Infants
’
Best Interests in End-of-life
Care for Newborns
abstract
BACKGROUND AND OBJECTIVES: Pediatric bioethics presumes that decisions should be taken in the child’s best interest. If it’s ambiguous whether a decision is in the child’s interest, we defer to parents. Should parents be permitted to consider their own interests in making decisions for their child? In the Netherlands, where neonatal euthanasia is legal, such questions sometimes arise in deciding whether to hasten the death of a critically ill, suffering child. We describe the recommendations of a national Dutch committee. Our objectives were to analyze the role of com-peting child and family interests and to provide guidance on end-of-life decisions for doctors caring for severely ill newborns.
METHODS:We undertook literature review, 7 consensus meetings in a multidisciplinary expert commission, and invited comments on draft report by specialists’associations.
RESULTS:Initial treatment is mandatory for most ill newborns, to clarify the prognosis. Continuation of treatment is conditional on further diag-nostic and progdiag-nostic data. Muscle relaxants can sometimes be contin-ued after withdrawal of artificial respiration without aiming to shorten the child’s life. When gasping causes suffering, or protracted dying is unbearable for the parents, muscle relaxants may be used to end a newborn’s life. Whenever muscle relaxants are used, cases should be reported to the national review committee.
CONCLUSIONS:New national recommendations in the Netherlands for end-of-life decisions in newborns suggest that treatment should generally be seen as conditional. If treatment fails, it should be abandoned. In those cases, palliative care should be directed at both infant and parental suffering. Sometimes, this may permit interventions that hasten death.Pediatrics 2014;134:e1163–e1168
AUTHORS:Dick L. Willems, MD, PhD,aA.A. Eduard Verhagen, MD, PhD, JD,band Eric van Wijlick, MSC,con behalf of the Committee End-of-Life Decisions in Severely Ill Newborns of the Royal Dutch Medical Association
aSection of Medical Ethics, Department of General Practice, Academic Medical Centre/University of Amsterdam, Netherlands; bDepartment of Pediatrics, University Medical Center Groningen, University of Groningen, Groningen, Netherlands; andcRoyal Dutch Medical Association, Utrecht, Netherlands
KEY WORDS
neonatal intensive care, clinical bioethics, end-of-life decisions, palliative care
ABBREVIATIONS
DELN—the decision to deliberately end the life of newborns with lethal drugs
EoL—end-of-life
KNMG—Royal Dutch Medical Association NVK—Dutch Pediatric Society
Drs Willems and Verhagen conceptualized and designed the study, carried out the initial analysis, coordinated and supervised the data collection, drafted the initial manuscript, and critically reviewed the manuscript; Mr van Wijlick carried out the initial analyses, coordinated and supervised the data collection, drafted the study, and critically reviewed and revised the manuscript; and all authors approved thefinal manuscript as submitted and agree to be accountable for all aspects of the work.
www.pediatrics.org/cgi/doi/10.1542/peds.2014-0780
doi:10.1542/peds.2014-0780
Accepted for publication Jul 24, 2014
Address correspondence to A.A. Eduard Verhagen, MD, PhD, JD, Department of Pediatrics, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB Groningen, the Netherlands. E-mail: a.a.e.verhagen@umcg.nl
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright © 2014 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE:The authors have indicated they have nofinancial relationships relevant to this article to disclose.
FUNDING:No external funding.
POTENTIAL CONFLICT OF INTEREST:The authors have indicated they have no potential conflicts of interest to disclose.
and caregivers. When prospects are hopeless, end-of-life (EoL) decisions have to be taken with the utmost care. In this article, EoL decisions are medical deci-sions with the effect, or the probable ef-fect, that death is hastened. They include the decision to withhold or withdraw life-sustaining treatment, the decision to administer medication with a potentially life-shortening effect to alleviate pain and suffering, and the decision to de-liberately end the life of newborns with lethal drugs (DELN). The Dutch termi-nology for the latter decision differs from that in North America and many other countries: in the Netherlands, the term“euthanasia”is used for situations in which the patient can voluntarily re-quest death. Because newborns and children cannot make this voluntary request, we use DELN for what others would call neonatal euthanasia.
