End-of-Life Care on the NICU

4. End-of-Life Care on the NICU COMPLEX - Agonizing - Difficult - Unique - Educational - Humbling • Uncertainty in outcomes/prognosis • Defining futility • Paucity of time spent learning to help our patients die - training is spent in saving lives • Bad things happening to wonderful people NEVER, EVER gets any easier

5. Decision to limit or withdraw treatment: parents in collaboration-partnership with physician, nursing and health care professional staff, all acting in the best interests of the infant Support: family, friends, clergy, support group, others Ethical Decision Making on the NICU Neonatology lacks the “holy grail” whereas an intervention/ approach to care will improve survival and decrease the prevalence of disability among survivors

6. End-of-Life Care on the NICU Caring Concerned Competent Compassionate Healthcare Team

7. Ethical Issues/Areas in Perinatal-Neonatal Medicine • Limits of viability: 22-24 weeks’ gestation • Congenital anomalies • Prenatal • Fetal surgery • Postnatal - genetic, multiple anomalies • Nonresponsiveness to therapy • Chronic lung disease • Perinatal distress • Intraventricular hemorrhage

8. Newborn Infants for Whom Ethical Decision-Making is Often Required • Extreme prematurity (limits of viability—22-24 weeks) — morbidity (CNS, pulmonary), gestational age • Full-term — severe perinatal asphyxia • Genetic disorders • Multiple congenital anomalies (e.g., trisomy 13)

9. Newborn Infants for Whom Ethical Decision-Making is Often Required • Hypoplastic left heart syndrome, complex cyanotic heart disease • Severe intraventricular hemorrhage • Requirements for “high technology” (transplant, ECMO) • Non-responsiveness to intervention (e.g., worsening chronic lung disease-ventilator dependent, short gut, sepsis)

10. Ethical Dilemmas in the NICU — Common Questions • Would you offer life-sustaining medical treatment at parents’ request in spite of your medical judgment that withholding treatment is the preferred (medical) course of action? • Does such treatment result in greater suffering? • Are parents of critically ill newborn infants equipped to make appropriate ethical decisions regarding their child? • How are these parents best equipped to make such decisions? • What is the role of the hospital ethics committee? • What is the role of the legal system in ethical decision making? State legislature?

11. Ethical Dilemmas in the NICU — Common Questions • What do you do if the parents’ wishes regarding their child’s care differ from yours and from the accepted medical care — the parents want “full support” or want “no resuscitation,” which is different from accepted standard of care? • Should the infant’s long-term prognosis (quality of life) affect decision making? • Should resource allocation (finances, beds, staffing) or psychosocial issues (e.g., breakup of a marriage) be part of the medical decision?

12. Ethical Dilemmas in the NICU — Common Questions • Who should be involved in medical decisions of withholding/withdrawing or sustaining care for an infant? Parents, family members (which ones)? Physician? Nursing? Other health care professionals (social worker, clergy)? Ethics committee? Courts? State legislature? • Should you provide fluids and nutrition as part of care to every infant, even when withholding or withdrawing support? Antibiotics? Treatment of hypotension? Analgesics for pain? • Is euthanasia in an infant with hopeless and unbearable suffering ever acceptable? (parental agreement, Netherlands)

13. Ethical Dilemma in Patient Care • Should we resuscitate a 24-26 week gestational age infant against parental wishes? • 25% chance of survival without disability at 25 weeks (12% at 24 weeks, 5-10% at 23 weeks) • Best interests of infant • NICU care: 3-4 months, reduced maternal contact, painful procedures, poor nutrition • Social influences: parents in 40s? Pregnancy- in vitro fertilization? Both parents desire intervention? Unplanned pregnancy? Parents young and undecided or “do everything”?

