Ethical Decisions in the Delivery Room

ETHICAL DILEMMAS IN THE PRENATAL, PERINATAL, AND NEONATAL PERIODS

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ETHICAL DECISIONS IN THE DELIVERY ROOM Jay P. Goldsmith, MD, Harley G. Ginsberg, MD, and Marie C. McGettigan, MD

Ethical analysis of difficult medical issues is not an arcane art limited only to certain "intensivist" physicians. Such analyses occur daily in pediatric practice in an attempt to do the "right thing." Generally, ethical decisions are relatively easy, even instinctive, protecting life and health over economic and psychosocial costs. Difficulties arise when outcomes are uncertain and treatment may be painful and expensive or cause prolongation of suffering. Issues become even more complex when neonates are involved. Newborns depend totally on parents, physicians, and government to protect their interests. They cannot be informed or make personal choices. Their personal values are those of their parents, tempered only by society. Cardiopulmonary resuscitation (CPR) in the delivery room (DR) is a therapeutic modality that presents clinicians with significant ethical issues. The resuscitation of critically ill infants is a difficult choice, one that initiates a cascade of events that usually results in admission to the neonatal intensive care unit: assisted ventilation, parental bonding, prolonged, often painful and expensive therapy, and frequently an imperfect outcome. The DR decision to not resuscitate must be made rapidly, always without the advice of a bioethics committee, usually without full knowledge of the baby's physical condition and future potential, and commonly without consultation with the family. This article attempts to give clinicians some insight into the decision-making process, identifying factors that bias the evaluation and supplying base-

From the Departments of Pediatrics and Neonatology, Ochsner Clinic and Alton Ochsner Medical Foundation, New Orleans, Louisiana

CLINICS IN PERINATOLOGY VOLUME 23 •NUMBER 3 •SEPTEMBER 1996

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line background data on outcomes, which may be used in reaching ethical decisions. Clinicians involved in difficult ethical decisions must be cognizant of their own personal and religious views on the meaning of life. Moreover, practicing physicians should be mindful of civil and even criminal liabilities (which differ according to locale) when making lifeterminating decisions. The undertaking of CPR in the DR for an extremely compromised neonate is made difficult by several factors. The first is the clinician's inability to make precise diagnoses unless such judgments are obvious. Resuscitation of a 350-g, 21-week fetus, or an anencephalic infant should not be initiated because prolonged survival is impossible, and such actions would be considered futile. But commencing CPR on a 500-g, 23- to 24-week-gestation neonate, or an infant with phenotypic abnormalities is more controversial. A second factor is the inability to make judgments on the presenting clinical condition of the baby. A stillborn infant with no audible heartbeat may have electrical activity of the heart and be viable with aggressive CPR. 23 A third factor is the unknown future potential of an infant. Will an extremely immature infant survive or die, develop severe intraventricular hemorrhage and become severely handicapped, or develop normally? Do statistics matter in this situation? Most physicians do not want to surrender their moral judgment on treatment decisions to arbitrary guidelines. Unless one is an advocate of vitalism (the belief that any life should be prolonged at all costs as long as technically possible), most physicians would agree that there are boundaries at both ends of the treatment spectrum. One boundary is that every patient meeting certain criteria in a particular category should be resuscitated even though the outcome may be suboptimal; the opposite boundary is that all patients in that category should not be resuscitated. A continuing problem in neonatology is that the boundaries constantly change. Today, most clinicians would resuscitate infants with spina bifida or premature infants weighing 500 to 750 g. Not very long ago these infants fell into the do not resuscitate (DNR) category. 41 Individual, religious, and legal views on the meaning and purpose of life cloud the issue of who should survive. Allocating treatment decisions (i.e., CPR) for critically ill newborns based on assumptions of future mental and physical development or social adaptability places decision makers on the "slippery slope," the bottom of which holds "no person or value sacred as against social utility." 36 Ethical judgments based on social utility may reflect economic, social, cultural, religious, or racial bias and easily may be abused. Given the limited resources society allocates to all medical care, economics must be considered when making ethical choices. The provision of heroic and expensive medical care to all infants with questionable future potential must be weighed against the opportunity cost of those health care dollars lost to other segments of medical care, especially for disadvantaged populations. (Please see the article by Meadow et al on "Distributive Justice Across Generations" later in this issue.)

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Avoidance of ethical decisions (i.e., passive euthanasia or doing nothing) is in itself a decision. It is hoped that there are reasonable methods to distinguish among infants inside the boundaries to prepare for the slippery slope where "all values are subject to social worth assessments." 36 The high emotional and economic cost to family and society justifies an attempted differentiation of infants whose defects are extensive or whose prognoses are so poor that future personal and social interaction is not possible, and, therefore, CPR should be withheld. The three most common diagnoses in which ethical considerations enter into CPR decisions are (1) infants with severe congenital defects, (2) extremely low birthweight infants, and (3) infants with severe perinatal asphyxia. INFANTS WITH SEVERE CONGENITAL ANOMALIES

The ethics involved in resuscitation decisions for infants with severe congenital anomalies is complex, with myriad issues and approaches. One needs to consider the morality and ethics of decision making; value judgments; legal considerations; the viewpoints of parents, physicians, and hospital staff, and an a priori approach to certain recognizable anomalies or patterns of malformation. As knowledge, skills, and technology have advanced, difficult ethical problems have emerged. Infants with congenital anomalies that previously were incompatible with life now can be kept alive with heroic interventions, but usually the underlying defect and its neurologic consequences cannot be ameliorated. Because of advances in perinatology, neonatology, and pediatric surgery, the public is presented with unprecedented choices about the kind and degree of effort to save or to end fetal and newborn life. Issues Concerning Neonatal Resuscitation In the DR, resuscitation is considered and includes a series of specific interventions to assist the infant in transition from the womb to extrauterine life. It is also used when death will occur without it, but this use is less frequent. Because resuscitation is not begun does not necessarily mean that the infant will die. Withholding resuscitation in the DR, however, may result in a poorer outcome owing to the added consequences of hypoxic-ischemic encephalopathy and multisystem organ injury. In their rejection of antenatal DNR orders, Yellin and Fleischman47 urge physicians to check that infants' surrogates have the babies' best interests in mind and insist that physicians must act according to their "independent beneficence" obligation to the baby. Therefore, the withholding of treatment must await assessment of the infant at birth. If the physician does not agree with or is unsure of the antenatal diagnosis, Yellin and Fleischman urge resuscitation and reassurance to parents that the decision to start treatment will not obligate them to continue treatment.

