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

University of Minnesota Amplatz Children’s Hospital

I have no financial relationships to disclose.

I will not discuss off-label and/or investigational use in my presentation.

Disclosure InformationTheodore R. Thompson, M.D.


Neonatal Ethics

Neonatal EthicsTheodore Thompson, M.D.

Professor of PediatricsDivision of Neonatology

University of Minnesota Medical School


Where I wish I was…


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.


Ethical Decisions on the NICU

• 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

COMPLEX - Agonizing - Difficult - Unique – COMPLEX - Agonizing - Difficult - Unique – Humbling-TragicHumbling-Tragic

NEVER, EVER gets any easierNEVER, EVER gets any easier


Neonatology lacks the “holy grail” whereas an intervention/ approach to care will improve survival and decrease the prevalence of disability among survivors

Shared decision making to limit or withdraw treatment: parents in collaboration-collaboration-

partnershippartnership with physician, nursing and health care professional staff, all acting in the

best interests of the infant

Support: family, friends, clergy,support group, others

Shared decision making to limit or withdraw treatment: parents in collaboration-collaboration-

partnershippartnership 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


Ethical Decision Making on the NICU

Caring

Compassionate

Communicative

Competent

Committed

Healthcare Team


Definition of PrematurityWeeks

Preterm Births (%)

Birth Weight (gm)

Preterm < 37 100< 2500 (LBW)*

Late preterm 34 0/7-36 6/7 75 <2500-3500

Very preterm < 32-33 20< 1500 (VLBW)

Extremely preterm

< 28 10< 1000 (ELBW)

Micropremie or fetal infant

< 26 1-2 < 750

*LBW: low birth weight-many preterm infants weigh more than 2500g VLBW: very low birth weight ELBW: extremely low birth weight


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;


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


Ethical Issues/Areas in Perinatal-Neonatal Medicine

• Limits of viability: 22-23-24(?) weeks’ gestation—GRAY ZONE

• 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


Ethical PrinciplesAUTONOMY – 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


Ethical Dilemmas in Patient Care• Should we always resuscitate a 22-25 week

gestational age infant against parental wishes? Should we always “do everything” 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”?


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



• 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?



• 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 (quality of life) affect decision making?



• 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)



• Should resource allocation (finances, beds, staffing) or psychosocial issues (e.g., breakup of a marriage) be part of the medical decision?


Ethics Issues on the NICU• Health care decisions must reflect the

“best interestsbest interests” of the infant

“Best InterestsBest 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


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


Ethics in the NICUParental 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


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


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.


Over Forty-Year History of Ethical Dilemmas in the NICU

• 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

• 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

1984 Outcome


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

If the Baby’s Not If the Baby’s Not ‘Meaningful,” Kill It‘Meaningful,” Kill It

By George F. Will

The Washington Post

If the Baby’s Not If the Baby’s Not ‘Meaningful,” Kill It‘Meaningful,” Kill It

By George F. Will

The Washington Post




reasonably…


Big Brother Big Brother

in the Nurseryin the Nursery

Big Brother Big Brother

in the Nurseryin the Nursery

Gordon B. Avery. Star Tribune: April 13, 1983, p. 15A


Over Forty-Year History of Ethical Dilemmas in the NICU

• 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

1986• Baby Jane Doe -

myelomeningocele and hydrocephalus

• Supreme Court upheld parents’ wishes not to treat

1984 Outcome


Child Abuse Amendments:When Treatment is NOT Mandated• Infant is dying — treatment will prolong 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 intrinsic dignity and worth of the infant

– Provide comfort, relieve pain and suffering


Withdrawal of Nutrition and Fluids from Children

• Nutritional support (feeding and hydration—mine) can ethically be withdrawn or withheld from certain children with terminal illnesses 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/BenefitsDiekema, D., Botkin, JR Pediatrics 2009; 124: 813-22(Amer Acad Pediatrics, Committee on Bioethics)


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

PROCESSDiekema, D., Botkin, JR Pediatrics 2009; 124: 813-22(Amer Acad Pediatrics, Committee on Bioethics)


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)


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.


