Ethical issues of extremely    preterm babies’ care:the “grey zone” experiences               Kyiv, March 6th 2013Dr Lucas...
What are ethics?• “Nothing is either good or bad, but thinking makes  it so” (W. Shakespeare’s Hamlet)• Branch of philosop...
Are ethical choices in medicine easy todefine?  • Classical medical ethical convictions:    Preserve life - at any cost!  ...
Definition of ethical choices in medicine  • Beneficence: best interest of the patient (Salus aegroti suprema lex.)  • Non...
Ethics in neonatology influenced by…       •     Culture - religion - philosophy       •     Sociology - society       •  ...
Ethics in neonatology- We touch the most profound interface betweenmaterialistic, objective medicine and emotionalempathy,...
“In Preemies, Better Care Also Means Hard Choice”      (New York Times August 13, 2012)      Where do we touch the limits?...
Brain development•   12-16 weeks: neuronal proliferation•   12 - 20 weeks: neuronal migration•   20 weeks: neuronal organi...
Gestational age: are we always talking about     the same time?Pediatrics Vol. 114 No. 5 November 1, 2004 pp. 1362 -136 (4...
Estimate of gestational age  • The best obstetric estimate is necessary           - gaps in obstetric information         ...
Viability and its implications• Disability• Psychological   • emotional impact of raising a child with a disability   • th...
Thresholds of viability: some numbers on     SURVIVALS      • Dramatically improved during last 3 decades      • Differenc...
Thresholds of viability: some numbers onSURVIVALS   – Risk of neonatal deaths not higher than 50%, except for infants less...
Thresholds of viability• Survival   – at 24 weeks: 31%   – at 25 weeks 50%Larroque B, Ancel PY, Marchand-Martin L, Camboni...
Thresholds of viability   • > 23 weeks gestation:16% chance of surviving   •      At 24 weeks, survival: 44%   •      At 2...
Morbidity: EPICure (UK, Ireland)    • Follow up of 78% of 308 children born < 25 weeks + 6      days up to 6 years, from 1...
EPICure
Morbidity: EPIPAGE (France)• 77% of 2901 infants between 22 and 32 weeks,  control group of term babies, up to 5 years (no...
Morbidity:The American Academy ofPediatrics:• 30-50% of surviving children with <750g or whosegestation <25 weeks had mode...
Morbidity:Nuffields (GB): •     23 - 24 weeks gestation: 64% risk of serious disability •     At 25 weeks: risk of severe ...
Morbidity: Australia•    Grey zone between 23-25 weeks + 6 days•     Survival to discharge data     - 22w (0)     - 23w (2...
Morbidity: The Netherlands:Leiden follow up project: data since 1983:Death or abnormal development:23-24 wks (92%)25 weeks...
Recommendations: British Association of    Perinatal Medicine22-28 weeks threshold of viability (under 26 weeks)- Increasi...
Recommendations: The American Academy  of Pediatrics:      • 22-25 weeks gestation problematic      • Non-initiation of re...
Recommendations: The Fetus and Newborn  Committee, Canada• 22 weeks: compassionate care only• 23-24 weeks: careful conside...
Recommendations: The Netherlands   • No intensive care to babies before 25-26 weeks gestation   • Decisions should be take...
Recommendations: Australia•      Grey zone between 23-25 weeks + 6 days: option of non-initiation of       resuscitation a...
Malcom F. Should artificial resuscitation be offered to extremely premature neonates? AMSJ 2010 p 86-9
Recommendations: The Nuffield Councilon Bioethics (GB)• 23-26 weeks = grey area• 2 components:- to resuscitate and admit t...
Nuffield Council on Bioethics“Natural instincts are to try to save all babies, even ifthe babys chances of survival are lo...
The Nuffield Council on Bioethics Medical ethics committee of the British Medical Association (BMA): • The report echoes "...
Neonatal section of the Irish Faculty of  Paediatrics• Withdrawal of care appropriate in infants born within thethreshold ...
Recommendations: France• Usually, no resuscitation below 24 WGA• At 24 weeks, particular attention to parents’ wishes• Max...
Recommendations: Switzerland       • < 24 weeks: palliative       • > 24 weeks: according to the experienced neonatology  ...