Building on previous reports, a com-mission of the Royal Dutch Medical Association (KNMG) has issued new recommendations for EoL decisions in newborns, with the aim of reaching a consensus that may be considered normative within the Dutch medicolegal context.1We defined newborns as chil-dren up to age 1 year. In practice, however, the report concerns mostly newborn in-fants up to age 28 days. This article describes the recommendations developed by the Commission and pays attention to some of the contentious elements. The authors were members of the Commis-sion that wrote the recommendations.
In 1992, the Dutch Pediatric Society (NVK) proposed a distinction between newborns who have no chance of sur-vival, and those who may survive, but with a very poor quality of life.2Quality of life was defined as a life of severe suffering, dependent on medical technology, with extremely restricted possibilities for com-munication and self-subsistence. In both situations, the NVK considered withdrawing
a multidisciplinary commission to dis-cuss the reporting of cases of DELN. Among others, this commission intro-duced the idea that continuation of treatment is conditional upon improve-ment (“life on approval”).3 This would justify, or even demand, withdrawing life support when the prognosis is shown to be grim. In 2005, the NVK adopted the so-called Groningen Pro-tocol concerning the ending of life in severely handicapped newborns, who survive in severe suffering without any prospect for improvement.4,5 If these infants do not die after the withdrawal of life support, the active ending of life may be justified under the same con-ditions as stated in the Dutch euthanasia law, obviously apart from the impossible consent of the patient. Soon after, in 2006, the government decided to estab-lish a commission of experts to assess cases of DELN.
This commission, however, in 6 years received just 1 report of DELN, whereas previous studies had led to the expec-tation of ∼20 cases per year.6 This discrepancy can be partly explained by the implementation of a 20-week ultrasound, which would lead to abor-tion in severe congenital anomalies, but also it was suggested that pedia-tricians may have felt that the criteria of the assessment committee were too vague to give them the confidence to report cases of DELN.
This undesirable situation was an im-portant reason the KNMG asked a com-mission to provide guidance on EoL decisions for doctors caring for severely ill newborns.
On the basis of a thorough study of the existing literature, the Commission, consisting of experts in pediatrics, nursing, ethics, and law, held 8 sessions, drafting a report. This draft was then commented on by associations of obstetri-cians, pediatriobstetri-cians, pediatric neurologists,
of Health. Both the NVK and the KNMG decreed afinal version (after a further round of comments) in May 2013.
We will summarize the main findings and advice of the report, following the sequence of events as they usually oc-cur in time after the birth of a child whose prognosis is deemed very poor. In addition, we will define the areas of agreement and difference with stan-dards for EoL care in North America.
EOL DECISION-MAKING
Decisions about withdrawing or with-holding life-supporting treatments are usually made by a team of professionals and the parents of the severely ill newborn. Within the professional team, views may differ on the chances of survival and, more often, on the quality of life if the child survives.7,8The decision that further treatment is becoming futile is therefore not a 1-step decision: it takes time and repeated team discussions to realize that this is the case. In almost all situations, professional teams will be able to reach a consensus despite pos-sible differences. However, if a consensus is unattainable, that should not prevent a decision from being made; the treating physician remains primarily responsible, even within a team.
Their need for time can justify post-poning the decision to withdraw or withhold treatment, but only if this does not increase or prolong the suffering of the child.
It is crucial to inform parents carefully about the possible events after with-drawing or withholding life-supporting treatment and about the palliative care that is available to assure as much comfort as possible for their child.9–11 This often means that the child may be touched by the parents, and that tubes and lines will be removed as much as possible.
If parents and professionals have dif-ferent opinions about the best way to care for the child who eventually will die, clear and repeated exchanges of mutual views (not only information) usually leads to a consensus, however painful. According to the KNMG com-mission, it is crucial that professionals are aware of the parents’ views on death and dying, as these may have a profound impact on their views and emotions.
