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Neonatal care: withholding or withdrawal of treatment in the newborn infant
Baillière’s Clinical Obstetrics and Gynaecology Vol. 13, No. 4, pp 503–511, 1999
B A I L L I È R E ’ S
4
PRACTICE & RESEARCH
BEST
Neonatal care: withholding or withdrawal of treatment in the newborn infant John S. Wyatt
FRCP, FRCPCH
Professor of Neonatal Paediatrics University College London, 5 University Street, London WC1E 6JJ, UK
Life-sustaining treatment may be ethically withdrawn or withheld in critically ill or dying newborns if the action is genuinely in the best interests of the patient. This may occur in situations where life-sustaining treatment is futile because of a hopeless prognosis, or if the burdens of intensive treatment clearly outweigh its likely benefits. There is no fundamental ethical difference between the withholding of resuscitation and the withdrawing of life-sustaining treatment once it has commenced. However the actions may have different emotional and psychological implications. A decision to withdraw treatment should only be taken with the consensus of experienced staff caring for the baby and with the unpressurized agreement of the parents. Palliative care and symptomatic relief should always continue after life-support has been withdrawn. Emotional and practical support should be provided for parents and adequate training and support is essential for obstetric and neonatal unit staff. Key words: newborn human infant; selective withdrawal of treatment; extreme prematurity.
The remarkable development of neonatal intensive care over the last 20 years has led to acute clinical and ethical dilemmas for paediatricians, obstetricians and parents alike. The survival of extremely preterm infants born at less than 26 weeks gestation and weighing less than 750 g is now commonplace. A wide range of techniques to prolong life are now available for many infants with severe and previously untreatable congenital malformations. These technological advances have led to complex dilemmas for medical staff and parents. Should an attempt be made to resuscitate all premature babies however immature or severely malformed? Once intensive care has commenced, is it ethical to withdraw treatment in a baby whose prognosis is extremely poor? To what extent should the wishes of parents influence clinical decision-making in this complex and difficult area? In this chapter I shall aim to address these issues from the perspective of a practising neonatologist. ACTING IN THE PATIENT’S BEST INTERESTS The mainstream tradition of Western medical ethics, which is derived ultimately from Hippocratic sources, enshrines a fundamental orientation towards the protection and preservation of life, combined with a duty to protect the individual from harm. A recent report of the Royal College of Paediatrics and Child Health on the withdrawal of life saving treatment (RCPCH, 1997) defined the primary intention of the Health 1521–6934/99/040503 + 09 $12.00/00
© 1999 Harcourt Publishers Ltd.
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Care Team as ‘sustaining life and restoring their patients to health’. Yet the existence of sophisticated life-support technology means that it is possible to sustain life in circumstances where medical treatment seems to bring little or no benefit to the individual patient. In addition, invasive and intensive treatment can cause great suffering to the child, emotional trauma to the parents and family, and it can lead to the expenditure and diversion of scarce health resources for little obvious purpose. Although resource issues cannot be ignored, they must not be allowed to dominate the discussion. Central to all decisions about the appropriateness of life-sustaining treatment must be the ethical duty of care of the clinician and child health team; that is to act in the best interests of the individual child. Within this ethical framework, it is possible to conceive of a number of situations in which life-sustaining treatment should be withheld or withdrawn. The recent report of the Royal College of Paediatrics and Child Health (RCPCH, 1997) has suggested a number of scenarios in which treatment might be withdrawn from children and newborns, summarized under the following headings: the brain-dead child, the permanent vegetative state, the ‘no chance’ situation, the ‘no purpose’ situation, the ‘unbearable’ situation. In neonatal practice, I wish to suggest that these situations can be summarized under two headings: first, clinical conditions in which treatment is futile, and second, situations in which invasive medical treatment is excessively burdensome, relative to its possible benefits. WHEN LIFE-SUSTAINING TREATMENT IS FUTILE In the context of neonatal care, intensive care treatment can be regarded as futile if there is no possibility of long-term survival, as with an extremely preterm infant with an accurate gestational age of less than 22 weeks, or in the presence of a proven lethal malformation such as Trisomy 18 or anencephaly. In such cases it seems appropriate to withhold all intensive life-sustaining treatment and to provide palliative care and symptomatic treatment with the expectation that death will follow. Similarly, if a baby who is undergoing intensive care deteriorates irreversibly so that they are in the process of dying despite maximal treatment, then it is ethically appropriate to withdraw life-sustaining treatment in the recognition that death is inevitable. There is no ethical duty on physicians to provide medical treatment which has no possibility of success, nor is there a duty to prolong the process of dying. WHEN LIFE-SUSTAINING TREATMENT IS EXCESSIVELY BURDENSOME If the physician has a duty of care to act in the patient’s best interests, then it is essential that the benefits and burdens of each form of treatment be assessed to ensure that the expected benefits outweigh the burdens. There is no ethical duty on physicians to provide treatment whose burdens outweigh the possible benefits. Indeed the commencement or maintenance of treatment that can bring no benefit to the patient, may be viewed as a form of assault or abuse, and is clearly contrary to good ethical practice. From this perspective neonatologists must be prepared to withhold or withdraw intensive support in babies in whom the burdens of treatment outweigh the likely benefits. How might these concepts be translated into clinical practice? In the extremely preterm infant born in good condition at 24 or 25 weeks of gestation with
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an apparently normal brain, the burdens of several months of intensive care treatment are likely to be outweighed by the long-term benefits of the treatment. Conversely, in the infant born at an identical gestational age who is in very poor condition, with bilateral parenchymal cerebral haemorrhages or widespread periventricular leukomalacia, the potential benefits that prolonged intensive care may bring are dramatically reduced, and hence the withholding of intensive treatment may be appropriate. Similarly, the curative potential of intensive care in an infant with respiratory failure together with a profound congenital malformation such as thoraco-lumbar spina bifida and hydrocephalus, is likely to be considerably reduced compared with a child who has respiratory failure but no underlying malformation. The burdens of treatment may be similar in both cases but the potential benefits are significantly reduced in the first case. As a result it may be appropriate to withhold prolonged intensive care for the child with very severe fetal malformations because of the reduced benefits that such care can bring. Clearly the balancing of burdens and benefits will depend on the individual clinical circumstances and will necessarily involve a degree of subjectivity. As a result it is essential that these difficult decisions are discussed with clinical colleagues and with parents, so that wherever possible a consensus may emerge. If life-sustaining treatment is withheld in cases where major congenital malformations are present, it should be clear that this is genuinely in the patient’s best interests, that is that the burdens of treatment are clearly excessive, rather than due to a covert prejudice that the lives of disabled people are somehow of less value to themselves or to society. It has been frequently suggested, both by ethicists and by clinicians, that some kind of ‘quality of life’ criteria should be used to decide whether the continuation of intensive care is worthwhile (Kuhse and Singer, 1985; Whitelaw, 1986; Chiswick, 