I have no financial relationships to disclose. I will not discuss off-label and/or

1. Disclosure InformationTheodore R. Thompson, M.D. I have no financial relationships to disclose. I will not discuss off-label and/or investigational use in my presentation.

2. Neonatal Ethics Theodore Thompson, M.D. Professor of Pediatrics Division of Neonatology University of Minnesota Medical School

3. Where I wish I was…

5. Ethics • Objectives – the ‘Gray Zone’ • To identify current ethical dilemmas in the newborn intensive care unit • To describe exceptions outlined in the Baby Doe rules – State Child Abuse amendments (1984) • To define the “gray zone” for viability in 2010 and outline what it means in discussions with parents • To describe involvement of parents and healthcare professionals in decision making for the type of care to provide to critically ill newborn infants or those at the limits of viability. • To describe two ways to help parents grieve the loss of their child.

6. Ethical Decisions on the NICU COMPLEX - Agonizing - Difficult - Unique – Humbling-Tragic • 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

7. Shared decision making 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

8. Ethical Decision Making on the NICU Caring Compassionate Communicative Competent Committed Healthcare Team

9. Definition of Prematurity *LBW: low birth weight-many preterm infants weigh more than 2500g VLBW: very low birth weight ELBW: extremely low birth weight

10. Patient Care • JG was a 700 gram (1 pound, 8 ounces) infant born at 24 weeks’ gestational age to a mother whose premature labor could not be stopped. The infant’s initial course was complicated by: • Severe respiratory syndrome requiring extensive ventilatory support (68 days); • Group B streptococcal sepsis • A patent ductus arteriosus requiring indomethacin therapy; • Grade 3 bilateral intraventricular hemorrhages with progressive hydrocephalus;

13. Patient Care The health care team offered the parents the following options: • Place a reservoir and continue with the current maximal intensive management • Place a reservoir and limit later therapy (e.g. no antibiotics for meningitis); • Do no further invasive procedures, but continue to provide comfort-palliative care with emphasis on pain relief

14. Ethical Issues/Areas in Perinatal-Neonatal Medicine • Limits of viability: 22-23-24(?) weeks’ gestation— GRAYZONE • Congenital anomalies • Prenatal • Fetal surgery • Postnatal - genetic, multiple anomalies, complex congenital heart disease (e.g. hypoplastic left heart syndrome) • Non- or slow responsiveness to therapy • Chronic lung disease (ventilator dependent) • Perinatal distress--severe • Intraventricular hemorrhage-severe • ECMO/Transplant-High Technology

15. Ethical Principles AUTONOMY – Individual’s Rights of Respect, Freedom and Liberty to make changes that affect one’s life. BENEFICENCE – Act so as to benefit others (Do good things) NON-MALEFICENCE – Do No Harm JUSTICE – Treat people truthfully, fairly Exception: life-threatening medical emergencies BEST INTERESTS OF THE INFANT

16. Ethical Dilemmas in Patient Care • Should we always resuscitate a 22-25 week gestational age infant against parental wishes? Should we always “doeverything” as requested by parents at 22, 23 or 24 weeks? • 25% chance of survival without disability at 25 weeks (12-15% at 24 weeks, 5-10% at 23 weeks) • What is in the Best Interests of the Infant • NICU care: 3-4 months, reduced maternal-paternal contact, painful procedures,infection, poor nutrition • Social influences: parents in 40s? Pregnancy- in vitro fertilization? One or both parents desire intervention? Unplanned pregnancy? Parents young and undecided and/or “do everything”?

17. Ethical Dilemmas on the NICU — Common Questions • Who should be involved in medical decisions of withholding/withdrawing or sustaining care for an infant? Parents Physician, Family members(which ones)? Nursing, Health Care Ethics Committees Professionals (e.g., social work, clergy) Courts?-NO Federal or State legislature?-NO

18. Ethical Dilemmas on the NICU — Common Questions • What do you do if the parents’ wishes regarding their child’s care differ from yours and from the accepted or standard medical care — the parents want “full support” or want “no resuscitation,” which is different from accepted standard of medical care?

19. Ethical Dilemmas on 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? • Should the infant’s long-term prognosis (qualityof life) affect decision making?

20. Ethical Dilemmas on the NICU — Common Questions • 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 with physician review in the Netherlands)

21. Ethical Dilemmas on the NICU — Common Questions • Should resource allocation (finances, beds, staffing) or psychosocial issues (e.g., breakup of a marriage) be part of the medical decision?