Usually one second opinion or more will have been obtained before it is accepted that a consensus cannot be reached. If so, parents cannot force professionals to perform treatments that are clearly medically futile. Conversely, parents sometimes withhold permission for treatments that physicians consider mandatory, such as morphine for pain, or sedation for intractable suffering. Physicians may then need to disregard the parents’refusal and start treatment they view as beneficial and necessary.
WITHHOLDING OR WITHDRAWING LIFE-SUPPORTING TREATMENT AND PROVISION OF TERMINAL CARE
In severely ill newborns, treatment is always started in a situation of extreme uncertainty. The first treatment de-cision to be taken is whether to start life support immediately after birth. Even when the chance of survival appears
poor from the outset, physicians have no choice but to start life support, to prevent deterioration and obtain more certainty about the diagnosis and the chance of survival of the newborn (benefit of the doubt). Continuation of life support, in those cases, is condi-tional on subsequent developments in diagnosis and prognosis.
If it becomes clear, therefore, that the child will not survive, or that survival will only be possible with a severely damaged quality of life, then not only the withdrawal, but also the continuation of life-supporting treatment demands justification. The chance of survival, but also the prospects of independence, communication, the burden of a mostly lifelong treatment, and the relations between these factors must be taken into account. If the continuation of life support is no longer in the child’s best interest, it has no further justification. Then life support should be withdrawn.
Two types of life-supporting treatment demand specific attention in this con-text: artificial nutrition and hydration, and respiration support.
The administration of artificial nutrition and hydration must be regarded as a medical form of life support. As a consequence, a judgment that fur-ther treatment has become futile also applies to nutrition and hydration and implies their discontinuation.
This is not without emotional difficulties for those involved. Sometimes the ar-gument is made that giving artificial nutrition and hydration contributes to the comfort of the child, because it prevents feelings of hunger and thirst (this would render the withdrawal in-humane). This, however, is uncertain; continuation, on the other hand, may have complications and may be the cause of a protracted dying process. Withdrawal of artificial nutrition and hydration, ac-cording to this KNMG commission, will not be inhumane if state-of-the-art palliative care is provided.
Some severely ill newborns do not need to be fed and hydrated artificially, but may be breast- or bottle-fed. This is normal basic care that needs to be stopped only if it causes discomfort through choking or dyspnea.
After the withdrawal of treatment, in-cluding withdrawal of artificial nutrition and hydration, the child will certainly die. Clinical experience indicates that the duration of the dying process may be several hours and sometimes as long as several days; however, literature on the subject is very scarce.12–14There is also not sufficient knowledge about pos-sible suffering as a consequence of withdrawing nutrition and hydration. Because it cannot be excluded, physi-cians need to discuss comfort care, including sedation, with parents.
The parents must be thoroughly pre-pared for the withdrawal of respiratory support because they may interpret any change in their child as a sign of suf-fering. It may be necessary to increase the dosages of analgesics and sedatives to prevent postwithdrawal suffering.15–17 Parents need to be prepared and know that the color of their child may change and that breathing may become very irregular and may appear to be difficult (gasping). It is unclear whether gasping causes suffering in the newborn, but it cannot be excluded. Sometimes infants show signs of suffering, such as clutching theirfists or grimacing, making appro-priate palliative measures necessary. Cases have been reported, however, in which optimal palliative care did not provide sufficient relief.15,16,18–20
Two questions may then come up about muscle relaxants: can or should they be continued after withdrawal of re-spiratory support, and, secondly, can or should they be started in children who did not receive them?
The KNMG commission distinguishes 3 possible scenarios:firstly, continuation after withdrawal of respiratory sup-port. This may sometimes be justifiable
cular blocking agents as part of the medical treatment when the decision to withdraw life support is made, but neuromuscular function cannot be restored for several hours, days, or even weeks. In these circumstances, insistence on the restoration of neu-romuscular function by withdrawing blocking agents before the withdrawal of ventilation will delay the termina-tion of life support well beyond the point at which the patient and family have determined that the burdens of such treatments outweigh the prob-able benefits.