1991). Some ethicists have gone further and argued that certain lives have a negative value; in other words that death is always preferable to certain forms of living in a disabled state (Glover, 1977; Kuhse and Singer, 1985; Singer, 1995). But it is not at all obvious on what basis these value judgements are made and other ethicists have challenged this concept. Paul Ramsey, for example, argues that it is not appropriate for us as mere human beings to judge the quality of other people’s lives, and in any case we are quite incapable of doing it adequately (Ramsey, 1978). Richard Higginson also argues that it is inappropriate to allow doctors to use ‘quality of life criteria’ in making decisions about life-sustaining treatment (Higginson, 1987). Higginson states that he is prepared to trust a doctor’s competence in medical judgements such as the distinction between when a patient is living or dying. However ‘. . . where neither he [Ramsey] or I are prepared to trust a doctor’s competence is when they presume to judge whether a person’s life is worth living’ (Higginson, 1987). This criticism has force and it highlights the pitfalls inherent in the medical judgement of the quality of life. As Higginson argues, it is not obvious that doctors have any special expertise that allows them to presume to judge the ultimate value or significance of another human life. I wish to argue that within the context of traditional medical ethics, the doctor’s role is to assess and balance the relative value of different treatment options, rather than to assess the relative value of an individual’s life compared with other lives. In my view, the doctor may determine whether a treatment is futile or valueless, but the doctor can never determine whether an individual life is futile or valueless. Like Ramsey and Higginson, I do not believe that doctors are better equipped than anyone else to decide the ultimate value of another person’s life. Where they do have special expertise is in the balancing of the burdens and benefits of different forms of medical intervention.
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THE INFANT WITH SEVERE BRAIN INJURY One of the most difficult decisions facing the practising neonatologist is whether lifesustaining treatment should be withdrawn from the infant undergoing intensive care who has evidence of severe and irreversible brain injury. What criteria should be used to guide clinical decisions in this situation? The traditional diagnoses of brain-stem death and the permanent vegetative state cannot be reliably determined in the newborn, and these diagnostic categories should not be employed. Before withdrawal of support can be contemplated it is important to obtain as much objective information about anatomical damage and functional impairment of the central nervous system as possible. This may include a structured neurological examination, cranial ultrasound scanning, neurophysiological measurements and, where possible, computerized tomography (CT) or magnetic resonance (MR) imaging of the brain. The prognosis for neurodevelopmental outcome should be discussed in detail with the parents, recognizing that even when detailed information about the brain is obtained, there is always a degree of uncertainty in the long-term prognosis. This information can then be used to weigh against the burdens of prolonged intensive care and other medical treatments that may be required in the future. In my view the most critical capacity for assessing the likely benefits of treatment is that for loving and interactive human relationships. Brain injury that causes impaired mobility or loss of visual or auditory function, whilst capacity for loving relationships is retained, is very different from injury of such severity that no relationships are possible. Whilst the presence of such brain injury would not prevent the infant from being regarded with respect and dignity, it does raise questions about the appropriateness of prolonging survival by intensive medical and technological support. In such cases the burdens of intensive care can be seen to outweigh the benefits. If such an outcome can be predicted with reasonable certainty, it is, in my view, ethically justifiable to withdraw support with the realization that the infant will almost certainly die as a result. In practice, these criteria would imply brain injury of sufficient severity to cause global destruction of cortical and subcortical structures in both cerebral hemispheres. This degree of brain destruction may occur in severe bilateral intraparenchymal haemorrhagic infarction, severe cystic periventricular leukomalacia, or severe hypoxicischaemic encephalopathy. Even with the benefits of extensive investigation, the prediction of long-term neurodevelopmental outcome in the extremely preterm infant is by no means an exact science. The variable response of the immature nervous system to injury and the potential plasticity of neural connections contribute to the unpredictability of longterm outcome. Where there is a substantial degree of uncertainty in the prognosis, it is appropriate to continue intensive support, whilst carrying out regular assessment of the baby’s condition, in the hope that the likely outcome will become clearer. IS THERE A DIFFERENCE BETWEEN THE WITHHOLDING OF INTENSIVE TREATMENT AND THE WITHDRAWING OF TREATMENT THAT HAS BEEN COMMENCED? Clinicians and parents frequently perceive a major difference between the withholding of resuscitation in a critically ill baby at birth, and the withdrawal of life-sustaining treatment after intensive care has commenced and the baby has been transferred to
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an intensive care unit. Neonatologists may feel that it is psychologically much harder to stop treatment after it has been commenced and as a result they may fear that intensive care may be continued in an inappropriate manner. From a medico-legal perspective, clinicians may be concerned that the cessation of intensive care treatment may be regarded as tantamount to intentional killing by legal authorities, and opens them to the risk of criminal charges. Obstetricians may feel that the commencement of resuscitation implies an irreversible and irrational commitment to sustain life whatever the consequences and may worry that the parents are being offered false hope that intensive care can save their child. From an ethical perspective the withholding and the withdrawing of life-sustaining treatment seem to be equivalent. In both cases the intention is to prevent treatment and in both cases the outcome is the same. However from my own experience, there may be psychological benefits from commencing intensive care, even when the chances of long-term survival are slight. Parents who are confronted with the delivery of an extremely preterm baby are frequently concerned that ‘everything possible is done’. If a decision is made not to commence resuscitation, parents may be left with a longlasting anxiety that their child might have survived in other circumstances. A short period of intensive care will reassure the parents that the child has been given the best possible chance of survival, and may allay fears that the baby might have survived ‘if only the doctors had tried harder’. In addition, commencement of life-sustaining treatment and admission to a neonatal intensive care unit may enable a brief time for the parents (and possibly other relatives such as siblings and grandparents) to meet their child. It allows time for baptism, or some other religious ceremony if this is the parents’ wish. It also enables palliative treatment with analgesia and sedatives to be given to prevent any possibility of suffering, and appropriate emotional support given to the parents and other relatives by the neonatal unit staff. If, after a brief period of intensive care, it is obvious that the outlook is hopeless, further discussion with parents should be undertaken and, with their agreement, mechanical ventilation and other therapies can be withdrawn in controlled circumstances. The family should be encouraged to cuddle and grieve for their infant in a private room, with the support of the staff. Despite the pain and grief, many parents gain consolation and comfort from this experience, knowing that everything possible was done for their child. Against these possible benefits must be weighed the appropriateness of using scarce and expensive intensive care resources if the outlook is hopeless. I would argue that the emotional benefit for the parents of meeting their child does justify the use of intensive care resources in these limited circumstances. The capacity for the extremely preterm infant to feel pain remains unclear, but the appropriate use of opiates and sedatives can safeguard against the possibility of suffering. Another argument in favour of commencing intensive care in infants of questionable viability is the possibility of error in the calculation of gestational age. Small variations in gestational age may lead to large differences in the chances of survival. Thus at 22 weeks gestation the chances of survival are virtually nil, whereas 2 weeks later, at 24 weeks, the chances of survival are currently over 50% in many major centres. Gestational age assessment before and after birth is frequently unreliable, particularly where an early antenatal ultrasound scan has not been performed. In such cases it may be appropriate for an experienced paediatrician to assess the baby immediately after birth and to commence intensive care if it seems possible that the baby is more mature than had been anticipated. In effect the baby is given ‘the benefit of the doubt’. After resuscitation the baby should be transferred to a neonatal intensive care unit and thoroughly assessed with particular attention to the lungs, circulation and central