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Morality/Ethics of Decision Making

Any discussion of the ethics of neonatal CPR warrants a brief review of terms and ethical perspectives. Moral implies what a person ought to do in a given situation. In medical ethics, physicians analyze reasoning about moral problems and decide if that reasoning can be recommended to other clinicians. The medical literature cites several ethical arguments that pertain to the decision to terminate or withhold CPR from a newborn.12, 13, 1s Following deontologic reasoning, physicians would have a duty to avoid acts that are intrinsically wrong. Ramsey,1 2 using deontologic thinking in his arguments, suggests that if physicians will not perform infanticide (the killing of an infant after birth), they should not perform abortions for the same defect. In deontologic thinking, humanhood is a gift of God. In consequentialist/utilitarian thinking, man has a duty to increase good and reduce harm to living persons. Employing a consequentialist perspective, Joseph Fletcher supports abortion for a prenatal diagnosis of a significant defect. He rejects moral distinctions between acts of commission and omission and even sets aside traditional restraints against infanticide for defective infants. In consequentialist thinking humanhood is a human choice. 12, 13 Unfortunately, the Hegelian point of view, "what is useful is right," was taken to a ghastly extreme by the Nazi regime as described by Alexander in 1949. What started as a propaganda campaign to change compassionate attitudes toward the chronically ill became the science of euthanasia of the chronically sick and mentally defective, and eventually the systematic elimination of any politically undesirable group. The mediating position between deontologic and consequentialist thinking is that proposed by John Fletcher. 12 This mediating position resists absolutisms. Ramsey and Joseph Fletcher do not delineate morally relevant differences between the fetus and the newborn with the same degree of defect. On the other hand, John Fletcher proposes that the newborn is a separate individual from the mother and deserves protection. The defective newborn is the same being but at a different stage of development. The separate physical existence from the mother confronts society with a human being with independent moral claims. John Fletcher proposes that the physician must represent the interests of the newborn. As more successful fetal interventions are described, the physician may begin to represent the fetus to its parents and society as well. Using this approach, John Fletcher prescribes ethics that apply to most cases with an understanding that there will be certain cases in which exceptions will be made. One extreme position could be that every fetus is already human so there would be no rational grounds for abortion. The other extreme position would withhold human status until quality-of-life standards have been passed. 12, 13 John Fletcher also proposes other arguments against euthanasia, such as that it is potentially brutal to those who participate in it and has destructive social consequences. A society that supports acceptance of

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defective newborns nurtures of in and reinforces a child's basic trust. 13 The passive euthanasia of an infant with Down syndrome and duodenal atresia highlights the crucial issue of whether the existence of the infant lays moral claim that supersedes a mother's desires that are served by abortion. In this case, Gustafson18 notes two positions in the development of morality that run counter to one another. One argument is that desires of the ego are grounds for moral or legal claims, or, "what I want is right." The other position increasingly limits individual desires and wants. Equals shall be treated equally and, given the absence of a certain quality, the value of that individual is not sufficient to maintain life. 18 Value

On what grounds, according to what criteria, and determined by whom would a physician withhold treatment from a defective newborn? The Judea-Christian attitude is that life is a basic and precious good, a good to be preserved as the condition of other values. The meaning, substance, and consummation of life are found in human relationships emphasizing the qualities of justice, respect, concern, compassion, and support. Without these values, life is a relative good and the duty to preserve it a limited one. Thus, under Judea-Christian beliefs, a guideline in decision making would be the potential for human relationships. That potential, mired in underdevelopment because of the struggle to survive, raises the question about whether this worldly existence offers an individual infant any hope of sharing those values for which physical life is a fundamental condition. The Judea-Christian attitude is the middle path between vitalism and medical pessimism (that which kills when life seems too burdensome or useless). 27 What else does this society value? Intelligence, autonomy, and productivity are highly valued in our society. In 1970 the potential absence of these qualities was part of the foundation determining the decision for passive euthanasia of an infant with Down syndrome and duodenal atresia in a highly publicized case. 18 Considerations

In 1974, an American Medical Association (AMA) House of Delegates proclamation presented two positions on end-of-life issues. First, the intentional termination of life by another was contrary to the medical profession and the AMA. Second, the cessation of extraordinary means to prolong life with clear evidence that death was imminent was a decision for the patient and the family with physician input. This proclamation set forth organized medicine's position rejecting active euthanasia (mercy killing) and accepting passive euthanasia (withholding or