Recommendations: UkraineGestation period < 28 weeks    • Define the exact gestational age and weightof the fetus, estimate...
Can limits be clearly defined? Summary - No international consensus = chance for avoidance of systematic approaches! - CUT...
Can limits be clearly defined? Outcomeestimation tool Secondary criteriae: - Girls 1 week advantage - Every day increases ...
Time-frame, algorythm for decisionmaking• Primary resuscitation: Y/N• Proceed to intensive care or palliative care• Contin...
Legal - moral: The Best Interests StandardActing in the “best interests of the patient”               • degree of sufferin...
Palliative CareUnited Kingdom: Court of Appeal,1993:Doctors and parent/s may not undertake actions where the purpose isto ...
Palliative Care in France: lois Leonetti (2005)• Legalises arrest of “non-reasonable treatment”• Authorizes, at the end of...
Decision-making for palliative care•. At birth: neither certainty nor uncertainty as prognosis is clear-cut            (Se...
Decision-making for intensive care • Case-by-case basis according postnatal assessment • Factors always to be considered: ...
Divorces after handicap• Nine times higher in case of spina bifida (BJ PSYCH 131: 79-82  (1977)        J. Maulden, Populat...
Ethics and…corticosteroids• Antenatal corticosteroids• A technical, medical, ethical obligation   – No obstetrical or medi...
Ethics and…corticosteroids    • Postnatal corticosteroids in BPD          – Increased risk of neurodevelopmental          ...
Ethics and…iatrogenic diseases-    Environment in which the baby is managed (eg,          light, noise, touch)-    Mode of...
Ethics and…painOpioids for neonates receiving mechanical ventilation   Roberto Bell˘1, Koert A de Waal2, Rinaldo Zanini31N...
Ethics and…aesthetics• End-of-life comfort/appearance for the  – Infant  – Parents  – Caregivers
Ethics and…parents  • Infant-parent emotional bonding           –    Regionalisation           –    Participation of paren...
Parents       When individuals lack decision-making capacity…       …the interests and welfare of the patient take priorit...
Parents: recommendations  • Counselling should initiate before delivery  • Transparency, openness and honesty  • Favour fr...
Communication with parentsMontreal group:52 mothers in preterm labour: all infants at23 weeks gestation were resuscitated,...
Some answers: creation of guidelines /protocolsNot feeling alone, ability to rely on the experience and expertise of other...
A Case Method To Assist Clinical EthicsDecision Making(Modified from American College of Physicians Ethics Manual)•   1. D...
Recommendations     • Define yourself your borderline between viability       according to capacities of your facilities  ...
Much more research…•   Sociological•   Interviews of implicated persons•   Stratification•   EURONIC
Conclusion• Grey zones are grey• It is likely they will stay grey for some time• It would be an error to wash them white o...
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Ethical issues of extremely preterm babies’ care: the “grey zone” experiences

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International conference «Actual approaches to the extremely preterm babies: International experience and Ukrainian realities» (Kyiv, Ukraine, March 5-6, 2013)

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Ethical issues of extremely preterm babies’ care: the “grey zone” experiences

  1. 1. Ethical issues of extremely preterm babies’ care:the “grey zone” experiences Kyiv, March 6th 2013Dr Lucas OpitzAnaesthesia and Intensive Care NICU - PICUCentre Hospitalier Universitaire - GCSNice, France
  2. 2. What are ethics?• “Nothing is either good or bad, but thinking makes it so” (W. Shakespeare’s Hamlet)• Branch of philosophy, addresses questions about morality = concepts such as good and bad, right and wrong, justice and virtue• The study of the general nature of morals and of the specific moral choices to be made by a person or a profession
  3. 3. Are ethical choices in medicine easy todefine? • Classical medical ethical convictions: Preserve life - at any cost! • Life or death = all or nothing = 100% or 0% • At the threshold of viability in preterm babies: “in-between status”: prognosis quod valitudinem difficult to predict
  4. 4. Definition of ethical choices in medicine • Beneficence: best interest of the patient (Salus aegroti suprema lex.) • Non-maleficence: "first, do no harm" (primum non nocere). • Autonomy: the patient has the right to refuse or choose his treatment. (Voluntas aegroti suprema lex.) • Justice: distribution of scarce health resources, decision of who gets what treatment. • Dignity: the patient (and the person treating the patient) have the right to dignity. • Truthfulness • Honesty