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nervous system, including cranial ultrasound examination. If it becomes apparent that the outlook is hopeless, intensive care can then be stopped after full explanation and discussion with the parents. In general it seems far better to make these critical decisions under controlled circumstances in the intensive care unit rather than in the heat of the moment in the labour ward. If the availability of neonatal intensive care resources is seriously limited, it may not be appropriate to ‘block’ a space in the intensive care unit with a very immature infant who has only a poor chance of survival. This might well lead to the death or injury of more mature infants who are delivered subsequently. Under these circumstances it may be appropriate to withhold resuscitation and intensive care from infants of less than 25 weeks gestation or <750 g birthweight in the expectation that they would die shortly after birth. Obviously it is vital that basic palliative nursing care should be provided to all infants even if intensive support techniques are withheld. (This policy does however raise the remote possibility that an extremely preterm infant might survive despite the withholding of intensive care, but with a greater degree of brain injury.) WHO SHOULD BE INVOLVED IN A DECISION TO WITHDRAW LIFE-SUSTAINING TREATMENT? By far the commonest reason for withdrawing intensive support is the recognition that the infant is dying and that the continuation of intensive care is merely prolonging the process of dying. This stage is usually obvious due to the presence of profound respiratory failure, bradycardia and hypotension despite maximal cardiorespiratory support. The decision to withdraw care may have to be taken as an emergency, and there may be little time to consult with colleagues or with the parents. Unless there is a clear reason for prolonging the phase of dying in order to allow the parents to spend time with the child, there should be a rapid withdrawal of intensive support. Performing prolonged resuscitative efforts in this situation should be avoided at all costs, and wherever possible the baby should be allowed to die in the parents’ arms rather than connected to the panoply of intensive care machinery. Where the withdrawal of intensive care is contemplated despite the fact that the acute condition of the infant is stable, more time is available for detailed discussion. Because of the momentous implications of withdrawing intensive support from such an infant, appropriate safeguards are essential. There should be unequivocal agreement amongst the senior medical and nursing staff involved that global, devastating and irreversible brain injury has occurred, and that the outlook is hopeless. Where possible a ‘second opinion’ from an independent paediatric or neurological consultant should be sought. In the event of major uncertainty about the extent or severity of brain injury, full intensive support should continue. On both ethical and medico-legal grounds the senior clinician carries ultimate responsibility for all medical treatment that is carried out. However, the parents of the child are clearly intimately involved and detailed explanation and discussion with them is essential. Time must be given for the parents to discuss the issues fully and their full and unpressurized agreement to the course of action is essential. Where appropriate, counselling staff, or the hospital pastoral care team, should be involved. If the parents cannot agree to the withdrawal of life-sustaining treatment, intensive care should continue. Further time for unpressurized discussion and explanation with the parents should be given. Ultimately it may be necessary to recourse to the Courts for permission to cease treatment against
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the wishes of the parents, but this is likely to be a lengthy and distressing process, and is rarely necessary in practice. In British clinical practice, resort to an independent ethical committee with executive power to prescribe forms of clinical management does not seem to be a satisfactory way of resolving these difficult ethical decisions in neonatal intensive care (Whitelaw, 1986). PRACTICAL MANAGEMENT OF THE WITHDRAWAL OF INTENSIVE SUPPORT Withdrawal of life-sustaining treatment should take place in an unhurried, private and dignified manner. It may be appropriate to administer an adequate dose of opiate analgesia together with a sedative, such as a benzodiazepine, to avoid any possibility of suffering. The parents should be given time to be alone with their child and suitable facilities for baptism or other religious ceremonies should be provided. When it is appropriate, the infant should be disconnected from the ventilator and other intensive care equipment and should be clothed and wrapped in a shawl or blanket. A private room should be provided to allow the parents to hold their child and express their grief in privacy, supported where appropriate by family or staff. If it is not possible for the parents to hold their child, a member of staff should cuddle the baby until death is certified. The emotional support of the parents and family through this experience should be seen as a major responsibility of the intensive care staff. It is essential that sufficient numbers of experienced staff are available to meet the needs of the baby and the family both during and after the dying process. Photographs of the baby should be taken and copies preserved by the staff as a permanent record. Parents should be encouraged to name their child if this has not already occurred, and to make arrangements for a private funeral. Support should continue in the community once the parents leave hospital, and contact may be made with parent-support groups, for example, in the UK, SANDS (Society for Neonatal Deaths and Stillbirths). The results of any post-mortem examination should be communicated to the parents without delay. A medical follow-up appointment should be made with the senior paediatrician at 4–6 weeks after death. This allows discussion of the medical diagnosis and problems of the baby, the reasons for brain injury, and the events occurring around death. Emotional and social issues can be discussed and concerns about any future pregnancies can also be raised. Occasionally an infant will not die immediately, despite withdrawal of intensive support. In this eventuality it is important that ongoing palliative care is provided. This includes the provision of warmth and ‘tender loving care’ from parents and staff. Where appropriate hydration and feeding may be provided by infusion of milk via a nasogastric tube. Regular analgesia should be administered if there is any possibility that the infant may be in pain. If the child is likely to survive for more than a few days, it may be appropriate to suggest that the parents take the infant home to provide palliative care within the context of the family. Most parents can be taught to administer feeds via nasogastric tube and the care of the infant whose life expectancy is very limited seems much more appropriately situated in the family and the community rather than in hospital. Maximum support from community nursing services and the general practitioner is essential and their full co-operation must be ensured before discharge is contemplated. A night nursing service may be required to provide care at home during the night to allow the parents to sleep. Regular contact from the intensive care staff should be maintained while the child is at home, and readmission to hospital must be