I would refuse this option

I would agree to this option at the parents request

I would offer this option to the parents

I would recommend this

option to the parents with support

I would strongly recommend this option to the parents with support

Non-escalation of care

Do not resuscitate order

Discontinuation of mechanical ventilation

Discontinuation of TPN-IV hydration

Discontinuation of inotropic agents

Discontinuation of enteral feedings

Transfer to home hospice

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


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



Withholding - omit a form of treatment not considered beneficial

Withdrawal - remove treatment that has not achieved beneficial intent or is ineffective

Withholding - omit a form of treatment not considered beneficial

Withdrawal - remove treatment that has not achieved beneficial intent or is ineffective

Ethics and the NICUEthics and the NICU

Equal from a moral, legal perspectiveEqual from a moral, legal perspective


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 to 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


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 parentsparents?


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?


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


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


Bald Park FigureBald Park FigureThe All No-Hair-to-Spare TeamThe All No-Hair-to-Spare Team


Choosing a Gray Zone

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

23 0/7 – 24 6/7 weeks gestation (500-600 grams)


The Long Dying of Baby AndrewThe Long Dying of Baby Andrew

Robert & Peggy Stinson

Atlantic Monthly Press Book, 1983

The Long Dying of Baby AndrewThe Long Dying of Baby Andrew

Robert & Peggy Stinson

Atlantic Monthly Press Book, 1983


• 1960s: 30-31 weeks• 1980s: 27-28 weeks• 1990s: 24 weeks• 2000: 23-24 weeks

– Intrapartum monitoring– Cesarean section, Ultrasound– Antenatal steroids– Resuscitation-intubation (heart rate present)– NICU - surfactant– Ventilatory support - less barotrauma

50% Survival Rate For Newborn Infants


Survival Rates For Extremely Premature Infants

WEEKS SURVIVAL

22 0-5%

23 25-40%

24 50%

25 60-75%

26 75-90%

27-28 95%


Survival Rates of Liveborn Newborn Infants in the 1990s —

22-26 weeksGestational Age n Mean (%) Range (%)

22 186 13 0-21

23 521 30 7-46

24 1325 57 17-68 (>50)

25 3297 79 53-82

26 1716 82 67-93

Lorenz J. Semin Perinatol 8:475, 2003


Survival and Morbidity Rates for Extremely Premature Infants Sweden 2004-2007

Gestational Age Live Born+ NICU Admissions*(Weeks) Number Overall One One Year One year

survival Year Survival (%) Number Survival-% Number without major morbidity (%)

≤22 51 10% 19 26% 1 20% (2%)

23 101 53% 81 65% 9 17% (9%)

24 144 67% 132 73% 30 31% (21%)

25 205 82% 200 84% 75 45% (37%)

26 206 85% 204 86% 111 63% (54%)

TOTAL <27 707 70% 636 78% 226 45% (32%)

*90% of live born infants admitted to the NICUcMorbidity-grade 3 or 4 intraventricular hemorrhage; >stage 2 retinopathy; cystic periventricular leukomalacia; necrotizingenterocolitis; and/or severe bronchopulmonary dysplasia (>30% oxygen at 36 weeks PMA)+Percent (%)-live born infants without major neurologic morbidity at one yearNote: 40% of the 104 deaths after 24 hours on the NICU relate to change in focus to comfort care

Modified from: The EXPRESS GROUP, JAMA 2009; 301: 2225


Survival Rate to Hospital Discharge of Extremely Low Birth Weight Infants (<1000

grams) (Mid 1990s-2003)

Gestational Age (Weeks) Survival Rate+

(USA, Finland, Sweden, UK, France)

22 0-5%

23* 11-43%

24 26-61%

25* 44-77%

*ACOS-111 days at 25 weeks, about 210 days at 23 weeks+Higher rate in later years

Yearney,NK et al, BMJ 2009, 339: 100


Survival Rates of Extremely Premature Infants Admitted to the NICU-UMACH and

Vermont-OxfordGestational Age UMCH, Fairview (2009) Vermont Oxford (2008)*

(weeks) Number Rate Number Rate

22 2 0% 327 7%

23 2 50% 841 35%

24 11 52% 1282 59%

25 5 73% 78% 1427 74% 72%

26 21 91% 1670 81%

27 17 94% 1935 89%

* First 3 quarters

50% 27%


Survival Rates by Gestational Age of Ultrapremature (Fetal Infants, Micropremies)