  5. 5. Ethics in neonatology influenced by… • Culture - religion - philosophy • Sociology - society • Individual convictions • Cost • Fears, dilemmas, taboos • Juridical backgroundsSingh M. Ethical and social issues in the care of the newborn. Indian J Pediatr. May 2003;70(5):417-20
  6. 6. Ethics in neonatology- We touch the most profound interface betweenmaterialistic, objective medicine and emotionalempathy, personal conviction- Tragic situations leave only tragic options
  7. 7. “In Preemies, Better Care Also Means Hard Choice” (New York Times August 13, 2012) Where do we touch the limits?• Skin immaturity• Fluid balance instability• Lung immaturity and breathing problems• Malnutrition and gut damage• Retinopathy of prematurity• Early and late onset infections• Brain damage which can lead to a spectrum of long-termneurological sequelae = THE MAIN ETHICAL ISSUE
  8. 8. Brain development• 12-16 weeks: neuronal proliferation• 12 - 20 weeks: neuronal migration• 20 weeks: neuronal organisation: inside-out layering of the cortical neurones, synaptogenesis• 26 -28 weeks: rapid gyral growth• Myelinization starts at 20 weeks gestation, continues for many years postnatally• 29-40 weeks: 2.7 fold increase in brain volume, 4 fold increase in grey matter volume• Brain folding: coffee bean  walnut
  9. 9. Gestational age: are we always talking about the same time?Pediatrics Vol. 114 No. 5 November 1, 2004 pp. 1362 -136 (4doi: 10.1542/peds.2004-1915)
  10. 10. Estimate of gestational age • The best obstetric estimate is necessary - gaps in obstetric information - inherent variability (as great as 2 weeks) in traditional methods of gestational age estimation - postnatal physical examination inaccurate • First trimester ultrasound: golden standard (margin of error: a few days) • Methods should be clearly statedWisserl J. Et al Estimation of gestational age by transvaginal sonographic measurement of greatest embryonic length indated human embryos Ultrasound in Obstetrics & Gynecology Volume 4, Issue 6, pages 457–462, 1 November 1994Bulletin of the World Health Organization The worldwide incidence of preterm birth: a systematic reviewof maternal mortality and morbidity Stacy Beck, Daniel Wojdyla
  11. 11. Viability and its implications• Disability• Psychological • emotional impact of raising a child with a disability • the child himself: depression, anxiety, aggression, lower self concept (Rachel Levy Shifft and Gili Einat, Journal of Clinical Child Psychology V 23 p 328-9)• Financial: - US, 2003: Premature newborns = US$18.1 billion in health care costs = half of total hospital charges for newborn care + ongoing costs for the health system (1,4 billion on less of 1,25 USD/day)• Societal
  12. 12. Thresholds of viability: some numbers on SURVIVALS • Dramatically improved during last 3 decades • Differences in methodology • Few studies have reported mortality and morbidity rates in gestational age-specific categoriesPreterm Birth: Causes, Consequences, and Prevention.Institute of Medicine (US) Committee on Understanding PrematureBirth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors.Washington (DC): National Academies Press (US); 2007.
  13. 13. Thresholds of viability: some numbers onSURVIVALS – Risk of neonatal deaths not higher than 50%, except for infants less the 500g and 24 weeks gestation Stringer M, Brooks PM et al: New guidelines for maternal and neonatal resuscitation. Journal of obstetrics, gynecology and neonatal nursing 2007; 36(6), 624 -34 – At 24 weeks, survival = 58% – At 25 weeks = 77% – Not precised for < 24 weeks – Survival vary from 1% at 22 weeks to up to 44% at 25 weeks. – Before 21 weeks and six days, no survival published Brazier M et al Letting babies die J Med Ethics 2007; 33 (3) 125-6
  14. 14. Thresholds of viability• Survival – at 24 weeks: 31% – at 25 weeks 50%Larroque B, Ancel PY, Marchand-Martin L, Cambonie G, Fresson J, Pierrat V, et al. Special care school diffiulties in8- year-old very preterm children: the Epipage cohort study. PLoS ONE 2011; 6: e21361. – at 23 and 24 weeks gestation varies from 10-50% – at 25 weeks gestation: 50 - 80%Fetus and newborn committee, Canadian paediatric society, maternal-fetal medicine committee, society of obstetricians andgynaecologists of Canada. Management of the woman with threatened birth of an infant of extremely low gestational age.Can Med Assoc J 1994;151:547-53. - 22w (0), 23w (29%), 24w (50%), 25w (65%).Aust N Z J Obstet Gynaecol 2007 Aug;47(4):273-8.Delivery in the grey zone: collaborative approach to extremelypreterm birth. Keogh J et al Consensus Workshop Organising Committee
  15. 15. Thresholds of viability • > 23 weeks gestation:16% chance of surviving • At 24 weeks, survival: 44% • At 25 weeks survival: 63% • Each day increases survival by 3%.Nuffield Council on Bioethics. Critical care decisions in fetal and neonatal medicine: ethical issues.London:NCB,2006. www.Nuffieldbioethics.org/go/ourwork/neonatal/publication 406.html.