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made available at the parents’ request. It is most important that parents who take a dying baby home should feel adequately supported by professionals. SUPPORT OF HOSPITAL STAFF It is important to recognize the degree of emotional stress experienced by medical and nursing staff who are involved in the withdrawal of support from a baby who has undergone intensive care (McHaffie and Fowlie, 1996). This is particularly true when care has been provided for weeks or months prior to death, and a close relationship has been established between the parents, the staff and the child. These tragic situations place extreme emotional and personal demands on hospital staff and their needs for emotional support and a chance to express their feelings are frequently unrecognized. It is common for staff to experience intense feelings of guilt, frustration and grief in these circumstances. Time and opportunity should be provided for the staff to express their feelings in private, and the pastoral care team should be involved where appropriate. The neonatal team needs to provide training for all its members in the withdrawal of life-support and the practical and psychological support of grieving parents. The team needs to foster a practice of open communication and a special responsibility rests on the consultant to communicate sensitively and support the more junior members of the team (McHaffie and Fowlie, 1996). It is important for senior staff to communicate that the skilful provision of terminal care, to ensure that a baby ‘dies well’ in the loving arms of his parents, may be as much a successful outcome of neonatal intensive care as ensuring the survival of an extremely sick infant. CONCLUSION Life-sustaining treatment may be ethically withdrawn or withheld in critically ill or dying newborns if the action is genuinely in the best interests of the patient. This may occur if life-sustaining treatment is futile because of a hopeless prognosis, or if the burdens of intensive treatment clearly outweigh its likely benefits. There is no fundamental ethical difference between the withholding of resuscitation and the withdrawing of life-sustaining treatment once it has commenced, and some parents may find it reassuring for treatment to be commenced and subsequently withdrawn when it is apparent that the outcome is hopeless. A decision to withdraw treatment should only be taken with the consensus of experienced staff caring for the baby and with the unpressurized agreement of the parents. Palliative care and symptomatic relief should continue after life-support has been withdrawn. Emotional and practical support should be provided for parents and adequate training and support is essential for neonatal unit staff. REFERENCES Chiswick M (1991) Ethical considerations of starting and stopping life support in newborn babies. Paediatrics in Europe 1.91: 17–19. Glover J (1977) Causing Death and Saving Lives. Harmondsworth, UK: Penguin Books. Higginson R (1987) Life, death and the handicapped newborn: a review of the ethical issues. Ethics & Medicine 3: 45–48. Kuhse H & Singer P (1985) Should the Baby Live? Oxford: Oxford University Press.
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McHaffie HE & Fowlie PW (1996) Life, Death and Decisions: Doctors and Nurses Reflect on Neonatal Practice. Cheshire, UK: Hochland & Hochland. Ramsay P (1978) Ethics at the Edges of Life. New Haven, London: Yale University Press. RCPCH (Royal College of Paediatrics and Child Health) (1997) Withholding or Withdrawing Life Saving Treatment in Children. London: Royal College of Paediatrics and Child Health. Singer P (1995) Rethinking Life and Death. Oxford: Oxford University Press. Whitelaw A (1986) Death as an option in neonatal intensive care. Lancet ii: 328–331.
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Baillière’s Clinical Obstetrics and Gynaecology Vol. 13, No. 4, p 513, 1999
B A I L L I È R E ’ S
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PRACTICE & RESEARCH
Part I: Conclusions The intrinsic ethical dimension of clinical decisions is already obvious when we consider the care of the fetus. For instance, Chervenak finds viability to be the point where the equilibrium between the interests or rights of the future person and the mother-to-be definitely changes. This explains his position that sex selection for social reasons is the choice of the mother, whereas Friend considers such an attitude with a more balanced view. It seems to be acceptable to perform embryo reduction in cases of multiple pregnancy of high order. This implies, however, that one takes into account the interests of a non-viable fetus, whilst at the same time disregarding the interests of one or more contemporary fetus(es). Similarly, Jones considers that it is legitimate to perform embryo research, as it is legitimate to use present embryos in order to give a better chance to future embryos. The problem is yet different when delivery is the only phenomenon that separates the potentiality for life and life in its legal sense. Both Friend and Wyatt have a very compassionate attitude. Friend considers the practitioner to be an advocate for the patient, whose autonomy has to be respected, after due counselling. Understandably, Wyatt considers his duty to be to take more of the responsibility of the decision, since the paediatrician must be an advocate for the baby as well as for the family as a whole. Furthermore, those considerations about clinical aspects have to be analysed in the context of society as a whole, with its rules, its economic constraints, its cultural influences. For example, it must be acknowledged that some recommendations, such as the presence of a chaperon during gynaecological examination are rather specific to Anglo-Saxon culture and would be difficult to accept in Latin countries. Similarly, the use of written consent forms is also, at least up to now, not universally required. Another example of a still-debated issue is the medical and societal attitude towards the refusal of caesarean section or the imprisonment for so-called ‘irresponsible behaviour’ of a future mother. As far as the latter is concerned, there are many countries where such a decision would be considered to be a violation of human rights, since it favours the interests of a not-yet-born, who by definition has no legal rights. Somewhat paradoxically, in the same countries a ‘forced caesarean section’ could be decided by the medical team, once the vital interests of the baby-to-be are clearly shown to be at stake. Both attitudes, i.e. acceptance of the principle of irresponsible behaviour and its judiciary consequences, and refusal of forced caesarean section, or its opposite, clearly show how difficult is the choice between the interests of the mother and those of the fetus, or, to put it another way, to decide when the rights of the new individual begin, from both the legal and the ethical point of view. Some considerations regarding these points will be examined in Part II. C. Sureau F. Kohane-Shenfield 1521–6934/99/040513 + 01 $12.00/00
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Neonatal care: withholding or withdrawal of treatment in the newborn infant John S. Wyatt
FRCP, FRCPCH
Professor of Neonatal Paediatrics University College London, 5 University Street, London WC1E 6JJ, UK
Life-sustaining treatment may be ethically withdrawn or withheld in critically ill or dying newborns if the action is genuinely in the best interests of the patient. This may occur in situations where life-sustaining treatment is futile because of a hopeless prognosis, or if the burdens of intensive treatment clearly outweigh its likely benefits. There is no fundamental ethical difference between the withholding of resuscitation and the withdrawing of life-sustaining treatment once it has commenced. However the actions may have different emotional and psychological implications. A decision to withdraw treatment should only be taken with the consensus of experienced staff caring for the baby and with the unpressurized agreement of the parents. Palliative care and symptomatic relief should always continue after life-support has been withdrawn. Emotional and practical support should be provided for parents and adequate training and support is essential for obstetric and neonatal unit staff. Key words: newborn human infant; selective withdrawal of treatment; extreme prematurity.