Infants in Japan, 2002-04

Gestational Survival Rate Neurological Sequelae Age 1995-2001 2002-04 2002-04

22 Weeks 18% 31%* 36%(51/164)

23 Weeks 40% 56%* 32%(234/416)

Ikeda, K. etal, NeoReview 7:e511, 2006

*Outcome (survival) improves day by day from 22 weeks plus 0 day to 23 weeks plus 6 days

Factors: Active intervention, prenatal steroids, High Frequency Ventilation, Postnatal steroids(?), surfactant, OB/neonatal care


Overall Disability At 30 Months For Infants Overall Disability At 30 Months For Infants Born At 22 - 25 Weeks Gestational AgeBorn At 22 - 25 Weeks Gestational Age

Other disability(25%)

No disability(49%)

Severe disability(23%)

Died(2%)

No data(1%)

Wood NS, et al. NEJM 343:378, 2000Wood NS, et al. NEJM 343:378, 2000

nn = 314 children = 314 children


Survival of Extremely Immature Infants Without Profound

Impairment

Survival

0 10 20 30 40

Male

Female

Male

Female

Male

Female

Observed

Maximum Potential

400-500 g

22 Weeks

501-600 g

23 Weeks

601-700 g

24 Weeks

Tyson, JE et alNEJM 358:1672, 2008


Bottom Line: Best Survival Estimate

23 weeks – 20%

24 weeks – 50%

25 weeks – 65%

26 weeks – 80%


Bottom Line: Best Intact Survival Estimate

23 weeks: <5%

24 weeks: 10-20%

25 weeks: 30-40%

26 weeks: 50-65%


Reported Outcomes for Very Preterm Survivors (<26 weeks, <1000 grams)

Vs Full Term Infants(1990s-2005) Outcome Very Preterm Full Term

Neurodevelopmental Morbidity 25% 4%

Cerebral Palsy 10% 0.1-0.2%

School Difficulties 75% 12%

Behavioral Disorders Much Higher Risk —

Hospital Readmissions (Respiratory) 2-3 fold ↑ —

Visual Difficulties (Glasses) 26-36% 4-10%

Severe Hearing Impairment 5-7% 1%

Growth Lighter, Shorter? --HealthCare-

Quality of Life Similar — Doyle LW, Saigal S NeoReviews 2009;10: e130


Limits of Viability: 2010

• 23 weeks’ gestation

• 400-450 grams birth weight (appropriate growth)




reasonably…


The Limits of Viability:Decision Tree

Unreasonable Mandatory

<23 weeksGray Zone

23-246/7 wk &500-600 g

Comfort care only Full critical care

≥25 weeks

Parents indicate definite wishes for non-active intervention

(Importance of counseling regarding impact of initial condition/perinatal stress on outcome)

Parents desire active intervention or defer to medical judgment

Follow parents’ wishes unless evidence parents not working in best

interest of the baby

Extent of active intervention based on condition and response -

constant reevaluation


Ethical Dilemmas at the Limits of Viability

• Provide parents with survival and follow-up statistics for the specific NICU; nationwide (?)

• Determine wishes of parents if possible: comfort care vs. resuscitation

• Assure parents the team will abide by their wishes (within reason) and will avoid desperate heroics and callous disregard– May need to be modified (sometimes extensively) after

birth if new and more accurate information becomes manifest regarding gestational age and prognosis



A major frustration and difficulty in neonatal-perinatal medicine

is the inability to accurately predict an individual infant’s

prognosis

A major frustration and difficulty in neonatal-perinatal medicine

is the inability to accurately predict an individual infant’s

prognosis


Estimates of Benefit [Survival, With and Without Moderate to Severe and Profound Impairment] of

Neonatal ICU Care (1998-2003) 18-22 Months Postmenstrual Age

www.nichd.nih.gov/neonatalestimates

(Gestational Age, Birthweight (grams), Sex, Singleton/Multiple, Antenatal Steroids)