  16. 16. Morbidity: EPICure (UK, Ireland) • Follow up of 78% of 308 children born < 25 weeks + 6 days up to 6 years, from 1995 on • 12% cerebral palsy • < 750g: 30 - 50% moderate or severe disability • 41% cognitive problems (-2SD) compared to classmates • Survivers of 24 weeks: 14% with no handicap • Survivers of 25 weeks: 24% with no handicapMarlow N, Wolke D, Bracewell MA, Samara M, The EPICure Study Group. Neurologic disability at six years of age afterextremely preterm birth. N Engl J Med 2005; 352
  17. 17. EPICure
  18. 18. Morbidity: EPIPAGE (France)• 77% of 2901 infants between 22 and 32 weeks, control group of term babies, up to 5 years (not finely sliced!)• < 27 weeks, -1DS of QI, attention deficit, language and behaviour disorders,Larroque B, Ancel PY, Marchand-Martin L, Cambonie G, Fresson J, Pierrat V, et al. Special care school diffiulties in8- year-old very preterm children: the Epipage cohort study. PLoS ONE 2011; 6: e21361.
  19. 19. Morbidity:The American Academy ofPediatrics:• 30-50% of surviving children with <750g or whosegestation <25 weeks had moderate or severe disabilityStringer M, Brooks PM et al: New guidelines for maternal and neonatal resuscitation. Journal of obstetrics,gynecology and neonatal nursing 2007; 36(6), 624 -34
  20. 20. Morbidity:Nuffields (GB): • 23 - 24 weeks gestation: 64% risk of serious disability • At 25 weeks: risk of severe disability: 40%. • Each day increases survival by 3%. • Girls have a week’s advantage over preterm boysNuffield Council on Bioethics. Critical care decisions in fetal and neonatal medicine: ethical issues.London:NCB,2006. www.Nuffieldbioethics.org/go/ourwork/neonatal/publication 406.html.
  21. 21. Morbidity: Australia• Grey zone between 23-25 weeks + 6 days• Survival to discharge data - 22w (0) - 23w (29%) - 24w (50%) - 25w (65%).• Proportion with no functional disability 23w (33%), 24w (61%), 25w (67%)
  22. 22. Morbidity: The Netherlands:Leiden follow up project: data since 1983:Death or abnormal development:23-24 wks (92%)25 weeks (64%)26 weeks (35%)27-32 weeks (18%)Sheldon T. Dutch doctors change policy on treating preterm babies. BMJ 2001;322:1383Rijken M et al Mortality and Neurologic, Mental, and Psychomotor Development at 2 Years in Infants Born less than 27 WeeksGestation: The Leiden Follow-Up Project on Prematurity, Pediatrics january 2003
  23. 23. Recommendations: British Association of Perinatal Medicine22-28 weeks threshold of viability (under 26 weeks)- Increasing risk with decreasing gestational ageserious ethical dilemmas- Short notice decisions- Need to balance maternal well-being against thelikely neonatal outcome- Caesarean section in the baby’s interestscan rarely be justified prior to 25 weeks gestation.- Threshold viability infants should be followed up forat least 2 years: data collectionBritish Association of Perinatal Medicine. Fetuses and newborn infants at the threshold of viability. Pediatr 2002;110:1024-27.
