PEDIATRICS Vol. 118 No. 2 August 2006, pp. 563-569 (doi:10.1542/peds.2005-1615)
ARTICLE |
Restriction of Ongoing Intensive Care in Neonates: A Prospective Study
a Department of Pediatrics and Adolescent Medicine, Division of Neonatology, University of Freiburg, Freiburg, Germany
b Institute for Applied Ethics and Medical Ethics, University of Basel, Basel, Switzerland
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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OBJECTIVE. The purpose of this work was to record the current practice of restricting ongoing intensive care in severely ill newborns.
METHODS. This was a prospective observational study over a 30-month period of consecutive newborns for whom restriction of ongoing intensive care was taken into consideration, discussed, or decided on. A standardized form recorded patients' medical condition, the type of restriction decided on, parents' wishes, and their information level. The research was conducted in a neonatal unit of a level III university children's hospital, with no interventions.
RESULTS. Forty patients were enrolled, 25 were preterm, 21 had either a genetic defect or an inborn malformation. Restriction of ongoing intensive care was decided on for 32 patients with a great variety of specified recommendations. Thirty-six patients died during the observation period. In general, parents were well informed; however, their wishes concerning restriction of ongoing intensive care were unknown in 
25% of cases.
CONCLUSIONS. The decision-making process for restriction of ongoing intensive care is well established, but the role of parents needs to be defined.
Key Words: medical ethics • newborn • palliative care • euthanasia • intensive care
Abbreviations: RIC—restriction of ongoing intensive care • CPR—cardiopulmonary resuscitation
There is a growing debate on ethical issues in neonatology, especially concerning the intensive care of severely ill term or preterm infants. In countries with a highly developed health care system, these infants receive resource-intensive treatment, which sometimes has a doubtful outcome. Guidelines concerning policies of active treatment versus the withdrawal of curative therapy, renunciation of resuscitation in the delivery room, and general rules for the treatment of extremely preterm infants at the lower margin of viability vary greatly from one country to another and even between institutions in the same country.
Deciding whether or not to limit or terminate life-sustaining treatment is a great challenge in clinical practice. However, there are few systematic studies on the restriction of ongoing intensive care (RIC) in neonates, integrating both ethical and clinical issues. The majority of studies rely on self-report methods.
We conducted a study to analyze the conditions on which decisions regarding RIC are currently made in our NICU. Our objective was to give a direct insight into clinical and ethical decisions regarding the question of how far life-sustaining measures are continued and under which conditions a shift toward palliative care is preferred. We were interested to find out whether the decisions respected or went beyond the legal and ethical limits of permissible end-of-life care or whether they did not use the options of shifting toward palliative goals.
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METHODS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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The study was conducted at the University Children's Hospital Freiburg, a level III NICU with a total of 20 neonatal cots on 2 wards and
550 neonatal patients in the whole neonatal unit per year. In this prospective study, term and preterm newborns were recorded for whom RIC was taken into consideration, discussed, or decided. Patients where we refrained from cardiopulmonary resuscitation only at a terminal stage of dying or who were then taken off the ventilator but had not met inclusion criteria before were not considered. The approach followed the method of the "embedded researcher," which allows for a combination of methods of systematic observation and case documentation in a naturalistic setting.1 For this purpose, a structured documentation chart was developed by the medical ethics team. This form addressed the following issues: (1) medical history as documented in the medical charts: diagnosis, course of illness, and prognosis of the disease(s); (2) situation of the parents as decision-makers for their child: information level, capability to decide, wishes, and involvement in the decision-making process; and (3) process of discussion and decision-making within the professional team. The form combines fixed and open questions; it was filled out by the embedded researcher trained to gather information in a standardized way based on oral inquiry of staff and written resources, such as patient's records. It is general practice at the institution to hold ethics rounds on particular patients. The ethicists were not directly involved in any of the cases in the study, neither in the ethics consultation nor in the decision-making process, to ensure that the clinical process was described in a naturalistic way. The participants of these ethics rounds were: the head of the pediatrics department, the head of the neonatal unit or his deputy, a resident doctor, a nurse, and occasionally an experienced consultant for a specialist field (eg, child neurology or oncology), respectively.
The embedded researcher from the Institute of Medical Ethics participated as an observer, taking notes, which were evaluated separately. This methodologic concept ensures that the documentation procedure does not interfere with discussion or decision-making; this implies taking an ethically neutral position, that is, not giving ethical comments or advice during the research phase. Patients were recorded during a 30-month period between 1998 and 2000.
The study allows for a quantitative data analysis with a clinical focus as is shown in the tables. Qualitative analysis focusing on ethical issues is to be conducted on a case-by-case basis; publication will need more space than is available here.