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withdrawal of support). Later in 1982 the Presidential Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research suggested a model of shared decision making between physician and patient.7 The 1984 Federal Child Abuse Amendments (FCAA) were drafted to ensure a balance between the right to life of imperiled infants and "whatever interests these same individuals had in withholding unwarranted medical interventions." 7 Reasonable medical judgment, under the FCAA statute, requires physicians to choose and direct medical care with the following exceptions: (1) The infant is chronically and irreversibly comatose; (2) the provision of treatment would prolong dying; and (3) treatment would be futile in terms of the survival of the infant.7 The 1989 Civil Rights Law, however, mandated medical care for every child in all but the most extreme cases and interprets the final exception in the FCAA: if treatment is provided that is virtually futile, it is inhumane. Moreover, every state imposes on parents a duty to provide medical care regardless of their child's physical or mental characteristics but does not require that all infants be kept alive as long as technology allows.7 Homicide by omission is the failure to discharge a legal duty to another person that causes that person's death: if intentionally withheld, first- or second-degree murder; gross carelessness, involuntary manslaughter. In dealing with a defective infant, the degree of homicide by omission is dependent on the extent of premeditation. Withholding medical care by parents is child abuse and the physician who knows and fails to report it commits a misdemeanor crime in 20 states. Because of the misdemeanor manslaughter rule, if this failure causes the child's death, the physician is responsible also. 36 The physician's duty derives from contract law; the physician contracts with the parents to undertake the care of the child. Under the law of third-party beneficiary contracts, parties contracting for services to another cannot terminate services to a minor if the minor would be substantially harmed. If the contract includes "only if normal," it would not apply to a defective child. 36 Clark7 reviewed six reported cases since 1984 involving the withdrawal or withholding of life support as well as the legal standards in the 50 states and the District of Columbia. Five states adopted specific language that parallels the federal definition of medical neglect and abuse as defined by FCAA. The general abuse and neglect statutes of the other 45 states and the District of Columbia support a charge of child abuse for the denial of medical treatment.7 In all six reported cases concerning the withdrawal of life support in a child, there was no majority opinion. The parents were free to consider quality-of-life issues and the courts recognized the rights of parents contrary to FCAA. 7 The Rosebush court decision (In re Joelle Rosebush, 491 NW2d 1377 [Mich App 1992]) upheld the right to withhold or withdraw life-sustaining treatment as an aspect of common law doctrine of informed consent. Parents were appropriate surrogates to exercise this right for their children. In addition, it was suggested that decisions occur in the clinical setting with the courts available to assist in impasse situations.7

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Thus, case law has supported patient- and family-directed care as the legal standard and not the federal standard. Physicians should remember that the doctrine of informed consent obligates the physician to share medical knowledge and expertise with the individual or individuals granting consent.7 Of interest, parents who have actively killed a defective child often have been acquitted. No parent has been prosecuted for withholding care to a defective newborn. All physicians prosecuted for homicide in euthanasia to terminally ill patients have been acquitted. No doctor has yet been prosecuted for passive euthanasia of a defective newborn. Physicians and parents have been reported under state law, but no physician or parent has been convicted. 36 Parental Fetal movement, as well as changing social roles during pregnancy, prepares the parents to accept an independent existence, creates a value in the fetus, and creates an expectation of more value to come. The birth of a child with a severe congenital anomaly shatters the expectations of the parents and causes mourning for the loss of their dreamed normal child. Parents will experience the many stages of grief. They may have a prolonged shock stage and will need to hear information repeatedly. Parents may feel that they own their children, that their children are persons with full rights, or that they must act as trustees for their children. On the other hand, some parents may be so emotionally overwhelmed that they may not be capable of even seeing the child's defect and only view the child as a blessing. The implications of a severe congenital defect may not be fully understood and some parents may see this as a great burden for them. Parents may fear social and familial enslavement, psychological taxation, economic deprivation, and permanent stigmatization. 5• 8• 9 • 14 Physician Viewpoint Duff and Campbell9 believe that two philosophies influence decisions about withholding treatment for infants with severe congenital defects. One is a disease-oriented philosophy in which death is the extreme negative and life itself is all that matters. This philosophy demands aggressive policies for patient care. The other philosophy is person oriented, placing the quality of life as the primary concern. Therefore, some kinds of severely compromised living are considered worse than death. 9 In the circumstance of a defective child, the physician may feel tension as he serves two clients, the infant and the parents. Withholding medical care may be counter to the professional oath and allowing death to occur may be a poor ethical example. The physician's manner and

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tone may little disguise his own value preferences, and the physician may hold excessive power by limiting or controlling the information provided to the parents. Physicians may reduce these problems by consultation with one or more counselors with a different point of view. If the parental decision represents a conflict of interests, the physician has an independent duty to consult the court or to proceed without consent. A physician may fear prosecution. The physician may feel death is the right decision for certain severely defective children but may be unwilling or unable to share the agony of making a conscious choice for death. Discussion of euthanasia in families and hospitals has been taboo in the past. Physicians have competence to make moral decisions according to their own moral and other values but have no authority to impose their decisions on patients. Physicians need not attempt to maintain the life of every severely impaired newborn, but the parents and the physician should carry the ultimate responsibility for the decision, which should be made on the basis of best medical predictions concerning longevity and quality of life. 8 • 9• 14• 43

Hospital Staff Viewpoints

Similar to physicians, hospital support staff have held varied views on the care of children with congenital anomalies. Duff and Campbell8 report staff attitudes that certain individuals have a right to die because they have little or no chance of achieving humanhood and little capacity to love or be loved and are kept in institutions ("dying bins") with nonexistent social participation, severe maternal deprivation, and need to escape a wrongful life-that fate worse than death. Some hospital staff have reported physicians and parents for prosecution for withholding or withdrawal of support, violating federal and state standards in their view. 8

Didactic Approach

A didactic approach might be to ask an expert in congenital anomalies his opinion about birth defects incompatible with life and to follow his advice. Kenneth Lyons Jones, chief of the Division of Dysmorphology and Teratology at the University of California in San Diego, stresses that clinicians must be able to make a diagnosis to answer the two most common questions asked by parents of defective children: What is the prognosis? And what is the recurrence risk? Table 1 is Jones's list of identifiable disorders or specific structural defects incompatible with life that may be diagnosed in the DR Before determining that a disorder or specific malformation is incompatible with life, it is important that the following requisites for nonintervention be met:

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Table 1. IDENTIFIABLE DISORDERS OR SPECIFIC STRUCTURAL DEFECTS INCOMPATIBLE WITH LIFE Hydranencephaly Anencephaly Holoprosencephaly 13 Trisomy syndrome 18 T risomy syndrome Triploidy Renal agenesis Sirenomelia Short-limb dwarfing syndromes Achondrogenesis types 1a and 1b Type II achondrogenesis-hypochondrogenesis Fibrochondrogenesis Atelosteogenesis Short-rib polydactyly syndrome, Saldinonoonan type Thanatophoric dysplasia Osteogenesis imperfecta type II Miscellaneous syndromes Lethal multiple pterygium syndrome Neu-Laxova syndrome Meckel-Gruber syndrome

Easily recognizable anomaly or pattern of malformation; it cannot be an unknown Lethal outcome or vegetative survival in 100% of affected infants; it cannot be a disorder such as Down syndrome Rapid laboratory confirmation of diagnosis is available: karyotype, ultrasound, CT scan, and so forth Single defect requiring heroic corrective or therapeutic measures to ensure survival, for example, renal agenesis Jones, however, does not believe that the DR is the place to do a careful physical examination, which is often necessary to determine if a child has a condition incompatible with life. The focus in the DR should be on resuscitation. As soon as the infant is stabilized and in the NICU, a careful examination should be done to identify the disorder or structural defects that are listed in Table 1. According to Jones, physicians must present the salient facts to parents whose child has a lethal condition. Physicians should support the couple in their decision and not judge them. Jones reminds us of the inherent strength that most people have to make decisions that are right for them. (Kenneth Lyons Jones, MD, personal communication, January 1996.) Active Versus Passive Euthanasia Withholding cardiopulmonary resuscitation in the case of an infant with a severe congenital anomaly presents a dilemma for physicians because the prevailing moral policy in the NICU is to give the newborn

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the benefit of the doubt-resuscitate now and decide later. According to Rachels,34 if a physician lets a patient die for humane reasons (passive euthanasia), he is in the same moral position as if he had given a lethal injection for humane reasons (active euthanasia). In passive euthanasia, one performs an action by not performing another action. Letting someone die may be assessed as wise or unwise-it has moral implications. 34 Descriptions of the passive euthanasia of the infant with Down syndrome and duodenal atresia are painful to read or watch as the infant dies of starvation and dehydration 15 days after the decision was made ("Who Should Survive" [videotape], Joseph P. Kennedy Foundation, Washington, DC, 1971). Arguments abound, not only about the ethics of the decision but also about the cruelty of this particular death. 12, rn, 27, 34 It has been suggested that active euthanasia would have been the less cruel option. 27 The AMA statement of 1974 essentially approves passive euthanasia, yet Rachels 34 makes the argument that there is no moral difference between passive and active euthanasia. Many physicians would reject active euthanasia because of a negative ethical assessment of the action and its consequences. Allowing an infant with a severe congenital anomaly to die by withholding treatment while providing pain and comfort support can be ethically justified for reasons of mercy to the infant and the relief of meaningless suffering of the parents and the medical team. "The crucial difference between euthanasia and allowing to die is that the self-restraint of the latter is more consistent with ethical and legal norms that physicians and parents do no harm to the infant." 12 Some physicians have proposed the use of a set of authoritative criteria describing limited circumstances in which ordinary care may be withheld from newborn infants with a defect and a process of decision making that minimizes the risk of mistakes or abuse, and that these criteria be reviewed periodically.27 EXTREMELY PREMATURE INFANTS (MICROPREMIES)

Frequently, pediatricians are placed in the position of determining if resuscitation of an extremely premature newborn is warranted. The DR is the locale where this decision is most likely to occur; it is also the place where clinicians are least likely to be objective. The decision to undertake resuscitation is often related to an infant's estimated gestational age, birth weight, or both. With the decision to resuscitate comes the long-term commitment for the care of this child. The emotional and financial investment is very high. At a time when media attention is directed toward our smallest miracle survivors and frequently creates an unrealistic air of expectation amongst the lay population, health care providers are faced with doing more with less. Fewer dollars are devoted toward health care, which limits the benefits that are offered to these patients, many of whom have significant ongoing medical needs after their initial hospitalization. Often treatment decisions are guided by anecdotal and accumulated experience. Statistics gathered on extremely

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premature or very low birthweight infants prior to the FDA approval of exogenous surfactant in 1990, however, may not reflect the improvement in survival and decrease in handicaps that has been achieved with surfactant and other recent advances in technology and patterns of care. CPR Decisions Based on Gestational Age There appears to be a growing consensus about the limit of viability in terms of gestational age. In the Sanders et al40 1995 survey of neonatologists, there was virtual unanimity when counseling parents about the lack of viability of a fetus of less than 23 weeks' gestation. Sanders et al40 reported that 90% of survey respondents advised parents that fetal death was likely in 75% to 100% of infants of 23 weeks' gestation, and 50% of neonatologists used the same mortality percentages for infants at 24 weeks' gestation. Fanaroff et al, 11 in their 20-month review in 1991 and 1992, found that among inborn infants of 23 weeks' or less gestational age, the survival to discharge was 19% but rose to 47% and 68% at 24 and 25 weeks, respectively. Similarly, questioning the limit of viability in the population of infants born at 22 to 25 weeks' gestation from 1989 to 1991, Allen et al2 described their improved survival with increasing gestational age. The Johns Hopkins group defined survival as the number of infants born at a given gestational age who survived 6 months. At 22 weeks' gestation, there were no survivors of 22 live-born infants, and only 16.7% of live borns survived having been delivered at 23 weeks' gestation. Once the gestational age had achieved 24 weeks, survival was 56% and rose to 80% for those infants of 25 weeks' gestation. Severe intracranial hemorrhage rates (grades 3 and 4) were reported to be 50% and 43% for gestations of 23 and 24 weeks respectively. Milligan et al,2 8 in attempting to develop guidelines for intervention for fetal indications as well as obtain outcome data for family members, evaluated 730 consecutive live births between 23 and 32 weeks' gestation in 1984. Their data for infants between 23 and 25 weeks born in the presurfactant era are included in Table 2 and resulted in the opinion that intervention was indicated for infants of 25 weeks' gestation or more, though resource utilization for the infants at or below 25 weeks' gestation was cause for concern. Hack et al2° reported outcomes from the seven National Institute of Child Health and Human Development

Table 2. SURVIVAL BY WEEKS OF GESTATION

Fanaroff et a1 11 Allen et al2 Milligan et al2 8 Ochsner Hack and Fanaroff NA = not available.