  24. 24. Recommendations: The American Academy of Pediatrics: • 22-25 weeks gestation problematic • Non-initiation of resuscitation at 23 weeks (less 400g) is appropriate • Difficulties in making accurate assessments before birth • Fetal weight can be inaccurate by 15-20% • Small discrepancies in gestation of 1 or 2 weeks can have major implications for outcome • Multiple gestation makes evaluation difficult • Counselling • But: US: legal trends restrict discretionary decision-makingThe Marginally Viable Newborn: Legal Challenges, Conceptual Inadequacies, and Reasonableness.Sadath A. Sayeed M.D., J.DThe Journal of Law, Medicine & Ethics Volume 34, Issue 3 600-610, 2006Stringer M, Brooks PM et al: New guidelines for maternal and neonatal resuscitation. Journal of obstetrics,gynecology and neonatal nursing 2007; 36(6), 624 -34
  25. 25. Recommendations: The Fetus and Newborn Committee, Canada• 22 weeks: compassionate care only• 23-24 weeks: careful consideration: limited benefits and potential harms of caesarean section and active resuscitation• Full care 25 weeks(survival rate is 50-80% with disability rates 10-25%)Fetus and newborn committee, Canadian paediatric society, maternal-fetal medicine committee, society of obstetricians andgynaecologists of Canada. Management of the woman with threatened birth of an infant of extremely low gestational age.Can Med Assoc J 1994;151:547-53.
  26. 26. Recommendations: The Netherlands • No intensive care to babies before 25-26 weeks gestation • Decisions should be taken with full participation of the parents • Unclear cutoff of resuscitation of immature infants: - at 25%, 50% or 75% chance of intact survival? - (Viability not universally agreed, thus: if bar is set low there will be more survivors with more handicaps) • Euthanasia institutionalisedSheldon T. Dutch doctors change policy on treating preterm babies. BMJ 2001;322:1383.
  27. 27. Recommendations: Australia• Grey zone between 23-25 weeks + 6 days: option of non-initiation of resuscitation and intensive care reasonable - obligation to treat increases as the gestation advances - at 25 weeks active treatment is usually offered - unless adverse circumstances: • twin-twin transfusion, • intrauterine growth restriction • chorioamnionitis. • poor condition at birth or the presence of a serious abnormality - at 26 weeks gestation the obligation to treat is very high - non-directive counselling, avoidance of over burdening parents• 24 weeks antenatal transfer to a tertiary centre, with option of “DNR” Aust N Z J Obstet Gynaecol. 2007 Aug;47(4):273-8.Delivery in the grey zone: collaborative approach to extremely preterm birth .Keogh J, Sinn J, Hollebone K, Bajuk B, Fischer W, Lui K; Consensus Workshop Organising Committee
  28. 28. Malcom F. Should artificial resuscitation be offered to extremely premature neonates? AMSJ 2010 p 86-9
  29. 29. Recommendations: The Nuffield Councilon Bioethics (GB)• 23-26 weeks = grey area• 2 components:- to resuscitate and admit to the NICU- to continue with intensive care or replace withpalliative care• Recommendations - at 25 weeks and above institute intensive care - 24-25 weeks offer intensive care unless different parents’ wishes - 23- 24 weeks clinicians should not be obliged to resuscitate Nuffield Council on Bioethics. Critical care decisions in fetal and neonatal medicine: ethical issues. London:NCB,2006. www.Nuffieldbioethics.org/go/ourwork/neonatal/publication 406.html.
  30. 30. Nuffield Council on Bioethics“Natural instincts are to try to save all babies, even ifthe babys chances of survival are low.However, we dont think it is always right to put a babythrough the stress and pain of invasive treatment if thebaby is unlikely to get any better and death isinevitable.(Margaret Brazier, professor of law at Manchester University)Prolonging the life of profoundly sick premature babiesmay be "inhumane" and place an "intolerable burden onthe baby”,"treatment just prolongs the process of dying,” (Andrew Whitelaw, professor of neonatal medicine at the University of Bristol, UK)
  31. 31. The Nuffield Council on Bioethics Medical ethics committee of the British Medical Association (BMA): • The report echoes "existing best practice” • Disagreement with stringent cut-off points for treatment. - "The BMA believes that blanket rules do not help individual parents or their very premature babies” - "Each case should be considered on its merits andin its own context” (Tony Calland) When premature babies should be allowed to die, Gaia Vince, New scientist, 15 November 2006
  32. 32. Neonatal section of the Irish Faculty of Paediatrics• Withdrawal of care appropriate in infants born within thethreshold period who fail to respond to initial intensive careefforts or develop severe complications• Acceptable not to resuscitate newbornsunder 500g and/or under 24 weeks gestation. Neonatal subcommittee of the Irish faculty of Paediatrics. Statement on perinatal care at the threshold of viability.2006.