14. Ethical Issues/Areas in Perinatal-Neonatal Medicine - Not Discussed • Genetic testing/screening, fetal surgery • Cloning, assisted reproductive technologies • Patient refusal of treatment (obstetrics) • Selective reduction of fetuses • Termination of pregnancies • Selection determination in monochorionic twins (complicated) • Informed consent

15. Moral Principle of Nonmaleficence Above all else:DoNoHarm We need to convince our profession that its awesome technical power carries with it an equal responsibility to behave reasonably… From Silverman WA. Pediatrics 98:1182, 1996

16. Principle of Beneficence Do all to benefit the patient The well-being of the patient - primary goal of health care Patient-oriented-Value Human Life

17. Principle of Equity - Justice Obligation of society to patient Issues of limited resources Allocate resources equitably-No Discrimination on the Basis of Disability

18. Ethics and the NICU • Health care decisions must reflect the “best interests” of the infant • “Best Interests” • Subjective • Maximize benefits, minimize harm to the infant in proposed course of action and benefit/harm ratio is more favorable than with other courses of action

19. “Best Interests” of the Child in the NICU • Often translated into slogan, “better off dead” • Permanent handicaps justify a decision not to provide life-sustaining treatment only when they are so severe as to be of no net benefit to the infant…net benefit is absent ONLY if the burdens imposed on the patient by the disability or its treatment would lead a competent decision maker to choose to forego the treatment

20. Ethical Decisions in the NICU - Definitions • Futile: treatment that will NOT significantly extend life or postpone death • Beneficial: situation in which potential medical benefits of treatment clearly outweigh risks Peerzada JM, et al. J Pediatr 145:492, 2004

21. Withholding - omit a form of treatment not considered beneficial Withdrawal - remove treatment that has not achieved beneficial intent or is ineffective Ethics and the NICU Neonatology lacks the “holy grail” whereas an intervention/ approach to care will improve survival and decrease the prevalence of disability among survivors Equal from a moral, legal perspective

22. Is NOT giving epinephrine and doing chest compressions on a hypotensive, bradycardic premature infant on a ventilator and dopamine (withholding care) the same as removal of the endotracheal tube at one day, one week or one month chronological age (withdrawal) from a similar infant (futility) or from a full-term, physiologically stable infant with a severe neurologic insult (IVH-premature infant, asphyxia, chromosomal anomalies— quality of life?)? Ethical Dilemmas in the NICU Neonatology lacks the “holy grail” whereas an intervention/ approach to care will improve survival and decrease the prevalence of disability among survivors

23. Withdrawing support (e.g., ventilation) is often more emotionally charged and psychologically difficult for parents and physicians and the health care team than withholding therapy Withdrawing vs. Withholding Care Neonatology lacks the “holy grail” whereas an intervention/ approach to care will improve survival and decrease the prevalence of disability among survivors Annas GJ. NEJM 357:218, 2004

24. Ethical Dilemmas in the Delivery Room and on the NICU • Withdrawal versus withhold • Withhold - may prevent parental and physician anxiety, infant pain and suffering • Withdrawal - ethically, may be better since some may benefit from treatment in the delivery room • When to consider withdrawal? • Continuous re-evaluation on the NICU • Parents less likely to agree with physician recommendations for withdrawal • Examine infant - confirm findings • More defined risk of poor outcome(?), infant suffering

25. Delivery Room Resuscitation • Parents usually desire intervention to save the infant, irrespective of birth weight or condition at birth, as opposed to healthcare professionals • Most neonatologists initiate resuscitation and intensive care at 24 weeks with subsequent re-evaluation and decision making if deterioration or no improvement on the NICU—What additional information is learned? How much suffering will occur on the NICU? • Discussions/Decisions in the delivery room, in a crisis situation, are often difficult

26. To Withhold or Withdraw • Does not imply a child will receive no care • Signals a change in focus toward palliative or comfort care, making sure that the rest of the child’s life is as comfortable as possible • Ethically and legally, withholding and withdrawal of life-sustaining treatment are equivalent—but emotionally, they are sometimes poles apart

27. Death and Dying in the NICU1988-1998 19881998 Withholding or withdrawing interventions 25% (6%)* 46% (4%)* Active withdrawal - regardless of physiological stability 10% 42%† Moribund (futility) 7% 29% Stable (e.g., neurologic disorder, Trisomy 13, benefits>burden) 3% 13% DNR orders before CPR administered 36%† 85%† No CPR before death 16%† 69%†  More deaths in parents’ arms after extubation without CPR or epinephrine boluses  More Humane Approach to Care From Singh J, et al. Pediatrics 114:1620, 2004 *withholding care in the delivery room †p<0.001

28. Ethics and the NICU • What is success on the NICU to the delivering physician - good Apgars? • Neonatology success - discharge, survival for 28 days? • What is the definition of success for parents?