22%

23%

24%

25%

NA

19 17 14 0 23

47 56 39 58 34

68 80 64 66 54

0 NA

0 NA

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Neonatal Intensive Care Network centers. Survival data collected from 1765 very low birthweight inborn infants born between November 1987 through October 1988 revealed a wide range of survival statistics shown in Table 2. From January 1991 through August 1995, the Ochsner NICU has cared for 72 infants of gestations known to be less than 26 weeks' gestation. Survival to discharge rates according to gestational age are noted in Table 2. Review of these data with our perinatal/neonatal staff has led to a practice of not resuscitating infants with a known gestation of 22 weeks or less. A fetus of 23 weeks' gestation is considered a possible but very unlikely survivor. All infants known or suspected to be at least 24 weeks' gestation are resuscitated unless they have a previously diagnosed lethal anomaly. When feasible, the family and neonatal staff discuss the ramifications of resuscitating an infant of any given gestation. Included in these discussions are the likelihood of survival as well as the major initial obstacles the infant is likely to encounter (respiratory distress, intracranial hemorrhage, feeding intolerances) to survive outside the womb. The family also is educated about possible long-term sequelae of prematurity that include but are not limited to chronic lung disease, auditory dysfunction, visual impairment, and neurodevelopmental delay. Basing the decision to resuscitate on gestational age is limited by the accuracy with which the gestational age is determined. The potential for incorrect gestational age assessment in the DR is high, as the time to perform this evaluation is limited and the assessment tools imprecise. Previously used markers of nonviability, such as fused eyelids, are probably invalid (Fig. 1). 4 Gestational age assessment instruments, including the new Ballard score, have a variance of at least 10 days at gestations less than 26 weeks. 4 Variances of as little as 2 weeks may result in the survival rate improving from 0% to in excess of 50%. Although the exact date of conception may be known for a limited number of pregnancies, dating a gestation by uterine size alone is imprecise. By using the crown-rump length, uterine sonography offers some verification of gestational age, especially when performed during the first trimester ( ± 5 days at 12 weeks' gestation or less). Beyond this time, norms for head circumference, abdominal circumference, and femur length used in combination may help in approximating gestational dating. 21 Fetal growth and fetal maturation may be altered by intrauterine stresses in the same or opposite directions and in varying degrees. Although physical markers, such as fused eyelids, may not indicate nonviability, these signs may reflect maturational immaturity of other organ systems. This uncertainty of estimating gestational age should direct the practitioner to evaluate multiple parameters for validation. CPR Decisions Based on Weight

An infant's birthweight provides the physician with an objective measurement from which all further management can ensue. Rather

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than weighing an infant in the nursery, many delivery suites now have been equipped with scales (some with weights in 1-g increments) to provide caregivers with this immediate, frequently essential information. Calculation of medicine dosage, including exogenous surfactant, can be performed once the patient's weight is known. Although the weight of the patient is a precise measurement, it is inherently affected by obstetric factors. Maternal genetic constitution along with certain medical conditions may result in an infant being small, appropriate, or large for gestational age. 25 Intrauterine sonography has demonstrated the wide variation in weight at various gestational ages. Romero et al's 37 graph of estimated fetal weight (Fig. 2) shows that a fetus at 22 weeks may weigh as little as 400 g or as much as 700 g (5th-95th percentiles). 37 Despite these limitations, birthweight has been suggested as one of the parameters used in assessing who should be resuscitated. Although survival of infants who have birthweights of less than 400 g is well documented (most patients being small for gestational age), 16• 29 most individual and collaborative studies have examined this issue using birthweights above 500 g. In 1980, Schechner41 concluded that a hands-off approach for the population of infants having a birthweight of less than 750 g be adopted owing to the poor rate of survival as well as the high percentage of neurologically handicapped infants. Six years later in their observational study, Hack and Fanaroff19 reached a different conclusion, believing that "early aggressive management including intubation and ventilatory support" was warranted in infants having a birthweight of 500 to 750 g. In a collaborative study that included 4279 inborn infants, Fanaroff et

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al 11 reported that for patients in the weight group of 501 to 1500 g at birth, there was an increase in survival over the 5 years from 1987 to 1992. This did not result in an increase in the amount of medical morbidity, only an increase in the absolute number of survivors. This is similar to other reports issued in the 1980s. 22, 32, 36 Survival improved from 74% in 1987 and 1988 to 81% in 1991and1992 in the postsurfactant era. The rate of severe intracranial hemorrhage in the collaborative study was 11 %. At Ochsner Foundation Hospital from January 1991 through July 1995, we have cared for 197 inborn infants in the birthweight range of 501 to 1500 g, with an overall survival rate of 87%. This survival rate compares favorably with other reports (Table 3), as does the Ochsner 7% rate of severe (grades 3 and 4) intracranial hemorrhage in this group of patients weighing over 1000 g, although the survival rate for infants less than 1000 g was somewhat lower. The rate of severe intracranial hemorrhage was 18% for the entire group whose birthweight was below 1500 g. The American Academy of Pediatrics, Committee on Fetus and

Table 3. INBORN WEIGHT-RELATED SURVIVAL RATES 501-750 g (%) 751-1000g(%)1001-1250g(%)1251-1500 g (%) Fanaroff et al Sachs and Ringer38 Ochsner Hack and Fanaroff19 11

44

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Newborn, and the American College of Obstetricians and Gynecologists, Committee on Obstetric Practice, issued recommendations (with the caveat that these did not constitute an exclusive course of treatment) in November 1995 that echoed many of the concerns that obstetricians and neonatologists share.3 Maternal intervention, mode of delivery, decision and extent of resuscitative efforts, and discontinuance of therapy were addressed. The statement was centered around family education. By providing parents with information, clinicians offer them the opportunity to join the medical team in the management of their newborn's treatment. Informed decision making becomes possible from this point forward. Cultural and ethnic diversity should be anticipated with counseling that respects a family's desires (i.e., baptism, blood product usage in the case of a Jehovah's Witness patient, and so on). Compassion and dignity for an infant and their family should be maintained at all times. Who Should Make the Decision?