  33. 33. Recommendations: France• Usually, no resuscitation below 24 WGA• At 24 weeks, particular attention to parents’ wishes• Maximum degree of uncertainty on the real interest of the patient: nobody can pretend to claim which is the best attitude• Other criteriae to be taken into account (discretional resuscitation): • Prenatal corticosteroids Moriette G Rameix S et al groupe de réflexion sur les aspects éthiques de la périnatologie very premature births: dilemmas and management. Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone. Archives de Pédiatrie 2010 May17(5):518-26, part 2 527-39
  34. 34. Recommendations: Switzerland • < 24 weeks: palliative • > 24 weeks: according to the experienced neonatology teamSwiss Society of Neonatology: recommandations pour la prise en charge des prématurés à la limite de la viabilité (22 - 26 SA) 2002
  35. 35. Recommendations: UkraineGestation period < 28 weeks • Define the exact gestational age and weightof the fetus, estimate prognosis, provide further consultations, recommendations and coordinate team work of all members of perinatal team • Inform and discuss with future parents about medical and social risks and peculiarities of resuscitation care providing for the newborn • Resuscitation is almost always provided if high survival chances and acceptable morbidity • In case of doubtful prognosis: necessity to support the wish of parents • Do not start the resuscitation of a newborn, if almost 100% early death rate likely (I.e.: gestation period < 23 weeks, weight < 400 gr)
  36. 36. Can limits be clearly defined? Summary - No international consensus = chance for avoidance of systematic approaches! - CUTOFF, borderline of viability: - 50% of mortality, but disability difficult to objectify and use as a criteria - All would resuscitate at 26 weeks, most would not at 23 weeks - Grey area: 24 and 25 weeks gestation = 2 per 1000 births - fetal weight: 10% error - gestational age: 3 - 5 days error
  37. 37. Can limits be clearly defined? Outcomeestimation tool Secondary criteriae: - Girls 1 week advantage - Every day increases survival by 3% - Full course of antenatal steroids - Level of unit - Black race - High-medium level of income of parents - Multiple birth, twin-to-twin transfusion - Birth weight - Baby’s condition at delivery (chorioamnionitis increases the risk of periventricular leucomalacia)
  38. 38. Time-frame, algorythm for decisionmaking• Primary resuscitation: Y/N• Proceed to intensive care or palliative care• Continue with option Y/N• Euthanasia – Netherlands (Groningen Protocol) • To motivate physicians to adhere to the highest standards of decision making • To reduce hidden euthanasia by facilitating reporting • Requires that all possible palliative measures be exhausted before euthanasia is performed • Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice – EURONIC: 73% in 8 European Countries Rebagliato M et al.: EURONIC study group. Neonatal end-of-life decision making: Physician’s attitudes and relationships with self-reported practices in 10 European countries. The Journal of Medical Association. 2000 Nov 15;284(19):2451-9
  39. 39. Legal - moral: The Best Interests StandardActing in the “best interests of the patient” • degree of suffering involved in the care • futility of further intervention • likelihood of survival free of serious disability and practical consequences
  40. 40. Palliative CareUnited Kingdom: Court of Appeal,1993:Doctors and parent/s may not undertake actions where the purpose isto end life, they may, in appropriate circumstances, use drugs torelieve pain and distress, even though their use may advance the timeof death.
