End-of-life decisions and practices for very preterm infants in the Wallonia-Brussels Federation of Belgium

Premature birth is a major public health issue due to its prevalence, the clinical and ethical questions it raises and the associated costs. In Belgium, an important process of collective reflection was initiated several years ago through the EPIBEL study, which retrospectively reviewed the case files of 525 babies born at gestational ages of between 22 and 26 weeks in 19 perinatal care units between 1 January 1999 and 1 January 2001 [1, 2]. Of the 303 babies who were born alive and admitted to a neonatal intensive care unit (NICU), 128 (40%) had died during their stay in the unit and 175 had survived [2]. A clinical examination carried out at 3 years of age for 89 of the children who had survived showed a survival rate with no physical, neurological or cognitive sequelae of approximately 40% and a survival rate with sequelae of 60%, of whom 28% had a major disability [1]. The observation of frequent, severe long-term morbidity in children who have survived a birth at the threshold of viability concurs with findings from other European studies [3‐5]. It raises two major clinical and ethical questions, which come up again and again: (i) during the perinatal period, whether or not to actively manage a baby born very prematurely, and (ii) during the postnatal period, whether or not to continue a curative treatment plan initiated at birth.

The results of a number of surveys carried out internationally regarding self-reported practices of neonatologists have highlighted a range of opinions and practices concerning which therapeutic approach to adopt, especially during the period of uncertainty between 23 and 25 weeks’ gestation [6‐8]. In view of the uncertain outcomes for these infants and the dilemma involved in maximising their chances of survival while minimising both the impact on future quality of life and any avoidable suffering during the perinatal period, two extreme positions appear to be dominant among healthcare teams: the first is to systematically undertake standby resuscitation to give all babies a chance of survival. The findings of a prospective national study, carried out in Sweden in a cohort of 507 babies who were followed up for two and a half years, appear to support this approach, provided that care is given in highly specialised centres [9]. The results of the Swedish study actually show an increase in survival rates with no increase in the risk of neurodevelopmental sequelae in units practising systematic active management of extremely premature babies, including those between 22 and 24 weeks’ gestation [9]. The second approach is to refer systematically to a protocol in order to make decisions on the basis of a number of predefined, objective criteria (such as gestational age and weight, based on the results of epidemiological studies and/or experience within a department). This option has been adopted in the Netherlands, where the “Groningen Protocol” was developed in 2004 [10]. In France, without going as far as establishing a formal protocol on required practice, a think-tank on ethical aspects in perinatal care has put forward a number of clinical guidelines aiming at trying to reconcile the legal requirements and ethical responsibility [11, 12]. These guidelines stress the importance of the deliberative processes involved in decision making, where decisions to actively manage a baby are based on an individualised assessment of each situation together with colleagues and the parents [13, 14].

In Belgium, the process of reflection that was initiated at national level in the context of the EPIBEL study [1, 2] is continuing in the form of differentiated regional initiatives. In the Flemish Region, since 2014, care-related decisions and practices in situations of extreme prematurity have been set out in a consensus document, which has the status of a protocol [15]. Such a protocol does not currently exist in the Wallonia-Brussels Federation, which has 11 NICUs. In 2013, these NICUs wished to come together to set up a common research project with the aim of working collectively to think through and optimise practices in relation to curative treatment and/or palliative care provided to extremely preterm infants, paying special attention to babies born at the threshold of viability (between 23 and 26 weeks). The purpose of this study was to highlight the similarities and possible areas of variability between the neonatologists at the 11 NIC units in relation to: (i) their attitudes and experiences with regard to care-related decisions and practices in situations of extreme prematurity and (ii) their opinions and wishes relating to standardising and/or legislating for care-related decisions and practices in situations of extreme prematurity.

The results of this survey show a high level of homogeneity and general agreement on principles governing the decisions to initiate (versus withhold) and continue (versus (withdraw) curative treatment, that reflect the current state of knowledge, and are congruent with published guidelines and protocols around the world [15, 16], including the consensus guidelines issued in the Flemish Region of Belgium [17], which recommend individualised decision for care for infants born at 23 to 24 weeks’ gestation.