The second scenario would be to ad-minister relaxants de novo, in addition to high doses of analgesics and seda-tives, with the aim of stopping pro-longed gasping and potential suffering in newborns who are weaned from the respirator. According to the Commis-sion, this could be acceptable, but it would mean DELN and should, in the Netherlands, be reported to the com-mission of experts.
Thirdly, relaxants are sometimes given to end a protracted dying process, which only adds to the suffering of the parents who have been through a lot of pain already. Even though careful pre-paration of the parents is often suffi -cient for them to support this, in extreme cases the Commission con-siders this reason acceptable for DELN. Again, this should be reported.
TREATMENT OF SYMPTOMS AT THE EOL
Often, severely ill newborns need med-ication for pain and other symptoms. Even though a proportionate use of opioids and other drugs will almost never shorten the life of the patient, physicians should always take into account this possibility and prepare the parents for it. It is completely
the KNMG commission, this should never lead to disproportionate dosages as a means of ending the suffering of the patient.
Palliative sedation, the intentional and proportional lowering of conscious-ness in a patient who has otherwise intractable symptoms, may be an ap-propriate way to relieve the suffering of a dying newborn. It is a solution of the last resort. The drug of choice is midazolam, sometimes combined with propofol or esketamin. Dosages for very young children are unknown, but should be increased until the symptoms subside.
The last and most contentious decision at the EoL in newborns is deliberately ending it.4 In the Netherlands, each case of DELN has to be reported for review to a national commission of experts that, in view of the general prosecuting office’s decision to prose-cute or not, assesses retrospectively whether the case followed a set of conditions deduced from the euthanasia law. DELN, in our commission’s view, is acceptable in cases of severe suffering that cannot be relieved by excellent palliative care including sedation or, as mentioned above, in exceptional cases of a protracted dying process that becomes unbearable for the parents. Examples could be asphyxiated newborns who remain restless under sedation or newborns who have epidermiolysis bullosa.
There is a small but particularly difficult group of newborns who have serious illnesses who remain stable after life support has been withdrawn or with-held to let the child die. These children do not appear to be suffering and are not dying. DELN would not be justifiable under Dutch regulations. These chil-dren have to wait for a complication such as a pneumonia to be allowed to
fi
that they may become very rare if the recommendations issued by our Com-mission are acted on.
DISCUSSION
This report about EoL decision-making in newborns is largely compatible with currently accepted practices in North America and many other countries in the industrialized world. American ethics and law recognize the rights of all patients or surrogates to refuse any medical treatment, even if life sus-taining, if the patient or surrogate believes that the burdens of treatment exceed the benefits. This is true for the 2 treatments that were highlighted in our summary (mechanical ventilation and medical nutrition/hydration), but is also true for a variety of other life-sustaining interventions, such as di-alysis, transplantation, pacemakers, and others.11,22,23 In addition, US law and ethics also support the practice of palliative sedation for patients of all ages, meaning that patients whose pain and suffering cannot be controlled with standard palliative care treat-ments may be sedated to the point of unconsciousness.24,25The ethical jus-tification for that approach, commonly used by doctors in the United States, is the doctrine of double effect, which permits actions that may hasten death, so long as the intention of the caregiver is to relieve the patient’s pain and suf-fering, not to cause death. This principle also defines the general legal stance in North America.