Tyson, JEetalNEJM 358:1672, 2008


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


Neonatal Intensive CareHighly Stressed Environment—Highly Charged

Situations

Tripp, J & McGregor, D. Arch Dis Child Fetal & Neonatal Ed. 91:f67, 2006

The Gray Zone

Prognosis for severe handicap/death

YES

NONORMAL CERTAIN

With

hold

or w

ithdr

aw

trea

tmen

t


Care of the Extremely Premature Infant — 450-600 Grams, 22-24

weeks• Leads care-giving team, parents into zone of

ambiguity or the “GRAY ZONE”

• Choice often between greater and lesser goods and harms in the “GRAY ZONE” - not “right” and “wrong”

• People of good faith will proceed differently in good conscience, making different decisions


Imperfect Outcomes of NICU Care

• Three Facts:

– Some families experience a lifetime of tragedy and suffering with prolongation of life

– Many “imperfect lives” have significant value

– A very few infants may die who could have survived with additional extensive care and some suffering.


Ethical Decision-Making on the NICU

Parents plus Physicians, Nurses

RelativesClergy Other Support People

Neonatal Ethics Committee

Resolution Child Protective Agency

Court


Decisions

• Decisions should be made in the patient’s best interests with the health care team

• Decisions should be made by the family with the health care team

• Decisions should be thoughtfully made with the best possible information

• Decisions should be reviewed to ensure adherence to the principles of non-maleficence, autonomy, beneficence, justice/equity


Consideration of Withdrawal or Change in Care

• The outcome for a clinical problem at the time of presentation is uncertain

• The team must wait until enough information (not feelings)…enable a clear decision on possible withdrawal

• It is sufficient to have a reasonable belief that a particular outcome is likely and that absolute certainty may be neither possible nor always necessary


Attitudes Toward Limiting Life Sustaining Treatments

Clinical Scenario 1: You are involved in the care of a 2 week old male infant born at 23 weeks’ gestational age who has worsening respiratory status with marked, bilateral pulmonary interstitial emphysema (or bilateral grade III-IV intraventricular hemorrhages) on chest x-ray. You have treated the infant with high frequency oscillatory ventilation, inhaled nitric oxide and steroids. The baby’s oxygen saturation levels are in the 40-60% range during the past 24 hours.


I would refuse this option

I would agree to this option at the parents request

I would offer this option to the parents

I would recommend this option to the parents with support

I would strongly recommend this option to the parents with support

Non-escalation of care

Do not resuscitate order

Discontinuation of mechanical ventilation

Discontinuation of TPN-IV hydration

Discontinuation of inotropic agents- dopamine/dobutamine/epinephrine-

Clinical Scenario 1 (continued)

What options would you select in your discussion with the parents of this infant:

Modified from Feltman, D and Leuthner, S. AAP Perinatal Section Survey. 2010



Knowledge of the range of ethically supportable and acceptable options must be understood and shared with the family decision maker(s) and the professional must be

prepared to support the choice of the family. The choice, often in the gray zone, may not be our choice for our own child (most professionals have not had to make such difficult choices confronting the families with whom we are working).

Knowledge of the range of ethically supportable and acceptable options must be understood and shared with the family decision maker(s) and the professional must be

prepared to support the choice of the family. The choice, often in the gray zone, may not be our choice for our own child (most professionals have not had to make such difficult choices confronting the families with whom we are working).

Ethics and the NICUEthics and the NICU

Hartline JV. J Perinatol 21:248, 2001


Estimates of Benefit [Survival, With and Without Moderate to Severe and Profound Impairment] of

Neonatal ICU Care (1998-2003) 18-22 Months Postmenstrual Age

www.nichd.nih.gov/neonatalestimates

(Gestational Age, Birthweight (grams), Sex, Singleton/Multiple, Antenatal Steroids)

Tyson, JEetalNEJM 358:1672, 2008


Withdrawal of Neonatal Life Support — Limitations of

Resuscitative Efforts

• Decisions - parents, health care professionals

– Complex

– Stressful

– Tragic


“Sorry I’m late, but they had me on life support for two months.”