The results of the survey and the subsequent discussions held within and between the different NICUs also demonstrate that the different teams share a same vision regarding the extent of the parents’ role and responsibility regarding possible end-of-life decisions. Again, this vision is congruent with agreed international recommendations on how to communicate with parents around these extremely complex and painful issues [16]. Whether in the antenatal, perinatal or postnatal period, parents are partners in the decision-making process but are not held responsible for the final decision. In practice, whenever it is possible (in rare cases, the father may be absent and the mother in intensive care and therefore not able to participate), the parents’ feelings, wishes and fears are explored and discussed. Moreover, their opinion and preferences are sought, in a deliberative process which involves the various members of the healthcare team -and only marginally some external advisors, such as the members of an ethics committee or a mobile palliative care unit. In any case, stand-by resuscitation may be performed, in order to allow for sufficient time to reach a consensus for the best possible decision to be taken. However, when the final decision is reached, the responsibility for it lies within the hands of the medical team, not within the hands of the parents, who are usually not invited to sign a formal consent form. This important principle, which fully acknowledges and respects the parents’ vulnerability at a time when their child’s birth and death are nearly concomitant, is shared across the different NICU teams. This principle is congruent with the logic of care, where autonomy goes beyond individual choice and self-determination, but is understood as embedded in meaningful relationships where important decisions in situations of vulnerability and uncertainty may be displaced and deferred to well-trusted experts [18, 19].

Going back to the results of our study, some diversity was found in responses regarding the transition to and provision of palliative care, as well as diversity regarding “active” end-of-life practices, and whether they should be allowed through a protocol or a law. The differences, even though these are not always statistically significant, were dependent on age and number of years of professional experience in neonatology. In fact, it is likely that the newest doctors had not yet faced all the situations mentioned in the questionnaire. As far as palliative care practices are concerned, only half of the respondents were aware of a protocol or standardised procedure within their NICU, and the responses also indicate that differences exist between centres in how palliative care is defined (whether drug related, non-drug related or both). During the discussions around the results of the study, it was stressed however that consistency can exist without a written protocol, particularly in the form of standardised and accepted procedures that are known to everyone. On the other hand, some stressed that it is still difficult to reach a consensus on certain questions, that not all situations can be anticipated and that the reasoning and the protocols would therefore not be applicable to all situations. As regards the involvement of the Ethics Committee in these discussions, emphasis was placed on the unique ethical aspects linked to the highly specialised care provided in NICUs, and on the difficulty of getting the members of an Ethics Committee to intervene within the very short time frame typically available in emergency situations. While palliative care in neonatology units has emerged as an important specific dimension in paediatrics [20], there is still some debate about the best possible practices to support the baby’s comfort while not prolonging its agony once a decision is made to withdraw life-sustaining interventions [21‐23]. The results of our study reflect well the uncertainty inherent to this very complex area of care.

«Active» end-of-life is a difficult concept that may be interpreted differently by different people. It usually refers to the decision to administer drugs at above therapeutic doses with the intention of bringing about death. This is done in response to certain requests for euthanasia made by individuals who are considered to be able to make such a request. In the case of neonates, the question of euthanasia does not arise because the babies are unable to make such a request. «Active» end-of-life practices are in fact prohibited in Belgium. In the context of a palliative care pathway, however, doctors – faced with suffering that is considered intolerable on the part of the baby – may administer drugs to alleviate the baby’s pain, with the risk that these drugs will cause death. The intention here is therefore not to cause death but to alleviate suffering, with the concomitant risk that this will lead to death. Although the terminology varies across time and different contexts, this may be called continuous sedation until death [24].Our results show that continuous deep sedation until death is sometimes performed, after a deliberation process which involves the parents. In fact, the responses to the questionnaire suggest that there are situations where this is perceived as the more Human way of caring for the baby and their parents.

This raises the question of whether or not to standardise and/or legalise a practice which is currently at the margins of what is allowed in Belgium and in other countries. The fact that the desire for a law tended to be expressed by predominantly the youngest neonatologists in our study whereas the majority of the older neonatologists stated that they were uncertain whether or not they wanted a protocol or a law, seems to indicate a need for younger doctors to feel secure about the major decisions that they have to take. On the other hand, it probably reflects a greater awareness, gained through experience, of the individual and complex nature of each situation as well as a greater awareness of the risk resulting from excessively rigid wording that would limit the possibility of adapting decision-making to specific situations. Although some recommendations exist to guide the practitioners in countries such as the Netherlands where the so-called newborn “euthanasia” is allowed [10, 25], this issue certainly deserves further international and interdisciplinary debate, so as to help practitioners and parents come to terms with this extremely difficult issue when it arises.

Our results reflect the uncertainty inherent in the complex and diverse situations that are encountered in this extreme area of clinical practice, and call for qualitative research and expert debates to further document and make recommendations for best practices regarding several “gray zones” of end-of-life care in neonatology, so that high quality palliative care may be granted to all neonates concerned with end-of-life decisions.