Thefirst area in which the guidelines from the report differ from North American practice is the authority of parents and surrogates in the Netherlands. The views of parents should be taken into account, but cannot be decisive. Withdrawing or withholding life-supporting treatment is considered a medical decision, fully with regard to survival and at least partly with regard to quality of life. Criteria to value the expected quality of life have been formulated by multi-disciplinary working groups to help physicians and parents decide.2,3,26 Physicians’stewardship of the scarce resources of NICU beds and technology does not play a role. In contrast, in North America, physicians’ roles in determining what constitutes an ac-ceptable quality of life is very limited and physicians do not have the author-ity to make these decisions unilaterally. Court interventions are sometimes sought in these matters and parents are given wide latitude in deciding what quality of life is acceptable for their child.27
The second way that the Dutch devel-opments differ from the North American EoL practices is that they permit the use of interventions even when the intention is clearly to cause the death of the patient, not just to relieve pain and suffering. The Dutch endorse the use of muscle relaxants de novo with the aim of stopping prolonged gasping during ventilator withdrawal and to treat parental suffering by putting an end to a prolonged dying process. This situation may occur occasionally, when even state-of-the-art palliative seda-tion is insufficient to relieve pain and suffering. Such situations may justify, if the parents request it, active ending of the life of the dying newborn by administering muscle relaxants in addition to the analgesics and seda-tives that are already being admin-istered. All cases must be reported for review, to maintain full trans-parency and accountability. The North American view is that muscle relax-ants should never be administered de novo to a terminally ill patient,
because they do not have any sedative or analgesic properties and it is im-possible for the clinician to be intending to relieve pain and suffering if that is not a pharmacological property of the drug.25
CONCLUSIONS
The significance of this document is twofold. First, the document has con-siderable legal standing because NVK and the KNMG have endorsed it, which means that this document expresses the opinion of the medical profession. In the absence of formal legislation, ju-dicial decisions will be primarily based on the medical profession’s opinion. Second, the retrospective legal as-sessment imposes the risk that doc-tors are being accused of murder or manslaughter if they provide DELN, which may drive them to under-report. This may be a less serious impediment to the reporting if the conditions that justify DELN are described in great de-tail and publicly acknowledged by the medical profession.
REFERENCES
1. Royal Dutch Medical Association (KNMG). Medische beslissingen rond het levenseinde bij pasgeborenen met zeer ernstige afwijkingen[Medical End-of-Life Decisions In Newborns With Severe Handicaps]. Utrecht, Netherlands: KNMG; 2013
2. Nederlandse Vereniging voor Kindergeneeskunde. Doen of laten. Grenzen van het medisch handelen in de neonatologie[To Treat or Not to Treat? Limits for Life-Sustaining Treatment in Neonatology]. Utrecht, Netherlands: Den Daas; 1992
3. Overleggroep toetsing zorgvuldig medisch handelen rond het levenseinde bij pasgeborenen. Toetsing als spiegel van de medische praktijk [Assessment as mirror of medical prac-tice]. Rijswijk, Netherlands: Ministerie van Volksgezondheid Welzijn en Sport; 1997 4. Verhagen E, Sauer PJ. The Groningen
protocol—euthanasia in severely ill newborns. N Engl J Med. 2005;352(10):959–962 5. Sheldon T. Dutch doctors adopt guidelines
on mercy killing of newborns.BMJ. 2005; 331(7509):126
6. Verhagen AA. The Groningen Protocol for newborn euthanasia; which way did the slippery slope tilt?J Med Ethics. 2013;39(5): 293–295
7. de Vos MA, van der Heide A, Maurice-Stam H, et al. The process of end-of-life decision-making in pediatrics: a national survey in the Netherlands. Pediatrics. 2011;127(4). Available at: www.pediatrics.org/cgi/content/ full/127/4/e1004
8. Verhagen AA, de Vos M, Dorscheidt JH, Engels B, Hubben JH, Sauer PJ. Conflicts about end-of-life decisions in NICUs in the Netherlands.Pediatrics. 2009;124(1). Avail-able at: www.pediatrics.org/cgi/content/full/ 124/1/e112
9. Batton DG, Barrington KJ, Wallman C; American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee. Prevention and management of pain in the neonate: an update. Pediatrics. 2006;118(5):2231–2241
10. De Lisle-Porter M, Podruchny AM. The dying neonate: family-centered end-of-life care. Neonatal Netw. 2009;28(2):75–83
11. Bell EF; American Academy of Pediatrics Com-mittee on Fetus and Newborn. Noninitiation or withdrawal of intensive care for high-risk newborns.Pediatrics. 2007;119(2):401–403 12. Hellmann J, Williams C, Ives-Baine L, Shah
PS. Withdrawal of artificial nutrition and hydration in the neonatal intensive care unit: parental perspectives.Arch Dis Child Fetal Neonatal Ed. 2013;98(1):F21–F25 13. Miraie ED. Withholding nutrition from seriously
ill newborn infants: a parent’s perspective. J Pediatr. 1988;113(2):262–265
14. Diekema DS, Botkin JR; Committee on Bioethics. Clinical report—Forgoing medi-cally provided nutrition and hydration in children.Pediatrics. 2009;124(2):813–822 15. Burns JP, Mitchell C, Outwater KM, et al.