Before carrying out the study, the protocol was submitted to the local research ethics committee, which agreed that no formal evaluation was necessary, because neither patients nor parents were confronted with any additional or unusual procedures for the study, and the embedded researcher only contacted the ward staff. This approach had been made a precondition to the study by the chief clinician who wanted to avoid any irritations of routine for patients and parents.
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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There were 1295 patients admitted to the unit during the study period, of which 59 died. Forty consecutive severely ill patients were recorded and analyzed, allowing for both a descriptive statistical data evaluation and a deeper ethical analysis on a single case basis. Twenty-five patients were preterms, 10 had a birth weight of
1000 g, and 8 were twins. Twenty-one patients in the whole group had either a genetic defect or an inborn malformation, and 11 had a severe intraventricular hemorrhage. RIC was discussed and applied in 32 patients and discussed but not applied in 4 patients. RIC was not discussed in 4 patients, although an ethical problem was claimed; in 2 of these cases, the infants died before an ethics round could be called; in 1 case, the medical condition improved unexpectedly quickly; and in 1 case, the discussion was started on an obviously false assumption, thus making an ethics round unnecessary in these latter 2 cases. Three infants for whom RIC had been decided on went home; 2 of them died there and 1 survived 
1 year. Three of 4 infants for whom RIC had been discussed but not applied went home, and the fourth infant died in the NICU. Patients' characteristics and main diagnoses are given in Table 1. A total of 243 diagnoses were recorded, so, on average, each patient had 6 diagnoses.
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The restrictions, as opted for by the team, and the foundation for them are summarized in Table 2. Twenty-six decisions on RIC were made because of futility of therapy; in 3 cases, an intervention was withheld because of severe congenital malformation, genetic defect, or inborn error of metabolism, and in only 3 cases were there serious concerns about the quality of life.
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The wishes and attitudes of the parents were written down as perceived by the medical staff in informal talks with parents and are either cited word-by-word or "translated" later during analysis of the data into generic terms by the embedded researcher (Table 3). The definite wish of the mother or father was known in 77% and 72% of the cases, respectively; in 9 cases, neither the father's nor the mother's wish was explicitly stated. In 33 (82%) of 40 cases, the parents (or mother/father, if only 1 parent was caring for the infant) were informed about the professional team's decision and about the reason for RIC. In 4 cases (10%), they were not informed in detail, mainly because the decision was made on an emergency basis (2 cases), the decision was still open (1 case), or important diagnostic results were still missing (1 case). In 3 cases, information on this issue could not be extracted from the patients' charts or by asking the staff members available. The position of parents concurred more or less with the recommendations of the ethics round; in no case was there a strict opposition to the group's decision.
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Fourteen infants died in their first week of life, 9 in week 2 to 4, 7 in week 5 to 12, and 4 after week 12. Six patients were discharged from the hospital, and 2 of them died later.
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Clinical ethics raises general issues relevant for both adult and pediatric health care. Issues that are addressed are: (1) chances and risks of therapies, (2) probability of survival or permanent handicap, (3) usefulness of intensive care medicine, (4) utility of curative versus palliative care, and (5) euthanasia. However, the background on which these ethical questions are addressed differ as described below.
A neonatal patient will always be viewed differently from an adult patient or an older child, probably because the fundamental right to comprehensive medical therapy that is indisputable in the case of an adult patient or older child is under debate if the patient is a newborn infant; this may put the neonatal patient at disadvantage. Parents are entitled to decide about the treatment of their infant; practicing this right, they are obliged to consider the best interest of their child. This obligation is laid down in German law and may compensate the disadvantage of infants who cannot benefit from advance directives6 or chose their surrogate decision-makers.7
A neonate has a paramount capability to develop a great variety of abilities but is also more vulnerable to organ damages, which, in turn, makes all kinds of prognoses uncertain.8 If the decision is to continue rather than to restrict therapy and if a severe disability is the final outcome, this will have a great impact on the whole family. Parents anticipating such outcomes may have difficulties considering the infant's best interest adequately; it is debatable how far parents should have the privilege to prioritize their own interests against the hypothetical interest of the child. These are some aspects in which ethical considerations differ to some extent between neonatal and adult patient care.
In the past, systematic studies on decision-making in the field of neonatology were most often done by sending questionnaires to neonatologists to assess their personal attitude to real or hypothetic cases.2,5,9 To provide a more realistic and valid empirical basis for ethical analysis and clinical ethics consultation in this realm, we studied the decision-making process on the ward within the clinical team, as well as the wishes of the parents prospectively.