We are NOTNOT

the placenta

We are NOTNOT

the placenta


Parents and the NICUSources of Stress

• Maternal ill health

• Separation from her infant

• Strange, “hostile” environment - ALIEN ALIEN environmentenvironment

– High-tech noise, light

• Unfamiliar staff

• Complex medical disorders to understand

– Note: Post-traumatic stress disorder

Fowlie PW, McHaffie H. BMJ 329:1336, 2004


Parents and the NICUSources of Stress

• Appearance, condition of infant - tubes, wires, other

• Sudden unexpected changes — two steps forward, one step back—Rollercoaster ride

• LACK OF CONTROL, UNCERTAINTYLACK OF CONTROL, UNCERTAINTY

• Lack of information

• Financial hardshipFowlie PW, McHaffie H. BMJ 329:1336, 2004


Death on the NICU

• A desperate time for affected families

• Involve Parents in the Decision Making — Involve Parents in the Decision Making — they want to be involved-Shared they want to be involved-Shared Decision Decision MakingMaking

• Parents need full, open, honest communication, given in a compassionate fashion, by experienced staff who know their baby and them

Fowlie PW, McHaffie H. BMJ 329:1336, 2004


Neonatal Intensive Care Unit

Videotape for parents, staff: Colorado Trust, Colorado

Collective for Medical Decisions and Nickel’s Worth

Productions, 1998, Denver, Colorado

You Are Not AloneYou Are Not Alone

Hulac P. J Clin Ethics 12:251, [email protected]


Withholding/Withdrawing Life-Sustaining Treatment in the NICU

• Open, informed and COLLABORATIVE process between parents and healthcare team leads to the best decisions in the most comfortable manner

• Physicians may need to provide a recommendation with a consensual decision-making process undertaken with the parents

• Parental involvement in end-of-life decision Parental involvement in end-of-life decision making appears to ameliorate the subsequent making appears to ameliorate the subsequent grieving process and does not increase their grief, grieving process and does not increase their grief, interfere with mourning or burden them with guiltinterfere with mourning or burden them with guilt


The Delivery of Bad Medical News

• How information is delivered and how well staff is trusted will affect decision making– Provide a private place for the conversation

– Provide information in a compassionate manner

– Allow yourself to feel the tragedy-humility, empathy

– Include information about the positive characteristics of the child

– Let parents know of bad news as soon as it is suspected (chromosomes drawn)


The Delivery of Bad Medical News

• Have the information come from someone who the parents trust, who is familiar with them and who knows their infant

• Give the information in a stepwise fashion and pace the information; allow for opportunities to ask questions

• Arrange to have support persons present

• Avoid discussion about “taking things away” — present as a shift to comfort care and “allow natural death”

• Caring and support are NOTNOT “withdrawn”—shifted, NOT removed


Success of Family Centered Neonatal Care

• Family centered neonatal care should be based on OPEN and HONEST COMMUNICATION between parents and health care professionals on medical and ethical issues to form the foundation of TRUST essential for optimal patient care

Izatt, S., NeoReviews (2008) 8: e321


Suggestions to Help Families Grieve• DO

– I am sorry for your pain or your loss– Be Honest- “how do you (parents) understand the

situation”– Keep appointments—contact parents on time– Be compassionate, caring, humble, empathetic– LISTEN-Be Quiet

• Let families express their feelings• OK to say, “I do not know-- I will find out the answer.”

Marron-Corwin, M.J., Corwin, DD

NeoReviews (2008) 8: e348


Suggestions to Help Families Grieve (Continued)

• DO– Keep in contact with parents

• Thinking of them

– Grief is hard work—be kind, patient with loved ones

– Explore spiritual aspects with parents– Encourage closure: holding, speaking to

fetus/infant at precious moments, take photos, take memory box home, plan a memorial service

Marron-Corwin, M.J., Corwin, DDNeoReviews (2008) 8: e348


Quality of Palliative Care —Painful Isolated Incidents

• One of the most striking findings was how a single event could cause parents profound and lasting emotional distress:

– Insensitive or rushed delivery of bad news

– Perceived disregard for parents’ judgment about care of their child

– Inflexibility

– Poor communication of important information



NICU

Sophisticated, intensive care environment with aggressive interventions

In combination with

Patient/family-centered comfort and palliative care

Ethical issues are emotionally, physically and intellectually demanding

NICU

Sophisticated, intensive care environment with aggressive interventions

In combination with

Patient/family-centered comfort and palliative care

Ethical issues are emotionally, physically and intellectually demanding

High-tech — high touchHigh-tech — high touch


Neonatal Ethics




reasonably…


The Limits of Viability:Decision Tree

Unreasonable Mandatory

<23 weeksGray Zone

23-246/7 wk &500-600 g

Comfort care only Full critical care

≥25 weeks

Parents indicate definite wishes for non-active intervention

(Importance of counseling regarding impact of initial condition/perinatal stress on outcome)

Parents desire active intervention or defer to medical judgment

Follow parents’ wishes unless evidence parents not working in best

interest of the baby

Extent of active intervention based on condition and response -

constant reevaluation



• Ongoing– How low is low enough?