End-of-life care in the pediatric inten-sive care unit after the forgoing of life-sustaining treatment. Crit Care Med. 2000;28(8):3060–3066
(5):773–785, xii [xii.]
17. Abe N, Catlin A, Mihara D. End of life in the NICU. A study of ventilator withdrawal. MCN Am J Matern Child Nurs. 2001;26(3): 141–146
18. Moratti S. Ethical and legal acceptability of the use of neuromuscular blockers (NMBs) in connection with abstention decisions in Dutch NICUs: interviews with neonatologists. J Med Ethics. 2011;37(1):29–33
19. Perkin RM, Resnik DB. The agony of agonal respiration: is the last gasp necessary? J Med Ethics. 2002;28(3):164–169 20. Kon AA. Palliative sedation: it’s not a panacea.
Am J Bioeth. 2011;11(6):41–42
end of life.N Engl J Med. 2000;342(7):508–511 22. Tripp J, McGregor D. Withholding and withdrawing of life sustaining treatment in the newborn.Arch Dis Child Fetal Neonatal Ed. 2006;91(1):F67–F71
23. Staatssecretaris van Volksgezondheid Welzijn en Sport en de minister van Justitie. Brief van July 29, 2005 aan de Tweede Kamer. Kamerstukken. Vergaderjaar 2005–2006. 30300XVI. Nr 90. Den Haag: Ministerie van Volksgezondheid, Welzijn en Sport en de minister van Justitie
24. Quill TE, Byock IR. Responding to Intractable Terminal Suffering.Ann Intern Med. 2000; 133(7):561–562
in the intensive care unit: a consensus statement by the American College [cor-rected] of Critical Care Medicine.Crit Care Med. 2008;36(3):953–963
26. KNMG Commissie Aanvaardbaarheid Levensbeeindigend handelen. Medisch handelen rond het levenseinde bij wilsonbekwame patiënten. Houten: Bohn Stafleu Van Loghem; 1997
DOI: 10.1542/peds.2014-0780 originally published online September 22, 2014;
2014;134;e1163
Pediatrics
Dick L. Willems, A.A. Eduard Verhagen and Eric van Wijlick
Infants' Best Interests in End-of-life Care for Newborns
Services
Updated Information &
http://pediatrics.aappublications.org/content/134/4/e1163
including high resolution figures, can be found at:
References
http://pediatrics.aappublications.org/content/134/4/e1163#BIBL
This article cites 21 articles, 12 of which you can access for free at:
Subspecialty Collections
dicine_sub
http://www.aappublications.org/cgi/collection/hospice:palliative_me Hospice/Palliative Medicine
http://www.aappublications.org/cgi/collection/ethics:bioethics_sub Ethics/Bioethics
following collection(s):
This article, along with others on similar topics, appears in the
Permissions & Licensing
http://www.aappublications.org/site/misc/Permissions.xhtml
in its entirety can be found online at:
Information about reproducing this article in parts (figures, tables) or
Reprints
http://www.aappublications.org/site/misc/reprints.xhtml
DOI: 10.1542/peds.2014-0780 originally published online September 22, 2014;
http://pediatrics.aappublications.org/content/134/4/e1163
located on the World Wide Web at:
The online version of this article, along with updated information and services, is
by the American Academy of Pediatrics. All rights reserved. Print ISSN: 1073-0397.