The remarkable development of neonatal intensive care over the last 20 years has led to acute clinical and ethical dilemmas for paediatricians, obstetricians and parents alike. The survival of extremely preterm infants born at less than 26 weeks gestation and weighing less than 750 g is now commonplace. A wide range of techniques to prolong life are now available for many infants with severe and previously untreatable congenital malformations. These technological advances have led to complex dilemmas for medical staff and parents. Should an attempt be made to resuscitate all premature babies however immature or severely malformed? Once intensive care has commenced, is it ethical to withdraw treatment in a baby whose prognosis is extremely poor? To what extent should the wishes of parents influence clinical decision-making in this complex and difficult area? In this chapter I shall aim to address these issues from the perspective of a practising neonatologist. ACTING IN THE PATIENT’S BEST INTERESTS The mainstream tradition of Western medical ethics, which is derived ultimately from Hippocratic sources, enshrines a fundamental orientation towards the protection and preservation of life, combined with a duty to protect the individual from harm. A recent report of the Royal College of Paediatrics and Child Health on the withdrawal of life saving treatment (RCPCH, 1997) defined the primary intention of the Health 1521–6934/99/040503 + 09 $12.00/00
© 1999 Harcourt Publishers Ltd.
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J. S. Wyatt
Care Team as ‘sustaining life and restoring their patients to health’. Yet the existence of sophisticated life-support technology means that it is possible to sustain life in circumstances where medical treatment seems to bring little or no benefit to the individual patient. In addition, invasive and intensive treatment can cause great suffering to the child, emotional trauma to the parents and family, and it can lead to the expenditure and diversion of scarce health resources for little obvious purpose. Although resource issues cannot be ignored, they must not be allowed to dominate the discussion. Central to all decisions about the appropriateness of life-sustaining treatment must be the ethical duty of care of the clinician and child health team; that is to act in the best interests of the individual child. Within this ethical framework, it is possible to conceive of a number of situations in which life-sustaining treatment should be withheld or withdrawn. The recent report of the Royal College of Paediatrics and Child Health (RCPCH, 1997) has suggested a number of scenarios in which treatment might be withdrawn from children and newborns, summarized under the following headings: the brain-dead child, the permanent vegetative state, the ‘no chance’ situation, the ‘no purpose’ situation, the ‘unbearable’ situation. In neonatal practice, I wish to suggest that these situations can be summarized under two headings: first, clinical conditions in which treatment is futile, and second, situations in which invasive medical treatment is excessively burdensome, relative to its possible benefits. WHEN LIFE-SUSTAINING TREATMENT IS FUTILE In the context of neonatal care, intensive care treatment can be regarded as futile if there is no possibility of long-term survival, as with an extremely preterm infant with an accurate gestational age of less than 22 weeks, or in the presence of a proven lethal malformation such as Trisomy 18 or anencephaly. In such cases it seems appropriate to withhold all intensive life-sustaining treatment and to provide palliative care and symptomatic treatment with the expectation that death will follow. Similarly, if a baby who is undergoing intensive care deteriorates irreversibly so that they are in the process of dying despite maximal treatment, then it is ethically appropriate to withdraw life-sustaining treatment in the recognition that death is inevitable. There is no ethical duty on physicians to provide medical treatment which has no possibility of success, nor is there a duty to prolong the process of dying. WHEN LIFE-SUSTAINING TREATMENT IS EXCESSIVELY BURDENSOME If the physician has a duty of care to act in the patient’s best interests, then it is essential that the benefits and burdens of each form of treatment be assessed to ensure that the expected benefits outweigh the burdens. There is no ethical duty on physicians to provide treatment whose burdens outweigh the possible benefits. Indeed the commencement or maintenance of treatment that can bring no benefit to the patient, may be viewed as a form of assault or abuse, and is clearly contrary to good ethical practice. From this perspective neonatologists must be prepared to withhold or withdraw intensive support in babies in whom the burdens of treatment outweigh the likely benefits. How might these concepts be translated into clinical practice? In the extremely preterm infant born in good condition at 24 or 25 weeks of gestation with
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an apparently normal brain, the burdens of several months of intensive care treatment are likely to be outweighed by the long-term benefits of the treatment. Conversely, in the infant born at an identical gestational age who is in very poor condition, with bilateral parenchymal cerebral haemorrhages or widespread periventricular leukomalacia, the potential benefits that prolonged intensive care may bring are dramatically reduced, and hence the withholding of intensive treatment may be appropriate. Similarly, the curative potential of intensive care in an infant with respiratory failure together with a profound congenital malformation such as thoraco-lumbar spina bifida and hydrocephalus, is likely to be considerably reduced compared with a child who has respiratory failure but no underlying malformation. The burdens of treatment may be similar in both cases but the potential benefits are significantly reduced in the first case. As a result it may be appropriate to withhold prolonged intensive care for the child with very severe fetal malformations because of the reduced benefits that such care can bring. Clearly the balancing of burdens and benefits will depend on the individual clinical circumstances and will necessarily involve a degree of subjectivity. As a result it is essential that these difficult decisions are discussed with clinical colleagues and with parents, so that wherever possible a consensus may emerge. If life-sustaining treatment is withheld in cases where major congenital malformations are present, it should be clear that this is genuinely in the patient’s best interests, that is that the burdens of treatment are clearly excessive, rather than due to a covert prejudice that the lives of disabled people are somehow of less value to themselves or to society. It has been frequently suggested, both by ethicists and by clinicians, that some kind of ‘quality of life’ criteria should be used to decide whether the continuation of intensive care is worthwhile (Kuhse and Singer, 1985; Whitelaw, 1986; Chiswick, 1991). Some ethicists have gone further and argued that certain lives have a negative value; in other words that death is always preferable to certain forms of living in a disabled state (Glover, 1977; Kuhse and Singer, 1985; Singer, 1995). But it is not at all obvious on what basis these value judgements are made and other ethicists have challenged this concept. Paul Ramsey, for example, argues that it is not appropriate for us as mere human beings to judge the quality of other people’s lives, and in any case we are quite incapable of doing it adequately (Ramsey, 1978). Richard Higginson also argues that it is inappropriate to allow doctors to use ‘quality of life criteria’ in making decisions about life-sustaining treatment (Higginson, 1987). Higginson states that he is prepared to trust a doctor’s competence in