At the present time, society has been unwilling or unable to suggest a remedy to the dilemma of providing care for our tiniest patients. Parental desires, quality of life, long-term survival, and financial responsibility all are issues intimately related to the consequences of preterm delivery. Before educating parents, the physician must first come faceto-face with his own emotions concerning issues surrounding the very low birthweight infant. Often the attitudes of obstetricians, pediatricians, and neonatologists lead to practice patterns that are self-fulfilling prophecies. Health care professionals should begin family counseling early in the hospitalization-prior to birth when appropriate and time permits. This education for the parents should be ongoing, as they are the ultimate decision makers for their child yet are usually ill prepared for such a task. The family should be made aware that decision making continues beyond the first few critical hours and that their child's future treatment will be based on almost continuous reassessments. The medical team should always be a source of support in addition to significant others, including clergy when requested. Once the decision to resuscitate has been made, the procedure should be performed with the utmost diligence in an attempt to limit the complications of extrauterine preterm survival. Although optimal resuscitation does not guarantee a normal outcome, it does provide the patient and the family with that possibility. At some point, if future treatment is considered futile, the option of either limited intervention or withdrawal of therapy should be offered to families. The obvious solution, prevention of preterm delivery, is the ultimate objective. When preserving gestation is not possible because of maternal or fetal indications, limitation of all the comorbidities related to prematurity is the next most desired goal. Antenatally, the use of corticosteroids to enhance fetal lung maturity and therefore obviate the need for significant respiratory support, has improved the quality of life for the

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littlest survivors. Recent advances in neonatal therapies as dramatic as exogenous surfactant and as subtle as the removal of noxious stimuli all play a role in maximizing neonatal outcome. The success in this endeavor is evidenced by the lack of increasing handicap rates despite the increase in very low birthweight survival. Despite all medical successes in the treatment of critically ill infants, physicians are still faced with the dilemma of where to draw the line. Once therapy is initiated, justification for its continuation should be frequently assessed. Prolongation of the dying process serves no purpose unless it is performed to allow a family to spend time saying goodbye to a little loved one. Remembering to first do no harm and, when appropriate, allowing death to occur with dignity should be at the heart of all decision making. THE SEVERELY ASPHYXIATED INFANT

The physician called on to resuscitate a severely asphyxiated infant faces many of the same ethical dilemmas noted in decisions regarding infants with severe congenital anomalies and "micropremies." There are no clear guidelines concerning when not to start or when to terminate CPR. The issues are not only whether the CPR will be successful, but whether if successful, the infant will be severely damaged. A brief review of the physiologic experiments on which we base our (inadequate) knowledge of asphyxia and brain damage may serve as a basis for decision making. Physiology of Asphyxia

Asphyxia is a complex physiologic event, usually consisting of hypoxia (partial absence of oxygen) or anoxia (total absence of oxygen) and ischemia leading to a shift in the body's metabolism to anaerobic pathways. This results in the creation of metabolic acidosis that, when severe enough and in conjunction with respiratory acidosis, causes hypotension and multisystem organ damage. A series of primate experiments beginning in 1957 indicated that when fetal monkeys were subjected to anoxia for 4 to 25 minutes, the following conclusions could be drawn. 35 An anoxic insult of less than 8 minutes might not cause brain damage. More than 10 minutes of anoxia resulted in neuropathologic findings that increased in severity with the duration of the anoxia. Anoxia for 20 to 25 minutes was usually fatal. Low26 has summarized these findings (Fig. 3). The effects of hypoxia on the fetal brain were examined in a series of experiments in the 1960s.30 Monkeys were exposed to moderate degrees of hypoxia for 3 to 5 hours and then resuscitated. Evidence of brain injury was more variable in these experiments. When fetal acidosis was severe (arterial pH< 7.00), however, and hypotension was present,

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Time Figure 3. Effect of anoxia on the fetal brain. (From Low JA: The relationship of asphyxia in the mature fetus to long-term neurologic function. Clin Obstet Gynecol 36:82, 1993; with permission.)

neuropathologic findings were similar to severe anoxia. The obvious difference between anoxia and hypoxia is the variable duration of events in the hypoxia experiments that resulted in brain injury (Fig. 4). 26 The duration of hypoxia leading to brain injury ranged from 1 to 3 hours, depending on the severity of the hypoxia. Similarly, the threshold of morbidity to the threshold of mortality ranged from 1 to 3 hours.

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Time Figure 4. Effect of hypoxia on the fetal brain. (From Low JA: The relationship of asphyxia in the mature fetus to long-term neurologic function. Clin Obstet Gynecol 36:82, 1993; with permission.)

