Critical care decisions in fetal and neonatal medicine: ethical issues
The clinical context
3.5 An understanding of what fetal and neonatal medicine can and cannot achieve is crucial to addressing the difficult choices that families, professionals and policy makers may have to make. The medical advances that have prompted the dilemmas discussed in this Report have occurred in three main areas. First, in fetal medicine there have been major improvements in the diagnosis of fetal abnormalities and illness. A great deal can now be discovered about the health of the fetus through the use of new technologies. Secondly, some babies born at low gestational ages respond to resuscitation and can be helped to survive. Thirdly, much more is known and continuing to be discovered about what causes babies to suffer pain or develop disabilities. Doctors are therefore better placed to make predictions about how a baby may be affected by a particular disability later in life, although usually it will be difficult to give parents precise information when asking for their consent to any treatment (see Appendix 5).
3.6 One feature common to these developments in fetal and neonatal medicine is that the improved ability to diagnose problems is not yet matched by the prospect of effective treatment with medicine or surgery. Another is the uncertainty of the initial prognosis for a particular baby. We shall see that in some cases doctors can give parents a reasonably certain account of whether their child is likely to survive, for how long and if he or she will have any disabilities. In many others, however, doctors may have to base their advice on statistical probabilities derived from studies such as EPICure (see paragraphs 5.7–5.11) and will be unable to tell parents how their baby will fare, nor predict the extent of any disability that he or she may develop.
The impact of antenatal screening on neonatal survival and disability
3.7 While routine antenatal screening is accepted by the majority of pregnant women and provides reassurance for many, it may also give the first indication that the health of a fetus or the future baby may be compromised. Screening is a public health service through which members of a defined population are offered a test. The purpose is to identify individuals who are more likely to be helped than harmed by further tests or treatment to reduce the risk of a disease or its complications.13 Improved antenatal diagnosis of problems with fetal health has provided new challenges for pregnant women, their families, health professionals and for society as a whole. Routine screening has meant that more pregnant women now experience moral dilemmas because of the diagnosis of fetal problems which would, in the past, have been apparent only after birth.14 In the UK, the numbers of fetal abnormalities identified by the screening processes are not systematically recorded. Most are not life threatening and are dealt with after birth. The options for fetal surgery or treatment in the womb
are still very limited, so when a fetus is in poor condition, the choice is often between continuing a pregnancy in the knowledge of an increased risk of the fetus or baby dying or having childhood disability, delivering the baby early or terminating the pregnancy (paragraph 4.2). A baby may be delivered early if problems have been identified. A decision is made after considering the risks for the woman and for the fetus. The immediate risks for the woman are generally resolved by delivery. When a fetus is at risk, the crucial question is whether the delivery of an extremely premature baby with consequent risks to the baby’s health is justified by the seriousness of the problems (see paragraphs 4.3–4.6). Doctors have had to balance the risks of premature birth against continuation of a pregnancy since neonatal intensive care practices were first developed in the 1960s. Consequently data on outcomes are available to inform current practice (see paragraphs 5.7–5.11 and Table5.1). Parents confronted with difficult decisions may find non-directive counselling15 helpful when facilities in National Health Service (NHS) units are available. They can also seek advice from patient support groups such as Antenatal Results and Choices (ARC).16
The borderline of viability
3.8 Birth at the borderline of viability (up to and including 25 weeks and six days of gestation) usually occurs through natural causes. More rarely, it can result from clinical intervention (see paragraph 3.7). Approximately 0.3% of all deliveries (including both live and stillbirths) in England (1,620 in 2004–5)17occur at the borderline of viability. For babies born alive at these gestational ages, the prospects for survival are generally much less than 50% and if a baby survives, he or she is at risk of some level of disability, although as we have said, predicting
the outcome for a particular baby at the time of birth is difficult (see Chapter 5). In such cases a widely used approach is for full neonatal intensive care to be instituted until the prognosis becomes clearer.18 This may be when the results of investigations are known or after a period when the clinical picture changes.
Neonatal resuscitation and intensive care
3.9 During the mid-1960s it became possible to save the life of a newborn baby who had stopped breathing by using mechanical ventilation. At the same time progressively more complex surgery was developed to correct life-threatening abnormalities in the newborn baby. Currently, approximately one in eight babies in the UK needs some level of special care after birth, and approximately one in 40 needs the highest level of intensive care.19 These babies need special care for a variety of reasons. They may have been born at the borderline of viability or at or near term. Most babies born before 32 weeks of gestation and/or those with a very low birthweight will need to spend at least some time in high-dependency care.20 National data on the reasons for which babies are admitted to neonatal units are not currently available.21 However, some insight can be gained from a report published by a neonatal intensive care unit (NICU) in the UK where babies born up to and including 32 weeks of gestation make up around a quarter of all the NICU admissions.22 Approximately one fifth of the intensive care cots in 2004–5 were occupied by babies born at 23–24 weeks of gestation, who stayed for an average of eight weeks.23 The remaining patients were babies born at or near term who were ill because of breathing problems, congenital abnormalities, infection, brain injury, feeding difficulties or jaundice.