Most studies dealing with RIC in neonatology looked at deaths in the NICU and then identified retrospectively the immediate cause of death, and, in fact, RIC was predominant.10–12 In 2 prospective studies from France, 50% of deaths of infants <32 weeks' gestation occurred after withholding or withdrawing therapy,13 and 54% of pediatric patients (with premature infants excluded) died after withdrawal of therapy or on the basis of a do-not-resuscitate order.14 In retrospective studies from the United Kingdom, New Zealand, the United States, Canada, and the Netherlands, rates of death with concomitant RIC were also in a range between 50% and 75%.3,10,11,15–17
Our aim was not to limit the study to fatal cases but rather to record all situations on the NICU where 1 member of the team articulated an ethical issue regarding continuation or restriction of treatment and then to follow the decision-making process, also in regard to the parents' situation. A similar question had already been studied in 1986 by Whitelaw,18 but he did not use the methodologic basis of the embedded researcher approach1 and did not put emphasis on the parents wishes.
Our study indicates that, with a frequency of 40 per 1300 admissions on a level III neonatal unit, discussions with an ethical background concerning RIC are held. Making critical treatment decisions in an extremely hopeless situation affects (1) patient or family autonomy, (2) legal aspects,19 and (3) the question of medical resources. Our discussion addresses parents' autonomy only.
In former decades, decisions concerning withdrawing or withholding treatment from severely ill neonates were "quiet decisions" made by the physician in charge. In 1973, Duff and Campbell20 worked out the ethical dilemma of this common practice. As a result, this issue became a topic of controversial discussion.
The attitude of neonatologists toward intensive care in general and toward particular measures, like ventilator support, varies over time and obviously must take the latest results into consideration.21 Most importantly, RIC decisions differ greatly between European countries and are influenced by the physicians' age, experience, and general attitude.22 The decision reflecting the greatest differences in the study by Cuttini et al22 concerned practice of active euthanasia. These differences would probably turn out to be relevant in a worldwide survey, as well.
According to a critical comment by Steinberg,23 the former principle of "paternalism" exerted by the physician has now been replaced by paternalism exerted by the parents. However, this comment does not acknowledge the legal and ethical status of the parents' right and duty as decision-makers of their child.24,25 Obviously, the principle of respect for the autonomy of the patient himself/herself is generally not applicable to decisions concerning sick neonates. Rather, we must respect the wishes of the parents as long as they do not conflict with the patient's best interest. Comparable variables, as mentioned for neonatologists, affect decision-making by parents; their ethnocultural and religious background is more important than their own experience.26 However, other persons or institutions who might act as surrogate decision-makers for the newborn infant in lieu of the parents, such as the whole medical team, the courts, religious leaders, or others, are also contestable. It is sometimes claimed that the best choice is probably an ethics round if the members are experienced and adequately familiar with the situation of newborns.23
Currently, nationwide "ethical discussions" on critical treatment decisions in neonatology focus on guidelines regarding extremely premature infants at the lower margin of biological viability.2,27,28 In our study, however, this group of infants was far less often the focus of RIC discussions than is commonly thought. Patients with multiple diagnoses were predominant, and this fact makes discussions on RIC more complex and difficult, because different aspects of diseases with their unforeseeable interrelationship must be considered.
Interestingly, the list of RIC decisions as applied in this study resembles very much that of the European survey on RIC decisions by Cuttini et al,22 except for the administration of drugs with the purpose of terminating life, which has never been practiced in our unit. This list also resembles that of a study by Pierucci et al,29 except for withholding or withdrawing fluids or feedings, which was not discussed in our unit and remains a controversial issue in ethical discussions.23 The fact that the list is very long may reflect the wish of the professional team to tailor an individual order for RIC to each patient.
The withdrawal or withholding of mechanical ventilation is a frequent RIC decision,22,29 but the possibility of adverse reactions, such as shortness of breath or the feeling of suffocation, has not been systematically studied. This problem is probably overcome by large doses of central analgesics or sedatives, a practice deemed permissible as "indirect euthanasia" by German law, but is difficult to separate from the intended termination of life ("active euthanasia"), which is prohibited and may, therefore, be rarely reported. According to the study by Singh et al,12 we attempted to catalog RIC according to the 2 potential categories: futility in a "physiologic sense" and concern about the ultimate neurologic outcome in a more "ethical sense;" in most patients, the application of RIC was founded on futility.
In a Dutch study, the term "death appears inevitable" represented the foundation of RIC in 98 of 181 cases of dying after RIC, so a real choice in this situation is unlikely.30 We used the original wording recorded by the ethics rounds to assess the reasons for RIC, which was then grouped into a list of terms with an identical meaning. The term "death appears inevitable" was not mentioned, so, obviously, the discussion on RIC in all cases was begun well before the process of dying began. On the other hand, interpretation of these terms may vary even in a homogenous group of exclusively experienced neonatologists.