• Do we go below 23 weeks—note Japan?

– Which morbidities most severely affect quality of life? Which are “worse than death”?

– What are best prognostic indicators of later developmental handicaps?

• Seizures• Surgery for necrotizing enterocolitis• Chronic lung disease• V-P shunt for hydrocephalus• Other

– What is the meaning of “in the best interests of the child”?


Remember: NICU Ethical Issues• These are guidelines, not absolute formulae; care

must be individualized for each clinical circumstance

• Prognosis can change rapidly. At birth and at each stage of resuscitation, the likelihood for reasonable outcome should be reevaluated

• This approach assumes adequate antenatal counseling

• Parental wishes regarding extent of intervention in the gray zone should almost always be honored depending on the infant’s condition and correct gestational age


NICU CareNICU Care

Often confronted by moral

dilemmas to which there are NONO

easy answers and about which

reasonable people disagree

NICU CareNICU Care

Often confronted by moral

dilemmas to which there are NONO

easy answers and about which

reasonable people disagree


“Common Sense Is Not So Common” (What we all Need to Remember)

– Admission to an intensive care unit in a tertiary hospital can be a harrowing experience for the patient (and the family-mine).

• …it is IMPERATIVE that we periodically step back from the bedside and decide what are our goals. Is there a REASONABLE CHANCE that all that is being done will result in meaningful survival? If the answer is “NO” or “PROBABLY NOT”, then the time has come to start discussing plans with the family to DISCONTINUE SUPPORT.

Alpert, JS Amer J Med

2009; 122: 789-790



The late 21st century is marked by a much more democratic participatory process of health care decision making—patients-parents are taking a much more active and participatory role in decision making based on their values and beliefs. In neonatal-perinatal medicine, parents are responsible for health care decisions and desire to be part of the decision-making process with dramatically diminished acceptance of medical parentalism. The most optimal outcomes result from consensual or shared The most optimal outcomes result from consensual or shared

decision making, involving both the parents and the physicians-decision making, involving both the parents and the physicians-

health care team, that respects parental authority and promotes health care team, that respects parental authority and promotes

physicians “doing no harm” and acts in the best interests of the physicians “doing no harm” and acts in the best interests of the

infant.infant.

The late 21st century is marked by a much more democratic participatory process of health care decision making—patients-parents are taking a much more active and participatory role in decision making based on their values and beliefs. In neonatal-perinatal medicine, parents are responsible for health care decisions and desire to be part of the decision-making process with dramatically diminished acceptance of medical parentalism. The most optimal outcomes result from consensual or shared The most optimal outcomes result from consensual or shared

decision making, involving both the parents and the physicians-decision making, involving both the parents and the physicians-

health care team, that respects parental authority and promotes health care team, that respects parental authority and promotes

physicians “doing no harm” and acts in the best interests of the physicians “doing no harm” and acts in the best interests of the

infant.infant.

Ethical Issues on the NICUEthical Issues on the NICU


Neonatal Ethics

The tremendous advances over the past three decades must NOT blind us to human dignity. There is a bottom line, often a Gray Zone, we enter unknowingly because it is not clearly demarcated, below which human existence loses its dignity. We, as health care professionals, struggle with decisions to continue or forego treatment in this Gray Zone.

Our responsibility is not only to be a good technician, but also a caring, concerned, competent, compassionate, and committed physician (health care professional-mine).