29. Ethics and the NICU • What is considered a “bad” or “unacceptable” outcome? Or a success? By whom? • Mental retardation (mild, moderate, severe) • Cerebral palsy (non-ambulatory, partly ambulatory) • Vision or hearing loss • Home ventilation • Later psychiatric disorders, behavioral disorders • Learning disabilities - special education • How high a risk of severe outcome is acceptable?

30. Whose Values are Most Important? In the case of very low birth weight babies, for example, different studies have interpreted the same facts differently... One study... assessed survivability as a good outcome, while other studies considered only survival without devastating neurological deficits to be a good result...Some physicians... claimed that even a 1% chance of survival, whatever the neurological devastation, was a good outcome. Many nurses, by contrast, felt that the pursuit of survival at all costs is unacceptable. Boyle PJ, Callahan D. Physician’s use of outcome data. In: Boyle PJ, ed. Getting Doctors to Listen. Washington, DC: Georgetown University Press, 1998

31. We have NO right to impose experimental therapies on newborn infants of 22 and 23 weeks’ gestational age in view of lack of data demonstrating effectiveness of care Ethics and the NICU Neonatology lacks the “holy grail” whereas an intervention/ approach to care will improve survival and decrease the prevalence of disability among survivors Vermont Oxford Network, 2004 Annual Meeting

32. Fetal Infants — 401-500 Grams Birth Weight • Admit ignorance - know little - bleak prognosis • Seek assistance from parents - treat vs. comfort care • Need follow-up data • NOT miracle babies - we are NOT miracle workers nor technological crazies Lucey JF. Pediatrics 113:1819, 2004

33. Infant with Down syndrome and duodenal atresia Death from starvation, dehydration at parents’ request A Forty-Year History of Ethical Dilemmas in the NICU 1963 Outcome 1973 • Physician allowed 43 infants to die over 30 months (multiple conditions) (Yale Series) • Parents and physician - joint decision making  “Imperiled newborns”

34. We need to convince our profession that its awesome technical power carries with it an equal responsibility to behave reasonably… If the Baby’s Not ‘Meaningful,” Kill It By George F. Will The Washington Post From Silverman WA. Pediatrics 98:1182, 1996

36. Baby Doe - trisomy 21 with TE fistula (Indiana); obstetrician: no therapy Pediatrician  court agreed with parents/OB physician to allow child to die without surgery A Forty-Year History of Ethical Dilemmas in the NICU 1984 Outcome • Baby Doe Regulations - to prevent discrimination against individuals with handicaps, and such individuals are to receive treatment without consideration of quality of life • All infants (excluding extremely premature infants and those with anencephaly) receive life-saving treatment without consideration of quality of life; exceptions: irreversible coma, futile and/or inhuman treatment

38. Physicians terminating treatment because of quality of life issues? Hotline - report non-treatment Signs Baby Doe Squads to conduct reviews State Child Protection Unit - “medical neglect” Ethics committees A Forty-Year History of Ethical Dilemmas in the NICU 1984 Outcome 1986 • Baby Jane Doe - myelomeningocele and hydrocephalus • Supreme Court upheld parents’ wishes not to treat

39. We need to convince our profession that its awesome technical power carries with it an equal responsibility to behave reasonably… Big Brother in the Nursery Gordon B. Avery. Star Tribune: April 13, 1983, p. 15A From Silverman WA. Pediatrics 98:1182, 1996

40. Are Neonatologists Out of Touch with Reality? …We find the scenarios (of neonatologists) for quality-of-life evaluations to be out of touch with the harsh realities of our children’s lives. Where is the description of the months or years of grueling hospitalization with the associated gastrostomy tubes, jejunostomy tubes, and fundoplications; the tracheostomies, shunts, and orthopedic, eye, and brain surgeries; hyperalimentation, oxygen tanks and ventilators? (continued)