The most frequent order for RIC was to refrain from cardiopulmonary resuscitation (CPR). As stated by Davies and Reynolds, "choice between CPR and ‘do not resuscitate’ orders is a ‘chance for life versus certain death,’ but the true choice may be between prolonged, multiple invasive, painful and dehumanising procedures versus a dignified death in familiar surroundings and company, with adequate analgesia."31
All of the patients in this study received adequate doses of sedatives and analgesics as part of the protocol of the institution for ventilated and/or very sick infants. In the end stage of the individual process of dying (ie, during a few minutes before death was attested by verifying cardiac arrest), the last dosage of the continuously infused drugs was doubled or tripled.
When interpreting the rate of parents who were fully informed about the decision-making process, it must be pointed out that the figures given relate to the information obtained from the professional team. Given the delicacy of the situation, we decided not to conduct an additional interview with the parents for research purposes. Thus, the parents' evaluation may differ somewhat from that of the professional team on that point.
The general attitude of the parents toward RIC, to the extent that it was known at all, was expressed by the member of the ethics round who was most familiar with their wishes. The data show that in 9 cases the clinical team had no knowledge of the parents' wishes. On the whole, the wishes of the parents were similar to those of the team. However, because we did not interview the parents, we cannot substantiate that on a case-by-case basis. Wishes for RIC or "humane treatment" prevailed over wishes for "maximum therapy," but there was a significant number of parents who opted against RIC at first glance. It was the task of the neonatologist to explain the background of the team's decision to the parents. In a similar study, it was claimed that parents were "involved in making 79% of decisions," but this was also the interpretation of the neonatologist and was not verified by an interview with the parents.11
The question of whether or not and how parents can participate in the ethics rounds of the ward or in formal ethics consultation should also be discussed.26,32,33 In addition to the idealistic concept of "comprehensive informed consent," the modifications of an "informed confidence" seems to be justified in some cases, when parents feel overwhelmed by the details and ask the physician to share the responsibility with them.
Contrary to a generally held assumption on the part of the physicians, parents do tend to favor medical therapy rather than RIC.34 From a study with a large number of parents in different European countries, we know that parents wish to participate in the decision-making process.25 Because parents are the legitimate decision-makers for their infant, and their parental autonomy must be respected, it seems necessary to know more about their level of information and to decide about their role in RIC decisions. In a future study, parents should be interviewed on these 2 issues. In retrospect, the lack of information on the parents' situation seems to be a major weakness of the study.
It is obvious that specific competence, training, and expertise on how to deal with ethical issues is mandatory for participants of such ethics rounds.35,36 Participants must possess both ethically based decision-making principles, as well as a medical background to judge the question of futility of CPR or maximum therapy in the face of a potentially irreversible process of dying and, what is even more uncertain, the chances of neuromotoric development in the future versus the risk and extent of a permanent handicap.8 There can be a significant difference between assumed survival rate of preterm infants as estimated by physicians and actual data; the same holds true for residual morbidity.37 But even when an ethics round is made up of highly competent participants, fine distinctions between such terms as "no chance of survival" and "poor prognosis"11 must be reflected on very cautiously, because the level of evidence to be judged is difficult to define. RIC can be supported by a palliative care consultation service, where it exists, but it must be mandatory that members of this service be specialized in the field of neonatal medicine and have ethical competence as well. Recommendations given by such a team may well affect care at the end of life for neonates such that the extent of medical procedures is reduced and supportive measures for families are intensified.29
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CONCLUSIONS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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The study presented here describes the current practice of RIC in one single institution. Because there are only a few empirical studies on RIC practice in neonates, it would be worth conducting a collaborative multicenter study, probably involving institutions from different countries to refine the method of ethical case analysis and to analyze the differences in the current practice of decision-making for RIC or other difficult decisions having an ethical background in the field of neonatology. More attention should be focused on the parents' information level and on their involvement in the decision-making process.
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ACKNOWLEDGMENTS |
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This work was supported by the German Research Council (grants Re 701/4-1 and Re 701/4-2 to Dr Reiter-Theil).
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FOOTNOTES |
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Accepted Mar 17, 2006.
Address correspondence to Roland Hentschel, MD, Department of Pediatrics and Adolescent Medicine, Division of Neonatology, University of Freiburg, Mathildenstrasse 1, 79106 Freiburg, Germany. E-mail: roland.hentschel{at}uniklinik-freiburg.de
The authors have indicated they have no financial relationships relevant to this article to disclose.
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