3.10 We concluded in Chapter 2 that certain circumstances merit discussion of whether all possible means of preserving the life of a baby should be tried. Critical care dilemmas arise in several situations. For extremely premature babies born at the borderline of viability or other babies who are unable to breathe unassisted, whether premature or born at term, decisions might have to be made about whether to begin resuscitation (see Box3.2). When babies are dependent on artificial ventilation, the parents and doctors may have to decide whether to continue this and other interventions that constitute treatment (see Box3.2). For some babies, life-saving therapies will mean lifelong severe disabilities or only prolong inevitable death.24
For babies with brain injuries, information from scans may be sufficient for a prognosis on which to base a discussion with parents about the withdrawal of treatment and substitution with palliative care if further intensive treatment is believed to be futile. However, for babies born with serious lung or other injuries, it can be very difficult for doctors to predict the extent of the chronic illness from which they will suffer in the future (see paragraph 3.28), and consequently decisions to withdraw treatment in such cases are rare.
| Box 3.2: Medical procedures in neonatal medicine
Resuscitation Most babies require only gentle stabilisation after birth, allowing them to start breathing while ensuring that body temperature is maintained. However, very premature babies or babies born in a poor condition may need more invasive treatment to facilitate breathing. Resuscitation will be considered for a baby born at the limits of viability and any baby who does not start breathing unaided. The procedures below may be carried out. After birth, the baby is taken to a warm resuscitation platform or ‘resuscitaire’ and placed in a plastic bag to minimise evaporation and drying which make the baby cold. The baby’s lungs are inflated with air (and possibly additional oxygen) using a face mask connected to a bag which is rhythmically squeezed. If the heart rate is below 60 beats per minute, inflation of the lungs is combined with rhythmic compression of the chest to improve oxygen delivery to the heart muscle and thus assist the baby’s heart to pump. If he or she does not start breathing after a few breaths, or if chest inflation is ineffective using a face mask, a tube is inserted into the trachea (windpipe). Intubation is a skilled procedure carried out using a laryngoscope to visualise the trachea and the vocal cords, and may require several attempts. Once the baby has been successfully intubated, the tube is secured onto his or her face to deliver ventilation more effectively by hand or so that the tube can be connected to a mechanical ventilator. If the heart rate does not increase despite effective inflation of the lungs, chest compression is continued and adrenaline or other drugs are injected through a catheter inserted into the umbilical vein to speed up the pumping of the heart. This is also a skilled procedure that must be carried out using a sterile technique. In some cases, the baby does not achieve a normal heart rate of 120–160 beats per minute, a pink colour, spontaneous breathing or responsiveness after carrying out these procedures. The clinician may then decide to administer injections of salt water (saline), glucose or sodium bicarbonate depending on the results of analysis of blood samples. In some cases, a blood transfusion is urgently required. Very premature babies born at under 30 weeks of gestation usually have surfactant injected into their lungs, which facilitates lung expansion. After a baby has been resuscitated, a catheter is inserted at the earliest opportunity through the umbilical artery so that the tip lies in the aorta, the main artery of the body. Once the catheter is fixed in place it can be used to measure blood pressure, heart rate, and the composition of gases in the blood and pH levels without causing pain. Clinicians are able to use this information to guide their decisions on ventilation and further resuscitation as necessary. Although the procedures described above are very invasive and stressful for a baby, resuscitation saves lives.* Withdrawal of life support The most common situation where withdrawal of life support may be contemplated is when a baby is dependent on a respirator because his or her breathing has failed. Withdrawal of life support will involve removing the tube from the baby’s windpipe so the ventilator is no longer inflating the lungs. Many parents will want to hold their baby when this procedure is carried out. Morphine is frequently used to provide pain relief and sedation when a baby is ventilated and this would normally be continued after ceasing ventilation to relieve any distress from difficulty in breathing. Alternatively, a decision might be made to continue ventilation but to withdraw or withhold medication being used to support the heart and blood pressure. When this is done, the reduced circulation of blood results in the baby gradually becoming unconscious. Another decision might be to not give cardiac massage or an injection of adrenaline (to try and restart the heart) if a cardiac arrest occurs. In other situations, withdrawal of life support might take the form of a decision not to treat an infection, especially pneumonia, with antibiotics. The parents and doctors might also make a decision to withhold surgery for a life-threatening condition, such as a severe heart defect (see paragraph 6.12). In all of these examples, if the baby dies, the primary cause of death is the disease or abnormality. When life support is withdrawn, a dying baby will still receive other forms of treatment aimed at comfort and relief of symptoms, commonly termed ‘palliative care’ (see paragraphs 6.18–6.21). |
Clinical trials and neonatal care
3.11 The care of the newborn is often integrally linked with clinical research that seeks to develop, refine and assess the impact of new technologies and methods of treatment. We recognise that clinical trials are important to identify the best forms of clinical care for these babies and to ensure that the benefits outweigh the risks of adverse effects. A description of how trials are conducted is provided in Appendix 6.