Modified from Hazebroek, FW. J. Pediatr Surg 41:18, 2006


Ethical PrinciplesAUTONOMY – 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



• 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

COMPLEX - Agonizing - Difficult - Unique – COMPLEX - Agonizing - Difficult - Unique – Humbling-TragicHumbling-Tragic

NEVER, EVER gets any easierNEVER, EVER gets any easier


• Faith’s Lodge– www.faithslodge.org

• Now I Lay Me Down to Sleep– http://www.nowilaymedowntosleep.org


Ethics on the NICU

Many extremely premature

infants who survive the neonatal

period will live healthy and

fulfilling lives


ReferencesNeonatal Morbidity and Mortality at the Limits of Viability-Outcomes*Carter BS. How can we say to neonatal intensive care parents among crisis, ‘you are not

alone’? Pediatrics 2002; 110: 1245.Colvin M, McGuire W, Fowlie PW. ABC’s of preterm birth: Neurodevelopmental outcomes

after preterm birth. Br Med J 2004; 329: 1390.*Doyle LW, Saigal S. Long-term outcomes of very preterm or tiny infants. NeoReviews 2009;

10: e130. Fine RL et al. Medical futility in neonatal intensive care unit: Hope for a resolution. Pediatrics

2005; 116: 1219.*Higgins RD et al. Executive summary of the workshop on the border of viability. Pediatrics

2005; 115: 1392.*Ikeda K et al. Recent short term outcomes of ultra preterm and extremely low-birth weight

infants in Japan. NeoReviews 2006; 7: e511. *Lucey JF, Rowan CA, Shiono P, et al. Fetal infants: the fate of 4,172 infants with birth

weights of 401 to 500 grams-the Vermont Oxford Network experience (1996-2000). Pediatrics 2004; 113: 1559.

*Marlow N, Wolke D, Bracewell MA, et al. Neurologic and developmental disability at 6 years of age after extremely preterm birth. NEJM 2005; 352: 9.

O’Shea M ed. Neonatal outcomes. Semin Perinatol 2008; 32: 1*Peerzada JM, Richardson DK, Burns JP. Delivery room decision-making at the threshold of

viability. J Pediatr 2004; 145: 492.*Tyson JE et al. Intensive care for extreme prematurity-moving beyond gestational age.

NEJM 2008; 358: 1672.*Vohr BR, Allen M. Extreme prematurity- the continuing dilemma. NEJM 2005; 352: 71.*Yeaney NK et al. The extremely premature neonate: Anticipating and managing care. BMJ

2009; 339: 100.


References (continued)General-EthicsBoyle RJ. Ethical issues in the care of neonates. NeoReviews 2004; 5(11): e471.*Committee on Fetus and Newborn. Clinical report—antenatal counseling regarding resuscitation and extremely low

gestational age. Pediatrics 2009; 124: 422.*Committee on Fetus and Newborn. Noninitiation or withdrawal of intensive care for high-risk newborns. Pediatrics

2007; 119: 401.Janvier A, Barrington KJ. The ethics of neonatal resuscitation at the margins of viability: Informed consent options. J

Pediatrics 2005; 147: 579.*Kaempf JW et al. Medical staff guidelines for periviability pregnancy counseling and medical treatment of extremely

premature infants. Pediatrics 2006; 117: 22.Kuebelbeck A. Waiting With Gabriel. Loyola Press: Chicago 2003.*Lantos JD. The Lazarus Case: Life and Death Issues in Neonatal Intensive Care. Johns Hopkins Press: Baltimore

2001.Lorenz JM. Ethical dilemmas in the care of the most premature infants: The waters are murkier than ever. Curr Opin

Pediatr 2005; 17: 186.McGraw MP, Pearlman JM. Attitudes of neonatologists towards delivery room management of confirmed Trisomy 18:

Potential factors influencing a changing dynamic. Pediatrics 2008; 121: 1106.Merialdi M, Murray JC. The changing face of preterm birth. Pediatrics 2007; 120: 1133.*Nuffield Council on Bioethics. Critical care decisions in fetal and neonatal medicine: Ethical issues. November 2006. *Partridge J, Dickey BJ. Decision-making in neonatal intensive care: Interventions on behalf of preterm infants.