22. Ethics Issues on 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

23. Berger, TM. J. Pediatr 2010;156:  7 (January). 

24. Ethics in the NICU Parental decisions will be influenced by their love for their newborn infant. Therefore, one can almost always rely on the parents’ decisions to be in the best interest of their infant. The physician and health care team must assess if the proposed management is in the best interest of the infant. CONSENSUS between Parents, Health Care Team

25. Patient Care-JG The mother felt she could care for an infant-child with significant disabilities (the father said very little except to continue current management): • Cerebral palsy • Cognitive delay • Visual and hearing impairment

26. Patient Care-JG The mother expressed sincere concern about whether it was fair to the child to be subjected to suffering, pain and a poor quality of life. She wanted to act in the “best interest” of her child.

27. Baby Doe – infant with trisomy 21 and TE fistula (Indiana); obstetrician: no therapy Pediatrician  court agreed with parents/OB physician to allow child to die without surgery Over 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

29. 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

31. 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

32. 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” Hospital Ethics Committees Over 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

33. 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

34. Withdrawal of Nutrition and Fluids from Children • Nutritional support (feeding and hydration—mine) can ethically be withdrawn or withheld from certain children with terminalillnesses or with severe, irreversible disabilities—Bioethics Committee, American Academy of Pediatrics: • “Medically provided fluids and nutrition may be withdrawn from a child who permanently lacks awareness and the ability to interact with the environment” or “in cases of terminal illness when nutritional support only prolongs and adds morbidity to the process of dying” or “in nonterminal illnesses that cause intense, inexorable, discontent”. Balance: Burdens/Benefits Diekema, D., Botkin, JR Pediatrics 2009; 124: 813-22 (Amer Acad Pediatrics, Committee on Bioethics)

35. Withdrawal of Nutrition and Fluids from Children (Continued) • Categories of illness where withdrawal of nutrition and fluids may be CONSIDERED (burdens may outweigh benefits of the intervention), but never morally or ethically required: • Persistent vegetative state (CNS injury, disease present) • Minimally conscious state (?) • Severe CNS malformations (e.g. anencephaly, massive intraventricular hemorrhage) • Terminal illness associated with significant pain despite palliative treatment • Severe gastrointestinal, renal, or cardiovascular disease/malformation with intestinal/renal/cardiac failure • PARENTS MUST BE INVOLVED IN THE DECISION MAKING PROCESS Diekema, D., Botkin, JR Pediatrics 2009; 124: 813-22 (Amer Acad Pediatrics, Committee on Bioethics)

36. Withdrawal of Nutrition and Fluids from Children(Continued) • Balance Burdens and Benefits • Always act in the best interest of the child • Always act with Shared Decision Making with the parents/guardians • Always consider/obtain ethics consultation before final decision Diekema, D., Botkin, JR Pediatrics 2009; 124: 813-22 (Amer Acad Pediatrics, Committee on Bioethics)

37. Attitudes Toward Limiting Life Sustaining Treatments Clinical Scenario 4:This full-term male infant has suffered hypoxic ischemic encephalopathy (HIE) after a maternal uterine rupture. His umbilical artery cord pH was 6.7 with a PCO2 of 90 and bicarbonate(HCO3) of 12. He was immediately transferred after birth to a NICU where total body cooling (hypothermia) was undertaken for 3 days. At two weeks of age, burst suppression on the EEG was still present and he had few spontaneous movements. There were minimal sucking-gag reflexes. He required gavage feedings.

38. Clinical Scenario 4 (continued)In preparation for the meeting with the family, what options would you consider? Modified from Feltman, D and Leuthner, S. AAP Perinatal Section Survey. 2010

40. 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 • Continuous re-evaluation on the NICU • When to consider withdrawal? • Parents less likely to agree with physician recommendations for withdrawal • Examine infant - confirm findings, follow clinical course • More defined risk of poor outcome(?), infant suffering

41. 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

42. To Withhold or Withdraw… • Does NOT imply a child will receive no care—care may actually increase • Signals a change in focus or type of care topalliative 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

43. Success on 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?

44. 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?

45. 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

46. NICU Care • Technology has advanced much more rapidly in curing or at least palliating extremely premature, critically ill 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) • Family centered care has dramatically reduced these issues

48. Bald Park Figure The All No-Hair-to-Spare Team

49. Choosing a Gray Zone 23 0/7 – 24 6/7 weeks gestation (500-600 grams) Rationale: • Rapid increase in survival from below 20% to 60-70% • Decrease in incidence of severe ROP, Chronic lung disease +/-, severe cranial ultrasound abnormalities (IVH, PVL, hydrocephalus) • Overall “intact” survival increases from <5% to about 40% • Outcome still very uncertain for individual patients