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These two classic experiments demonstrated that brain injury may occur with a short period of anoxia or a sustained period of hypoxia. The threshold at which neuropathologic changes occur seems to be a pH less than 7.00 with concurrent hypotension. It is estimated that intrapartum fetal asphyxia occurs as often as in 2% of deliveries. Most of these children will have no evidence of brain injury because cerebral palsy secondary to intrapartum asphyxia in term infants accounts for only 1 to 2 cases per 10,000 live births. 26 The key to this tolerance is the placental and fetal cardiovascular compensatory response to asphyxia that maintains cerebral blood flow and aerobic metabolism. The normal fetus at term may have a compensatory phase, subject to the severity of the hypoxia, that lasts for hours. The post-term or growth-retarded fetus or a fetus with a less-than-optimal placental unit (secondary to disorders such as maternal diabetes, maternal cigarette smoking, or pregnancyinduced hypertension) will have a markedly reduced compensatory phase. Markers for Severe Asphyxia

Markers commonly used to identify birth asphyxia are not good predictors of brain injury or death. 30 Low Apgar scores at 1 and 5 minutes are not good predictors of outcome. Apgar scores of less than 3 at 10 to 15 minutes, however, were good predictors of brain injury or death. 30 Marked fetal bradycardia (rate < 60 beats per minute for 10 mintues or more) has been associated with increased risk of cerebral palsy. Although low cord arterial pH has been considered the best means to identify intrapartum asphyxia, the relationship to neurologic injury does not reach significance until the pH is less than 7.00. 16 Some investigators 26 doubt the relationship of even severe acidosis to outcome. When severe acidosis (pH< 7.00), however, is secondary to a metabolic component (base deficit 2': - 20), the prognosis is more ominous than if hypercarbia is the major component of the acidosis. In a small series of infants with a pH less than 7.00 and very low 1- and 5-minute Apgar scores, the only infants who had eventual brain injury were two children with identifiable severe prenatal problems, highlighting again the importance of fetal compensatory mechanisms. 46 When several markers occurred together, however, Ellenberg and Nelson10 identified a group of infants who could be identified and predicted to have brain injury. Thus the combination of low Apgar scores, signs of neonatal encephalopathy, and seizures predicted a high rate of cerebral palsy. 10 From a multitude of studies, it seems some judgments can be made. First, a low Apgar score at 1 minute is not a useful marker. Jain et al23 reported on the CPR of term infants with Apgar scores of 0 at 1 minute. Two thirds of 93 infants left the DR alive. Forty-two percent of these infants died in the neonatal period and 58% were discharged home. Developmental assessment of 23 of the 33 long-term survivors revealed normal outcome in 61.7%, abnormal results in 26%, and suspect status

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in 13%. Of the 58 infants who had an Apgar score of 0 at 10 minutes or less, 57 died and the one lone survivor was abnormal. Thus, late Apgar scores of 0 at 10 to 20 minutes are highly suggestive of futile CPR or abnormal outcome. Two separate papers have demonstrated that absence of spontaneous respirations by 30 minutes of age indicated eventual death or abnormal outcome. 42' 44 In Perlman and Risser's 33 recent review of CPR in the DR, of five term infants requiring chest compressions or epinephrine with an arterial cord pH of less than 7.00, two died and three survivors showed neurologic abnormalities. The authors remind us that CPR (i.e., using chest compressions or epinephrine) in the DR is a rare event (0.12% of deliveries) and failure of the infant to respond is often the result of ineffective or improper ventilatory support. 33 Jain and Vidyasagar24 have created a useful algorithm for the resuscitation of infants born with no heart rate (Fig. 5). From the available evidence, it seems reasonable to discontinue CPR in a term infant if cord arterial or neonatal arterial pH is less than 6.8 and base deficit is at least minus 20; apgar score is 0 at more than 10 minutes; or there are no spontaneous respirations at 30 minutes. Knowledge of prenatal conditions (e.g., prolonged severe intrauter-

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Figure 5. Proposed algorithm for management of apparently stillborn infants. (From Jain L, Vidyasagar D: Controversies in neonatal resuscitation. Pediatr Ann 25:10, 1995; with permission.)

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ine bradycardia, pregnancy-induced hypertension) that might alter the neonate's compensatory mechanisms also should be taken into account when making CPR decisions. Often CPR of asphyxiated infants is an emergency situation, denying the resuscitating physician a chance to know the wishes of the parents. In this situation, physicians act with the "presumption of consent" in the DR if they possess the appropriate level of competence and use "reasonable judgment."47 Physicians functioning in an ethical manner should meet both of these qualifications. The appropriate level of competence should be achieved through a continuing effort to maintain resuscitation skills by practice of techniques and completion of appropriate refresher courses such as the Neonatal Resuscitation Program.6 Recertification in this program should be achieved every 2 years. Moreover, the Guidelines for Perinatal Care, third edition, requires one skilled resuscitator to be present at every delivery. 15 "Reasonable judgment" is the application of these skills by a knowledgeable clinician who understands the medical, social, legal, and economic issues surrounding the resuscitation of infants with severe congenital anomalies, extremely low birthweight infants, and severely asphyxiated neonates. This review, it is hoped, will provide decision makers the information necessary in these critical situations. ACKNOWLEDGMENTS The authors wish to thank Kenneth Lyons Jones, MD, and Robin Renee McKenney, MSGC, for their invaluable assistance in the preparation of this manuscript.

References 1. Alexander L: Medical science under dictatorship. N Engl J Med 241:39, 1949 2. Allen MC, Donohue PK, Dusman AE: The limit of viability-neonatal outcome of infants born at 22-25 weeks' gestation. N Engl J Med 329:1597, 1993 3. American Academy of Pediatrics Committee on Fetus and Newborn: Perinatal care at the threshold of viability. Pediatrics 96:974, 1995 4. Ballard JL, Khoury JC, Wedig K, et al: New Ballard score, expanded to include extremely premature infants. J Pediatr 119:417, 1991 5. Benfield DG, Lieb SA, Vollman JH: Grief response of parents to neonatal death and parent participation in deciding care. Pediatrics 62:171, 1978 6. Bloom R, Cropley K: In Chameides L (ed): Textbook of Neonatal Resuscitation. Dallas, American Heart Association, 1990 7. Clark FI: Intensive care treatment decisions: The roots of our confusion. Pediatrics 94:98, 1994 8. Duff RS, Campbell AGM: Moral and ethical dilemmas in the special-care nursery. N Engl J Med 289:890, 1973 9. Duff RS, Campbell AGM: On deciding the care of severely handicapped or dying persons: With particular reference to infants. Pediatrics 57:487, 1976 10. Ellenberg JH, Nelson KB: Cluster of perinatal events identifying infants at high risk for death or disability. J Pediatr 113:546, 1988 11. Fanaroff AA, Wright LL, Stevenson DK, et al: Very low birthweight outcomes of the National Institute of Child Health and Human Development Neonatal Research Network, May 1991 through December 1992. Am J Obstet Gynecol 173:1423, 1995