medical judgements such as the distinction between when a patient is living or dying. However ‘. . . where neither he [Ramsey] or I are prepared to trust a doctor’s competence is when they presume to judge whether a person’s life is worth living’ (Higginson, 1987). This criticism has force and it highlights the pitfalls inherent in the medical judgement of the quality of life. As Higginson argues, it is not obvious that doctors have any special expertise that allows them to presume to judge the ultimate value or significance of another human life. I wish to argue that within the context of traditional medical ethics, the doctor’s role is to assess and balance the relative value of different treatment options, rather than to assess the relative value of an individual’s life compared with other lives. In my view, the doctor may determine whether a treatment is futile or valueless, but the doctor can never determine whether an individual life is futile or valueless. Like Ramsey and Higginson, I do not believe that doctors are better equipped than anyone else to decide the ultimate value of another person’s life. Where they do have special expertise is in the balancing of the burdens and benefits of different forms of medical intervention.
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THE INFANT WITH SEVERE BRAIN INJURY One of the most difficult decisions facing the practising neonatologist is whether lifesustaining treatment should be withdrawn from the infant undergoing intensive care who has evidence of severe and irreversible brain injury. What criteria should be used to guide clinical decisions in this situation? The traditional diagnoses of brain-stem death and the permanent vegetative state cannot be reliably determined in the newborn, and these diagnostic categories should not be employed. Before withdrawal of support can be contemplated it is important to obtain as much objective information about anatomical damage and functional impairment of the central nervous system as possible. This may include a structured neurological examination, cranial ultrasound scanning, neurophysiological measurements and, where possible, computerized tomography (CT) or magnetic resonance (MR) imaging of the brain. The prognosis for neurodevelopmental outcome should be discussed in detail with the parents, recognizing that even when detailed information about the brain is obtained, there is always a degree of uncertainty in the long-term prognosis. This information can then be used to weigh against the burdens of prolonged intensive care and other medical treatments that may be required in the future. In my view the most critical capacity for assessing the likely benefits of treatment is that for loving and interactive human relationships. Brain injury that causes impaired mobility or loss of visual or auditory function, whilst capacity for loving relationships is retained, is very different from injury of such severity that no relationships are possible. Whilst the presence of such brain injury would not prevent the infant from being regarded with respect and dignity, it does raise questions about the appropriateness of prolonging survival by intensive medical and technological support. In such cases the burdens of intensive care can be seen to outweigh the benefits. If such an outcome can be predicted with reasonable certainty, it is, in my view, ethically justifiable to withdraw support with the realization that the infant will almost certainly die as a result. In practice, these criteria would imply brain injury of sufficient severity to cause global destruction of cortical and subcortical structures in both cerebral hemispheres. This degree of brain destruction may occur in severe bilateral intraparenchymal haemorrhagic infarction, severe cystic periventricular leukomalacia, or severe hypoxicischaemic encephalopathy. Even with the benefits of extensive investigation, the prediction of long-term neurodevelopmental outcome in the extremely preterm infant is by no means an exact science. The variable response of the immature nervous system to injury and the potential plasticity of neural connections contribute to the unpredictability of longterm outcome. Where there is a substantial degree of uncertainty in the prognosis, it is appropriate to continue intensive support, whilst carrying out regular assessment of the baby’s condition, in the hope that the likely outcome will become clearer. IS THERE A DIFFERENCE BETWEEN THE WITHHOLDING OF INTENSIVE TREATMENT AND THE WITHDRAWING OF TREATMENT THAT HAS BEEN COMMENCED? Clinicians and parents frequently perceive a major difference between the withholding of resuscitation in a critically ill baby at birth, and the withdrawal of life-sustaining treatment after intensive care has commenced and the baby has been transferred to
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an intensive care unit. Neonatologists may feel that it is psychologically much harder to stop treatment after it has been commenced and as a result they may fear that intensive care may be continued in an inappropriate manner. From a medico-legal perspective, clinicians may be concerned that the cessation of intensive care treatment may be regarded as tantamount to intentional killing by legal authorities, and opens them to the risk of criminal charges. Obstetricians may feel that the commencement of resuscitation implies an irreversible and irrational commitment to sustain life whatever the consequences and may worry that the parents are being offered false hope that intensive care can save their child. From an ethical perspective the withholding and the withdrawing of life-sustaining treatment seem to be equivalent. In both cases the intention is to prevent treatment and in both cases the outcome is the same. However from my own experience, there may be psychological benefits from commencing intensive care, even when the chances of long-term survival are slight. Parents who are confronted with the delivery of an extremely preterm baby are frequently concerned that ‘everything possible is done’. If a decision is made not to commence resuscitation, parents may be left with a longlasting anxiety that their child might have survived in other circumstances. A short period of intensive care will reassure the parents that the child has been given the best possible chance of survival, and may allay fears that the baby might have survived ‘if only the doctors had tried harder’. In addition, commencement of life-sustaining treatment and admission to a neonatal intensive care unit may enable a brief time for the parents (and possibly other relatives such as siblings and grandparents) to meet their child. It allows time for baptism, or some other religious ceremony if this is the parents’ wish. It also enables palliative treatment with analgesia and sedatives to be given to prevent any possibility of suffering, and appropriate emotional support given to the parents and other relatives by the neonatal unit staff. If, after a brief period of intensive care, it is obvious that the outlook is hopeless, further discussion with parents should be undertaken and, with their agreement, mechanical ventilation and other therapies can be withdrawn in controlled circumstances. The family should be encouraged to cuddle and grieve for their infant in a private room, with the support of the staff. Despite the pain and grief, many parents gain consolation and comfort from this experience, knowing that everything possible was done for their child. Against these possible benefits must be weighed the appropriateness of using scarce and expensive intensive care resources if the outlook is hopeless. I would argue that the emotional benefit for the parents of meeting their child does justify the use of intensive care resources in these limited circumstances. The capacity for the extremely preterm infant to feel pain remains unclear, but the appropriate use of opiates and sedatives can safeguard against the possibility of suffering. Another argument in favour of commencing intensive care in infants of questionable viability is the possibility of error in the calculation of gestational age. Small variations in gestational age may lead to large differences in the chances of survival. Thus at 22 weeks gestation the chances of survival are virtually nil, whereas 2 weeks later, at 24 weeks, the chances of survival are currently over 50% in many major centres. Gestational age assessment before and after birth is frequently unreliable, particularly where an early antenatal ultrasound scan has not been performed. In such cases it may be appropriate for an experienced paediatrician to assess the baby immediately after birth and to commence intensive care if it seems possible that the baby is more mature than had been anticipated. In effect the baby is given ‘the benefit of the doubt’. After resuscitation the baby should be transferred to a neonatal intensive care unit and thoroughly assessed with particular attention to the lungs, circulation and central