41. Are Neonatologists Out of Touch with Reality? Similarly, there was no mention of bankruptcies, divorces, mental and physical breakdowns, death in late childhood, neglected siblings, and suicides caused by the extremeburdens of caring for severely medically and developmentally compromised children. Culver G, et al. JAMA. June 28, 2000

42. “David will be 9 on May 8. I consider this the ninth year of my jail sentence. Even killers get out on parole. Not the parents of micro-preemies, who suffer brain damage from being intubated, respirated, poked, prodded, bled and barely fed. Hospital gets $500 K from our private insurance. We get a life of broken dreams and sleepless nights.” Father of a micro-preemie

43. The Long Dying of Baby Andrew Robert & Peggy Stinson Atlantic Monthly Press Book, 1983

44. Child Abuse Amendments - 1984 • Direct federal intervention in NICUs ceased • States set up systems (preserve federal child abuse funds): Ensure all newborn children are protected against discrimination based on disability • Exceptions: Permanently comatose, near death or treatment is inhumane because futility • AMA, AAP: policies for treatment regardless of disability and quality of life • Initial results: less deferment to parental wishes Robertson JA. Neonatal Intensive Care 18:19, 2005

45. Child Abuse Amendments:When Treatment is NOT Mandated • Infant is dying — treatment willprolong the dying process • Infant is chronically and irreversibly comatose or unresponsive to the environment despite treatment • Treatment is futile, excessively burdensome and/or inhumane • Respect the intrinsicdignity and worth of the infant • Provide comfort, relieve pain and suffering

46. 23 wk, 615 g infant whose father refused to sign form permitting resuscitation Resuscitated and complex hospital course with severe sequelae at follow up Sued for battery and won ($64 million) but overturned on appeal Supreme Court: unable to evaluate for treatment until birth and may act in emergencies to prevent harm (outweigh harm from treatment) Not concerned with management on NICU A Forty-Year History of Ethical Dilemmas in the NICU 2000 Outcome

47. Miller Case—Potential Consequences of the Texas Supreme Court Ruling • Emergency circumstances exception • Maximal medical treatment for all infants - extend to other states • Not intended for everyone’s infant • Reversal of antepartum decisions and delivery planning for comfort care at 20-24 weeks’ gestation or if severe anomalies • Parents not allowed to deny life-sustaining treatment for child (“not allowed to let child die”)

48. Quality of Life and Withholding and Withdrawal of Support • American College of Obstetricians and Gynecologists* • 23-24 weeks’ gestation: initial management consistent with parental wishes • Fetus and Newborn Committee, Academy of Pediatrics† • Uncertain fetal prognosis, counseling may result in the family choosing not to actively intervene • Neonatologists, bioethicists • President’s Commission for the Study of Ethical Problems in Medicine - 1983 *Obstet Gynecol 100:617, 2002 †Pediatrics 110:1024, 2002

49. Physician’s assessment of treatment options Clearly beneficial* Ambiguous/uncertain Futile* Parents prefer to accept care Provide treatment Provide treatment Provide treatment unless provider declines Ethical Decision-Making Framework for the Management of Seriously Ill Newborn Infants Parents prefer to forego care Provide treatment during review process Forego treatment Forego treatment *Beneficial: Medical benefits of treatment outweigh risks Futile: Treatment that will not extend life or postpone death President’s Commission for the Study of Ethical Problems in Medicine. Washington, DC: Government Printing Office, 1983 In Peerzada JM, et al. J Pediatr 145:492, 2004

50. NICU Care • Technology has advanced much more rapidly in curing or at least palliating ill, often very premature, newborn infants than our ability to involve parents (and society) in ethical decision making, leading sometimes to prolonged suffering and painful and expensive NICU hospitalizations • This has led to drastic parental measures: father removing child from ventilation while holding caregivers at gunpoint (acquitted) or couple removing child from assisted ventilation after left alone (acquitted)