i have no financial relationships to disclose. i will not discuss off-label and/or
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Disclosure Information Theodore R. Thompson, M.D. I have no financial relationships to disclose. I will not discuss off-label and/or investigational use in my presentation. Neonatal Ethics. Theodore Thompson, M.D. Professor of Pediatrics Division of Neonatology - PowerPoint PPT PresentationTRANSCRIPT
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.
University of Minnesota Amplatz Children’s Hospital
Neonatal Ethics
Neonatal EthicsTheodore Thompson, M.D.
Professor of PediatricsDivision of Neonatology
University of Minnesota Medical School
University of Minnesota Amplatz Children’s Hospital
Where I wish I was…
University of Minnesota Amplatz Children’s Hospital
University of Minnesota Amplatz Children’s Hospital
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.
University of Minnesota Amplatz Children’s Hospital
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
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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
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Ethical Decision Making on the NICU
Caring
Compassionate
Communicative
Competent
Committed
Healthcare Team
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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
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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;
University of Minnesota Amplatz Children’s Hospital
University of Minnesota Amplatz Children’s Hospital
University of Minnesota Amplatz Children’s Hospital
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
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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
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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
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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”?
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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
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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?
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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 (quality of life) affect decision making?
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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)
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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?
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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
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Berger, TM. J. Pediatr 2010;156: 7 (January).
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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
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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
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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.
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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
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University of Minnesota Amplatz Children’s Hospital
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
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University of Minnesota Amplatz Children’s Hospital
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
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
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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
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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
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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)
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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)
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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)
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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.
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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
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University of Minnesota Amplatz Children’s Hospital
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
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Neonatology lacks the “holy grail” whereas an intervention/ approach to care will improve survival and decrease the prevalence of disability among survivors
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
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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
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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?
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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?
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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
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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
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University of Minnesota Amplatz Children’s Hospital
Bald Park FigureBald Park FigureThe All No-Hair-to-Spare TeamThe All No-Hair-to-Spare Team
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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)
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University of Minnesota Amplatz Children’s Hospital
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
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University of Minnesota Amplatz Children’s Hospital
University of Minnesota Amplatz Children’s Hospital
University of Minnesota Amplatz Children’s Hospital
• 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
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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%
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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
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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
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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
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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%
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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
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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
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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
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Bottom Line: Best Survival Estimate
23 weeks – 20%
24 weeks – 50%
25 weeks – 65%
26 weeks – 80%
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Bottom Line: Best Intact Survival Estimate
23 weeks: <5%
24 weeks: 10-20%
25 weeks: 30-40%
26 weeks: 50-65%
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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
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Limits of Viability: 2010
• 23 weeks’ gestation
• 400-450 grams birth weight (appropriate growth)
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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
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
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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
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Neonatology lacks the “holy grail” whereas an intervention/ approach to care will improve survival and decrease the prevalence of disability among survivors
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
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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
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University of Minnesota Amplatz Children’s Hospital
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
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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
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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
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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.
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Ethical Decision-Making on the NICU
Parents plus Physicians, Nurses
RelativesClergy Other Support People
Neonatal Ethics Committee
Resolution Child Protective Agency
Court
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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
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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
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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.
University of Minnesota Amplatz Children’s Hospital
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
University of Minnesota Amplatz Children’s Hospital
Neonatology lacks the “holy grail” whereas an intervention/ approach to care will improve survival and decrease the prevalence of disability among survivors
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
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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
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University of Minnesota Amplatz Children’s Hospital
Withdrawal of Neonatal Life Support — Limitations of
Resuscitative Efforts
• Decisions - parents, health care professionals
– Complex
– Stressful
– Tragic
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“Sorry I’m late, but they had me on life support for two months.”
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University of Minnesota Amplatz Children’s Hospital
We are NOTNOT
the placenta
We are NOTNOT
the placenta
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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
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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
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University of Minnesota Amplatz Children’s Hospital
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
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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]
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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
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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)
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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
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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
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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
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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
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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
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Neonatology lacks the “holy grail” whereas an intervention/ approach to care will improve survival and decrease the prevalence of disability among survivors
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
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Neonatal Ethics
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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
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
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Ethical Decisions on the NICU
• 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”?
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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
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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
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“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
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Neonatology lacks the “holy grail” whereas an intervention/ approach to care will improve survival and decrease the prevalence of disability among survivors
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
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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
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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
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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
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• Faith’s Lodge– www.faithslodge.org
• Now I Lay Me Down to Sleep– http://www.nowilaymedowntosleep.org
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Ethics on the NICU
Many extremely premature
infants who survive the neonatal
period will live healthy and
fulfilling lives
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University of Minnesota Amplatz Children’s Hospital
University of Minnesota Amplatz Children’s Hospital
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.
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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.
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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.
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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.
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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
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