a shared working platform.

The recommendations are based on current scientific evidence, documents published by international organizations and expert consensus taking into account the social reality and current law in Spain. Ethical and legal aspects were reviewed and discussed in depth with the collaboration of experts in bioethics of the ONT. Before the document was approved, it was subject to a public consultation process involving professionals affiliated to numerous scientific societies. The final version of this document has been endorsed and adopted by the Transplantation Commission of the Interterritorial Council of the National Health System and the executive board of the AEP.

Paediatric donation is encompassed in end-of-life care and therefore recommendations have been issued to consider it both in case of brain death (BD) and after the decision for withdrawal/withholding life-sustaining treatment (WLST), when the possibility of donation following determination of death based on circulatory and respiratory parameters can be brought up, as established by Royal Decree 1723/2012.5,6

Paediatric donation involves shared decision-making with the family (family-centred care), and it is the parents that, based on the information received and their own values and beliefs, may consent to their child becoming a donor if they perceive it as something positive for the child and for themselves.

In Spain, parents and legal guardians are the sole parties authorised to decide whether a minor aged less than 18 years can become a donor, although 3 ethical principles must be applied: a) “do no harm” to the child; b) “substituted judgment”, by which the proxy decision-maker needs to answer the question “if the child was sufficiently mature, what would he or she elect?”, and c) the “best interests” of the child, which involve answering the question “do we want what would be best for our child?”.

Donation may be beneficial to the family by offering an option that could give some meaning to the loss of the child, who would leave a legacy of life for other people and that, in being an altruistic act, could counteract the tragedy of the premature death of a child.

If parents consider organ or tissue donation to fit their values and express it to be so, the care team and the transplant coordinator (TC) must integrate this decision in the care plan, providing a simple, clear and compassionate explanation of the details of the process.

From an ethical standpoint, the transition from WLST to obtaining consent for donation may appear complex and conflict-ridden, as care at the end of life may need to be prolonged to make donation possible. The care team will contact the TC early on and clearly explain to the family that the processes of WLST and of donation are independent and that end-of-life care will be provided in any case, even if donation is refused.

It entails a comprehensive evaluation to, on one hand, rule out the presence of diseases that could be potentially transmitted from donor to recipient (especially in potential donors with cancer or infectious disease) and, on the other, will assess the structure and function of organs that could be transplanted, always taking into account that one not being suitable does not mean that others could not be viable.

The details of this evaluation (comprehensive history taking, thorough physical examination and diagnostic tests), including an addendum on the subject of infection by coronavirus, are given in the full document of the working group4 and summarised in Table 1.

Once the necessary information is collected, the paediatrician in charge will contact the TC, who will in turn decide which organs and tissues are suitable for transplantation.

The diagnosis of BD is an absolute requisite for paediatric donation, one that is therefore specifically expressed in a Royal Decree in Spain (1723/2012).6 Spain and other countries have developed various guidelines on the subject.7 The document of the ONT-AEP provides a detailed explanation of the process for determining BD in children,4 of which we provide the key points:

• a)

  Factors supporting diagnosis. Irreversible coma of unknown aetiology with clinical features or imaging findings consistent with devastating brain injury. Reversible causes of coma and apnoea must be ruled out, especially drugs known to depress the CNS.

• b)

  Neurologic examination. It must be systematic and thorough, ensuring that the prerequisites detailed in Table 2 are met. Key findings include irreversible coma, absence of brainstem reflexes, lack of response to atropine administration and apnoea.

  Table 2.

  Prerequisites for neurologic evaluation of children with suspected brain death.

  Haemodynamic and metabolic stability

  Adequate oxygenation and ventilation

  Body temperature: > 35 °C in children < 2 years and > 32 °C in older children

  More than 24 h elapsed from the time of brain damage

  Absence of neuromuscular blockers

  Sufficient time elapsed for elimination of CNS depressant drugs

  Evidence of a cause of death
• c)

  Observation period. The length must be determined based on the type and severity of the damage and the tests performed (Table 3).

  Table 3.

  Observation periods required for diagnosis of brain death in children per Royal Decree 1723/2012.