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12. Fletcher J: Abortion, euthanasia and care of defective newborns. N J Med 292:75, 1975 13. Fletcher JC: Ethics of therapeutic leadership. Alabama journal of Medical Science 19:156, 1982 14. Fost N: Counseling families who have a child with a severe congenital anomaly. Pediatrics 67:321, 1981 15. Freeman RK, Poland RL (eds): Guidelines for Perinatal Care, ed 3. Elk Grove Village, IL, American Academy of Pediatrics, 1992, p 83 16. Ginsberg HG, Goldsmith JP, Stedman CM: Survival of a 380-g infant [letter]. N Engl J Med 322:1752, 1990 17. Goldaber KG, Gilstrap LC III, Leveno KJ, et al: Pathologic fetal acidemia. Obstet Gynecol 78:1103, 1991 18. Gustafson JM: Mongolism, parental desires, and the right to life. Perspect Biol Med 16:529-557, 1973 19. Hack M, Fanaroff AA: Changes in the delivery room care of the extremely small infant (< 750 g): Effects on morbidity and outcome. N Engl J Med 314:660, 1986 20. Hack M, Horbar JD, Malloy MH, et al: Very low birthweight outcomes of the National Institute of Child Health and Human Development Neonatal Network. Pediatrics 87:587, 1991 21. Hadlock FP, Deter RL, Harrist RB, et al: Sonographic detection of fetal intrauterine growth retardation. Perinatology /Neonatology 7:21, 1983 22. Herschel M, Kennedy JL Jr, Kayne HL, et al: Survival of infants born at 24-28 weeks' gestation. Obstet Gynecol 60:154, 1982 23. Jain L, Ferre C, Vidyasagar D, et al: Cardiopulmonary resuscitation of apparently stillborn infants: Survival and long-term outcome. J Pediatr 118:778, 1991 24. Jain L, Vidyasagar D: Controversies in neonatal resuscitation. Pediatr Ann 25:540, 1995 25. Kramer MS: Intrauterine growth and gestational duration determinants. Pediatrics 80:502, 1987 26. Low JA: The relationship of asphyxia in the mature fetus to long-term neurologic function. Clin Obstet Gynecol 36:82, 1993 27. McCormick RA: To save or let die. JAMA 229:172, 1974 28. Milligan JE, Shennan AT, Hoskins EM: Perinatal intensive care: Where and how to draw the line. Am J Obstet Gynecol 148:499, 1984 29. Muraskas JK, Carlson NJ, Halsey C, et al: Survival of a 280-g infant. N Engl J Med 324:1598, 1991 30. Myers RE: Two patterns of perinatal brain damage and their conditions of occurrence. Am J Obstet Gynecol 112:246, 1972 31. Nelson KB, Emery ES III: Birth asphyxia and the neonatal brain: What do we know and when do we know it? Clin Perinatal 20:327, 1993 32. Nickel RE, Bennett FC, Lamson FN: School performance of children with birthweights of 1000 g or less. American Journal of Diseases of Children 136:105, 1982 33. Perlman JM, Risser R: Cardiopulmonary resuscitation in the delivery room. Arch Pediatr Adolesc Med 149:20, 1995 34. Rachels J: Active and passive euthanasia. N Engl J Med 292:78, 1975 35. Ranck JB, Windle WF: Brain damage in the monkey, Macaca mulatta by asphyxia neonatorum. Exp Neural 1:130, 1959 36. Robertson JA, Fost N: Passive euthanasia of defective newborn infants: Legal considerations. J Pediatr 88:883, 1976 37. Romero R, Pilu G, Jeanty P, et al (eds): In Prenatal diagnosis of congenital anomalies. Norwalk, CT, Appleton & Lange, 1988, p 488 38. Sachs BP, Ringer SA: Intrapartum and delivery room management of the very low birthweight infant. Clin Perinatal 16:809, 1989 39. Saiga S, Rosenbaum P, Stoskopf B, et al: Outcome of infants 501-1000 g birthweight delivered to residents of the McMaster health region. J Pediatr 105:969, 1984 40. Sanders MR, Donohue PK, Oberdorf MA, et al: Perceptions of the limit of viability: Neonatologists' attitudes toward extremely preterm infants. J Perinatal 15:494, 1995 41. Schechner S: For the 1980s: How small is too small? Clin Perinatal 7:135, 1980 42. Scott H: Outcome of severe birth asphyxia. Arch Dis Child 51:7, 1976

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43. Shaw A, Randolph JG, Manard B: Ethical issues in pediatric surgery: A national survey of pediatricians and pediatric surgeons. Pediatrics 60:588, 1977 44. Steiner H, Nelligan G: Perinatal cardiac arrest: Quality of the survivors. Arch Dis Child 50:696, 1975 45. Veatch RM: Deciding against resuscitation, encouraging signs and potential dangers [editorial]. JAMA 253:77, 1985 46. Winkler CL, Hauth JC, Tucker M, et al: Neonatal complications at term as related to the degree of umbilical artery acidemia. Am J Obstet Gynecol 164:637, 1991 47. Yellin PB, Fleischman AR: DNR in the DR? J Perinatal 15:232, 1995 Address reprint requests to

Jay P. Goldsmith, MD Department of Pediatrics Ochsner Clinic and Alton Ochsner Medical Foundation 1514 Jefferson Highway New Orleans, LA 70121