NeoReviews 2008; 10: e270.*Pignotti MS, Donzelli G. Perinatal care at the threshold of viability and an international comparison of practical

guidelines for the treatment of extremely preterm births. Pediatrics 2008; 121: e193.*Singh J et al. Resuscitaton in the “gray zone” of viability: Determining physician preferences and predicting infant

outcomes. Pediatrics’ 2007; 120: 519.Stinson R, Stinson P. The Long Dying of Baby Andrew. Atlanta Monthly Press Book 1983.Tripp JN, McGregor D. Withholding and withdrawing of life-sustaining treatment in the newborn. Arch Dis Child Fetal

Neonatal 2006; 91: F67.Weiss AR et al. Decision-making in the delivery room: A survey of neonatologists. Journal of Perinatology 2007; 27:

754.


References (continued)

Communication• *Hayward MF et al. Message framing and perinatal decisions. Pediatrics 2008; 122:

109.• *Izatt S. Difficult conversations in the neonatal intensive care unit. NeoReviews

2008; 9: e321.• *Kon AA. Answering the question: “Doctor, if this were your child, what would you

do”. Pediatrics 2006; 118: 393.• *Pantilat SZ. Communicating with seriously ill patients: Better words to say. JAMA

2009; 301: 1279.• Quill TE et al. Discussing treatment preferences with patients who want “everything”.

Ann Intern Med 2009; 151: 345.• *Reder EAK, Serwint JR. Until the last breath: Exploring the concept of hope for

parents and health care professionals during a child’s serious illness. Arch Pediatr Adolesc Med 2009 163: 653.

• *Zimmermann NE, Sprague EJ. The NICU Rollercoaster. Xlibris Corporation (1-888-795-4274, [email protected]) 2008.


References (continued)

Palliative Care • *Bhatia J. Palliative care in the fetus and newborn. J Perinatology 2006; 26, S24.• *Brosig CL et al. End of life care: the parents’ perspective. J Perinatology 2007; 27:

510.• *Caitlin A, Carter B. Creation of a neonatal end-of-life palliative care protocol. J

Perinatol 2002; 22: 184. • Carter BS. Comfort care principles for the high-risk newborn. NeoReviews 2004;

5(11): e484.• Contro NA, Larson J, Scofield S, et al. Hospital staff and family perspectives

regarding quality of pediatric palliative care. Pediatrics 2004; 114: 1248.• *Diekema DS, Botkin JR. Clinical report-foregoing medically provided nutrition

hydration for children. Pediatrics 2009; 124: 813 (Committee on Bioethics).• *Feudtner, C et al. Hopeful thinking and level of comfort regarding providing pediatric

palliative care: A survey of hospital nurses. Pediatrics 2007; 119: e186.• *Marron-Corwin MJ, Corwin AP. When tenderness should replace technology: The

role of perinatal hospice. NeoReviews 2008; 9: e348.• Munson D. Withdrawal of mechanical ventilation in pediatric and neonatal intensive

care units. Pediatr Clin N. Am. 2007; 54: 773.


References (continued)Legal• *Annas GJ. Extremely preterm birth and parental authority to refuse treatment-the

case of Sidney Miller. NEJM 2004; 351: 20.• *Ballard DW, Li U, Evans J, et al. Fear of litigation may increase resuscitation of

infants born near the limits of viability. J Pediatrics 2002; 140: 713.• Clark FI. Miller is more expansive than previously reported. J Perinatology 2005; 25:

74.• *Kopelman LM. Are the 21-year-old Baby Doe rules understood or mistaken?

Pediatrics 2005; 115: 797.• Mercurio MR. Physicians’ refusal to resuscitate at borderline gestational age. J

Perinatology 2005; 25: 685.• Paris JJ et al. Resuscitation of the preterm infant against parental wishes. Arch Dis

Child 2005; 90: F208.• Paris JJ, Schreiber MD, Reardon F. The emergent circumstances: Exception to the

need for consent: The Texas Supreme Court ruling in Miller v. HCA. J Perinatology 2004; 24: 337.

• Robertson JA. Extreme prematurity and parental rights after Baby Doe. The Hastings Center Report 2004; 18: 19.

• Sayeed SA. Baby Doe redux? The Department of Health and Human Services and Born Alive Infants Protection Act of 2002: A cautionary note on normative pediatric practice. Pediatrics 2005; 116: e576.

• Verhagen E, Sauer PJJ. The Groningen Protocol-euthanasia in severely ill newborns. NEJM 2005; 352:959.

*Recommended

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

Documents