  	Exclusively clinical diagnosis	Clinical diagnosis and one instrumental testa
  Preterm newborn (< 37 weeks)	48 h	The observation period may be shortened as deemed appropriate by the clinician based on the findings of performed instrumental tests and may be omitted if a diagnostic test unequivocally proves absence of cerebral blood flow
  Newborn (37 weeks’ gestation to 20 days post birth)	24 h
  CHILD (age 30 days-24 months)	12 h
  CHILD aged more than 2 years with devastating brain injury	6 h	The established observation periods may be shortened or even omitted as deemed appropriate by the clinician based on instrumental diagnostic tests performed in accordance to the protocols established for adults
  CHILD aged more than 2 years with anoxic brain injury	24 h

  In case of suspected or known exposure to drugs known to have a depressant effect, the observation period should be prolonged as deemed appropriate by the clinician.

  a

  In children aged less than 2 years, the instrumental test must provide unequivocal evidence of the absence of cerebral blood flow.
• d)

  Confirmatory instrumental tests of brain death. They include tests that assess neuronal function (electroencephalogram and evoked potentials) and cerebral blood flow (arteriography, digital subtraction angiography, cerebral scintigraphy, transcranial Doppler ultrasound, multidetector computed tomography [CT] angiography of the head and magnetic resonance angiography). One or several of these tests must be performed when the neurologic evaluation is inconclusive or for the purpose of shortening the observation period. Each of these techniques has limitations when it comes to children, so individualised selection of imaging tests is recommended, in addition to, if possible, the combination of 2 or more of these tests.

The management of paediatric organ or tissue donors include interventions aimed at maintaining organ perfusion to ensure viability and functionality after transplantation. To this end, these patients should be managed in a PICU or a neonatal intensive care unit (NICU), as these units have the necessary staff and technological resources.

In the process of BD, physiological changes take place that may alter perfusion and organ function, and these must be known, detected and managed. Chief among them are the so-called “catecholamine storm”, vasoplegia, hypotension, diabetes insipidus, arrythmia, the release of inflammatory mediators, electrolyte imbalance, acid-base imbalance and hypothermia. Respiratory support is essential to maintain oxygenation and ventilation, striving to avoid the potential lung damage associated to mechanical ventilation. Haematologic abnormalities (anaemia, coagulation abnormalities) and renal and electrolyte abnormalities must be managed, especially those associated with neurogenic diabetes insipidus. The prevention and treatment of infection are essential to avoid transmission to the recipient.

The reduced size of the pool of potentially suitable paediatric donors has spurred the development of strategies to increase the possibility of transplantation in children, such as surgical reduction or splitting of organs or living donor transplantation, among others. In this context, controlled pDCD, understood as donation by individuals deceased following an anticipated cardiac arrest, the WLST decision-making process and discontinuation of life support (Maastricht category III),3,4,8 is particularly important (Fig. 1). Table 4 summarises the differences between pDCD and donation after BD.

Figure 1.

Stages of the process of controlled paediatric donation after circulatory death (adapted from Thuong et al.8).

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Donation in special situations

The ONT-AEP document includes a novel section on donation in 2 special situations. On one hand, newborns with neural tube defects incompatible with life in who PPC starts at the time of prenatal diagnosis and continues with labour and delivery care plans, emotional support and counselling for the family, shared decision-making during the life of the child and the grieving process. Such perinatal PPC must include consideration of organ and tissue donation and the activation in conjunction with the TC of the pDCD protocol, taking into account its complexity and any technical challenges (Fig. 2).

Figure 2.

Process of organ and tissue donation in anencephalic newborns.4

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On the other hand, donation in children receiving PPC at home is another novel situation that is controversial and requires a delicate approach. If the parents or legal guardians and possibly also the child (if intellectually and emotionally capable) make their wish to donate express as part of the care plan and reiterate this will throughout the disease, donation may be an option in the absence of contraindications. In this case, the decision to withdraw life-sustaining treatment will always be made beforehand exclusively by the patient, parents and paediatrician in charge. The subsequent evaluation of the suitability of the patient for donation of organs and tissues will be the responsibility of the TC and will occur following and be independent of the decision of WLST. If the evaluation by the TC is favourable and the parents (and, if possible, the child) reiterate a desire to donate, the child will be transferred to hospital for the donation procedure, which will be similar to the process undergone by an inpatient. In all cases, patients and families will offer psychological and spiritual support fitting their preferences, as well as end-of-life PPC (Fig. 3).

Figure 3.

Summary of the process of pDCD in children receiving palliative care at home.4,5

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Routine consideration of donation in children and newborns when their deaths occur in circumstances compatible with donation is an ethical standard that should become a clinical practice standard. This practice does not only increase the availability of organs for transplantation, but also promotes an integrated family- and patient-centred care approach.

We thank the group of experts in bioethics of the ONT: Diego Gracia Guillén, Alicia Pérez Blanco, Teresa Aldabó Pallas, Josep María Busquets Font, Sebastián Iribarren Diarasarri, José Luis López del Moral Echevarría, Fernando Martínez Soba, Montserrat Nieto Moro, José Miguel Pérez Villares, José Ignacio Sánchez Miret, José Antonio Seoane Rodríguez, Alejandro Toledo Noguera.