13 Defined by the UK National Screening Committee.
14 Williams C, Sandall J, Lewando-Hundt G etal. (2005) Women as moral pioneers? Experiences of first trimester antenatal screening Soc Sci Med61: 1983–92.
15 Nuffield Council on Bioethics (1998) Mental Disorders and Genetics:The ethical context(London: NCOB), paragraphs 8.31–8.38.
16 See the Antenatal Results and Choices website, available at: http://www.arc-uk.org.
17 National Statistics (2006) NHS Maternity Statistics, England: 2004–05, Table21. Data for the other countries in the UK are collected in a different way from those in England and so cannot be combined. Figures for England are included as an example. The EPICure study, however, covers the UK and the Republic of Ireland.
18 “The greater the immaturity, the more needs to be done to support a baby’s breathing (often with mechanical ventilation), and to protect them from infection and to achieve growth equivalent to that which occurs in the womb. Thus even ‘well’ very premature babies require intensive care simply to support their organ systems until they have matured. This includes sophisticated mechanical ventilation with oxygen, intravenous feeding, and the use of incubators to control body temperature and protect from infection. It also involves treatment of illnesses which are more common in such vulnerable babies. Several weeks of intensive care may be needed for babies born prematurely, as for babies who are ill or who have congenital disorders. After that, some babies may need further weeks of high dependency or special care provided in neonatal units. Neonatal intensive care is also required for a small number of larger, more mature, babies who become ill from complications of delivery, from infection or metabolic disorders or when surgical or other treatment is required for congenital abnormalities such as congenital heart disease, disorders of the lung or gut, or of other organs.” See Department of Health (2003) Report of the Neonatal Intensive Care Services Review Group, available at:
http://www.dh.gov.uk/assetRoot/04/01/87/44/04018744.pdf, accessed on: 15 June 2006.
19 BLISS–The premature baby charity (2005) Special Care for Sick Babies – Choice or chance?(London: BLISS), available at:
http://www.bliss.org.uk/pdfs/Special_care.pdf, accessed on: 27 June 2006. In the UK there are 230 hospitals that provided some form of neonatal care. Approximately 20% of the neonatal units in these hospitals can be defined as level 1 units, i.e. they provide special care but do not aim to provide any continuing high dependency or intensive care. Approximately 35% of the units can be defined as level 2 units, i.e. they provide high-dependency care and some short-term intensive care; while 45% were defined as level 3 units, i.e. they provide the full range of medical neonatal care. See Redshaw M and Hamilton K (2005) A Survey of Current Neonatal Unit Organisation and Policy(Oxford: National Perinatal Epidemiology Unit).
20 High-dependency care is a form of intensive care provided by level 2 and level 3 intensive care units and entails breathing support and intravenous nutrition, along with other care needs, depending on the individual baby. See Teamwork Management Services Limited (2005) Neonatal Medicine: Review of intensive and high dependency care for Greater Manchester, East Cheshire and High Peak Children and Young People’s Network – Final report(Bolton: Teamwork Management Services Limited).
21 However, the RCPCH and BAPM are coordinating the collection of a national dataset.
22 University of Bristol and North Bristol NHS Trust Southmead Hospital Neonatal Medicine Annual Report 2003, available at:
http://www.nbt.nhs.uk/services/wch/nicu/documents/Southmead%20NICU%20Annual%20Report%202003.pdf, accessed on: 27 June 2006; University of Bristol and North Bristol NHS Trust Southmead Hospital Neonatal Medicine Annual Report 2004, available at:
http://www.nbt.nhs.uk/services/wch/nicu/documents/Southmead%20NICU%20Annual%20Report%202004.pdf, accessed on: 27 June 2006.
23 Personal communication from Professor Andrew Whitelaw, consultant neonatologist, Bristol Southmead Hospital.
24 This type of case will sometimes reach the courts when parents and doctors have disagreed over the appropriateness of continuing treatment when no benefits are perceived by one of the parties (see Chapter 8).