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nervous system, including cranial ultrasound examination. If it becomes apparent that the outlook is hopeless, intensive care can then be stopped after full explanation and discussion with the parents. In general it seems far better to make these critical decisions under controlled circumstances in the intensive care unit rather than in the heat of the moment in the labour ward. If the availability of neonatal intensive care resources is seriously limited, it may not be appropriate to ‘block’ a space in the intensive care unit with a very immature infant who has only a poor chance of survival. This might well lead to the death or injury of more mature infants who are delivered subsequently. Under these circumstances it may be appropriate to withhold resuscitation and intensive care from infants of less than 25 weeks gestation or <750 g birthweight in the expectation that they would die shortly after birth. Obviously it is vital that basic palliative nursing care should be provided to all infants even if intensive support techniques are withheld. (This policy does however raise the remote possibility that an extremely preterm infant might survive despite the withholding of intensive care, but with a greater degree of brain injury.) WHO SHOULD BE INVOLVED IN A DECISION TO WITHDRAW LIFE-SUSTAINING TREATMENT? By far the commonest reason for withdrawing intensive support is the recognition that the infant is dying and that the continuation of intensive care is merely prolonging the process of dying. This stage is usually obvious due to the presence of profound respiratory failure, bradycardia and hypotension despite maximal cardiorespiratory support. The decision to withdraw care may have to be taken as an emergency, and there may be little time to consult with colleagues or with the parents. Unless there is a clear reason for prolonging the phase of dying in order to allow the parents to spend time with the child, there should be a rapid withdrawal of intensive support. Performing prolonged resuscitative efforts in this situation should be avoided at all costs, and wherever possible the baby should be allowed to die in the parents’ arms rather than connected to the panoply of intensive care machinery. Where the withdrawal of intensive care is contemplated despite the fact that the acute condition of the infant is stable, more time is available for detailed discussion. Because of the momentous implications of withdrawing intensive support from such an infant, appropriate safeguards are essential. There should be unequivocal agreement amongst the senior medical and nursing staff involved that global, devastating and irreversible brain injury has occurred, and that the outlook is hopeless. Where possible a ‘second opinion’ from an independent paediatric or neurological consultant should be sought. In the event of major uncertainty about the extent or severity of brain injury, full intensive support should continue. On both ethical and medico-legal grounds the senior clinician carries ultimate responsibility for all medical treatment that is carried out. However, the parents of the child are clearly intimately involved and detailed explanation and discussion with them is essential. Time must be given for the parents to discuss the issues fully and their full and unpressurized agreement to the course of action is essential. Where appropriate, counselling staff, or the hospital pastoral care team, should be involved. If the parents cannot agree to the withdrawal of life-sustaining treatment, intensive care should continue. Further time for unpressurized discussion and explanation with the parents should be given. Ultimately it may be necessary to recourse to the Courts for permission to cease treatment against
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the wishes of the parents, but this is likely to be a lengthy and distressing process, and is rarely necessary in practice. In British clinical practice, resort to an independent ethical committee with executive power to prescribe forms of clinical management does not seem to be a satisfactory way of resolving these difficult ethical decisions in neonatal intensive care (Whitelaw, 1986). PRACTICAL MANAGEMENT OF THE WITHDRAWAL OF INTENSIVE SUPPORT Withdrawal of life-sustaining treatment should take place in an unhurried, private and dignified manner. It may be appropriate to administer an adequate dose of opiate analgesia together with a sedative, such as a benzodiazepine, to avoid any possibility of suffering. The parents should be given time to be alone with their child and suitable facilities for baptism or other religious ceremonies should be provided. When it is appropriate, the infant should be disconnected from the ventilator and other intensive care equipment and should be clothed and wrapped in a shawl or blanket. A private room should be provided to allow the parents to hold their child and express their grief in privacy, supported where appropriate by family or staff. If it is not possible for the parents to hold their child, a member of staff should cuddle the baby until death is certified. The emotional support of the parents and family through this experience should be seen as a major responsibility of the intensive care staff. It is essential that sufficient numbers of experienced staff are available to meet the needs of the baby and the family both during and after the dying process. Photographs of the baby should be taken and copies preserved by the staff as a permanent record. Parents should be encouraged to name their child if this has not already occurred, and to make arrangements for a private funeral. Support should continue in the community once the parents leave hospital, and contact may be made with parent-support groups, for example, in the UK, SANDS (Society for Neonatal Deaths and Stillbirths). The results of any post-mortem examination should be communicated to the parents without delay. A medical follow-up appointment should be made with the senior paediatrician at 4–6 weeks after death. This allows discussion of the medical diagnosis and problems of the baby, the reasons for brain injury, and the events occurring around death. Emotional and social issues can be discussed and concerns about any future pregnancies can also be raised. Occasionally an infant will not die immediately, despite withdrawal of intensive support. In this eventuality it is important that ongoing palliative care is provided. This includes the provision of warmth and ‘tender loving care’ from parents and staff. Where appropriate hydration and feeding may be provided by infusion of milk via a nasogastric tube. Regular analgesia should be administered if there is any possibility that the infant may be in pain. If the child is likely to survive for more than a few days, it may be appropriate to suggest that the parents take the infant home to provide palliative care within the context of the family. Most parents can be taught to administer feeds via nasogastric tube and the care of the infant whose life expectancy is very limited seems much more appropriately situated in the family and the community rather than in hospital. Maximum support from community nursing services and the general practitioner is essential and their full co-operation must be ensured before discharge is contemplated. A night nursing service may be required to provide care at home during the night to allow the parents to sleep. Regular contact from the intensive care staff should be maintained while the child is at home, and readmission to hospital must be
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made available at the parents’ request. It is most important that parents who take a dying baby home should feel adequately supported by professionals. SUPPORT OF HOSPITAL STAFF It is important to recognize the degree of emotional stress experienced by medical and nursing staff who are involved in the withdrawal of support from a baby who has undergone intensive care (McHaffie and Fowlie, 1996). This is particularly true when care has been provided for weeks or months prior to death, and a close relationship has been established between the parents, the staff and the child. These tragic situations place extreme emotional and personal demands on hospital staff and their needs for emotional support and a chance to express their feelings are frequently unrecognized. It is common for staff to experience intense feelings of guilt, frustration and grief in these circumstances. Time and opportunity should be provided for the staff to express their feelings in private, and the pastoral care team should be involved where appropriate. The neonatal team needs to provide training for all its members in the withdrawal of life-support and the practical and psychological support of grieving parents. The team needs to foster a practice of open communication and a special responsibility rests on the consultant to communicate sensitively and support the more junior members of the team (McHaffie and Fowlie, 1996). It is important for senior staff to communicate that the skilful provision of terminal care, to ensure that a baby ‘dies well’ in the loving arms of his parents, may be as much a successful outcome of neonatal intensive care as ensuring the survival of an extremely sick infant. CONCLUSION Life-sustaining treatment may be ethically withdrawn or withheld in critically ill or dying newborns if the action is genuinely in the best interests of the patient. This may occur if life-sustaining treatment is futile because of a hopeless prognosis, or if the burdens of intensive treatment clearly outweigh its likely benefits. There is no fundamental ethical difference between the withholding of resuscitation and the withdrawing of life-sustaining treatment once it has commenced, and some parents may find it reassuring for treatment to be commenced and subsequently withdrawn when it is apparent that the outcome is hopeless. A decision to withdraw treatment should only be taken with the consensus of experienced staff caring for the baby and with the unpressurized agreement of the parents. Palliative care and symptomatic relief should continue after life-support has been withdrawn. Emotional and practical support should be provided for parents and adequate training and support is essential for neonatal unit staff. REFERENCES Chiswick M (1991) Ethical considerations of starting and stopping life support in newborn babies. Paediatrics in Europe 1.91: 17–19. Glover J (1977) Causing Death and Saving Lives. Harmondsworth, UK: Penguin Books. Higginson R (1987) Life, death and the handicapped newborn: a review of the ethical issues. Ethics & Medicine 3: 45–48. Kuhse H & Singer P (1985) Should the Baby Live? Oxford: Oxford University Press.
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McHaffie HE & Fowlie PW (1996) Life, Death and Decisions: Doctors and Nurses Reflect on Neonatal Practice. Cheshire, UK: Hochland & Hochland. Ramsay P (1978) Ethics at the Edges of Life. New Haven, London: Yale University Press. RCPCH (Royal College of Paediatrics and Child Health) (1997) Withholding or Withdrawing Life Saving Treatment in Children. London: Royal College of Paediatrics and Child Health. Singer P (1995) Rethinking Life and Death. Oxford: Oxford University Press. Whitelaw A (1986) Death as an option in neonatal intensive care. Lancet ii: 328–331.
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Baillière’s Clinical Obstetrics and Gynaecology Vol. 13, No. 4, p 513, 1999
B A I L L I È R E ’ S
BEST
PRACTICE & RESEARCH
Part I: Conclusions The intrinsic ethical dimension of clinical decisions is already obvious when we consider the care of the fetus. For instance, Chervenak finds viability to be the point where the equilibrium between the interests or rights of the future person and the mother-to-be definitely changes. This explains his position that sex selection for social reasons is the choice of the mother, whereas Friend considers such an attitude with a more balanced view. It seems to be acceptable to perform embryo reduction in cases of multiple pregnancy of high order. This implies, however, that one takes into account the interests of a non-viable fetus, whilst at the same time disregarding the interests of one or more contemporary fetus(es). Similarly, Jones considers that it is legitimate to perform embryo research, as it is legitimate to use present embryos in order to give a better chance to future embryos. The problem is yet different when delivery is the only phenomenon that separates the potentiality for life and life in its legal sense. Both Friend and Wyatt have a very compassionate attitude. Friend considers the practitioner to be an advocate for the patient, whose autonomy has to be respected, after due counselling. Understandably, Wyatt considers his duty to be to take more of the responsibility of the decision, since the paediatrician must be an advocate for the baby as well as for the family as a whole. Furthermore, those considerations about clinical aspects have to be analysed in the context of society as a whole, with its rules, its economic constraints, its cultural influences. For example, it must be acknowledged that some recommendations, such as the presence of a chaperon during gynaecological examination are rather specific to Anglo-Saxon culture and would be difficult to accept in Latin countries. Similarly, the use of written consent forms is also, at least up to now, not universally required. Another example of a still-debated issue is the medical and societal attitude towards the refusal of caesarean section or the imprisonment for so-called ‘irresponsible behaviour’ of a future mother. As far as the latter is concerned, there are many countries where such a decision would be considered to be a violation of human rights, since it favours the interests of a not-yet-born, who by definition has no legal rights. Somewhat paradoxically, in the same countries a ‘forced caesarean section’ could be decided by the medical team, once the vital interests of the baby-to-be are clearly shown to be at stake. Both attitudes, i.e. acceptance of the principle of irresponsible behaviour and its judiciary consequences, and refusal of forced caesarean section, or its opposite, clearly show how difficult is the choice between the interests of the mother and those of the fetus, or, to put it another way, to decide when the rights of the new individual begin, from both the legal and the ethical point of view. Some considerations regarding these points will be examined in Part II. C. Sureau F. Kohane-Shenfield 1521–6934/99/040513 + 01 $12.00/00
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