  41. 41. Palliative Care in France: lois Leonetti (2005)• Legalises arrest of “non-reasonable treatment”• Authorizes, at the end of life, the use of treatment for comfortof patient (pain)• Taking into account that the treatment might shorten length ofsurvival• Always with the patient’s consent = parent’s consent!Recently, French Medical Council expressed itself in the same terms
  42. 42. Decision-making for palliative care•. At birth: neither certainty nor uncertainty as prognosis is clear-cut (Self-fullfilling prophecy may be created by delays or suboptimal management)• Initiation of resuscitation leads to admission to NICU: - cascade of expensive, uncomfortable or painful procedures - raise parental expectations about survival• Denying intensive care a priori, based solely on the age ofgestation or birth weight = contrary to the principle of equity• Decision-making after initial resuscitation (continue or withdrawtreatment) more justifiableActa Paediatr. 2008 Mar;97(3):276-9. doi: 10.1111/j.1651-2227.2008.00663.x.Caregivers attitudes for very premature infantswhat if they knew?Janvier A, Lantos J, DeschÍnes M, Couture E, Nadeau S, Barrington KJ
  43. 43. Decision-making for intensive care • Case-by-case basis according postnatal assessment • Factors always to be considered: - parents - resources, - planned pregnancy - assisted conception, - maternal age - illness and fetal conditions Decisions made by parents before birth are not necessarily absolute and binding.
  44. 44. Divorces after handicap• Nine times higher in case of spina bifida (BJ PSYCH 131: 79-82 (1977) J. Maulden, Population studies, vol 46, issue2, pages 349 362 (1992)• Low birth weight children in the US are at higher risk of experiencing their parents divorce than children of normal birth weight• Not confirmed in British couplesHealthy Baby, Healthy Marriage? The Effct of ChildrensHealth on Divorce Angela R. Fertig Princeton University288 Wallace Hall Princeton, NJ 08544afertig@princeton.edu 609-258-5868 June 17, 2004
  45. 45. Ethics and…corticosteroids• Antenatal corticosteroids• A technical, medical, ethical obligation – No obstetrical or medical CI (infection, hypertension) – C. Spencer, K. Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000; 320 : 325 doi: 10.1136/bmj.320.7231.325 (Published 5 February 2000) – Roberts D, Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The Cochrane Database of Systematic Reviews 2010 Issue 8, Copyright © 2010 The Cochrane Collaboration. – J.V Been, B W Kramer, L J Zimmermann Antenatal corticosteroids to prevent preterm birt The Lancet,Vol 373, Issue 9667, Page 894, 14 March 2009
  46. 46. Ethics and…corticosteroids • Postnatal corticosteroids in BPD – Increased risk of neurodevelopmental impairment, growth retardation etc, but faster extubation, less PDA etc…. – “Ethically” contraindicated?? Early (< 8 days) postnatal corticosteroids for preventing chronic lung disease in preterm infants Henry L Halliday1, Richard A Ehrenkranz2, Lex W Doyle31Perinatal Room, Royal-Jubilee Maternity Service, Belfast, UK. 2Department of Pediatrics, Yale University, New Haven, Connecticut, USA. 3Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, AustraliaContact address: Henry L Halliday, Perinatal Room, Royal-Jubilee Maternity Service, Royal Maternity Hospital, Grosvenor Road, Belfast, Northern Ireland, BT12 6BA, UK. Cochrane Neonatal Group
  47. 47. Ethics and…iatrogenic diseases- Environment in which the baby is managed (eg, light, noise, touch)- Mode of ventilation (eg, conventional, synchronized, high-frequency)- Types, doses, and results of medications used- Short-term and long-term effects of certain, often painful procedures- Foreign bodies or devices used- How the babys nutritional needs are met (enteral, parenteral nutrition)Developmental care for promoting development and preventing morbidity in preterm infants Amanda J Symington1, Janet Pinelli2 1The Childrens Hospital, Hamilton Health Sciences, Hamilton, Ontario, Canada. 2School of Nursing, McMaster University, Hamilton, CanadaCochrane Neonatal Group.
  48. 48. Ethics and…painOpioids for neonates receiving mechanical ventilation Roberto Bell˘1, Koert A de Waal2, Rinaldo Zanini31Neonatal Intensive Care Unit, Ospedale "Manzoni" -Lecco, Lecco, Italy. 2Neonatology, Academic Medical Centre, Amsterdam, Netherlands. 3Neonatal Intensive Care Unit, Ospedale "A. Manzoni" - Lecco, Lecco, ItalyContact address: Roberto Bell˘, Neonatal Intensive Care Unit, Ospedale "Manzoni" -Lecco, Via Eremo 9, Lecco, 23900, Italy.Editorial group: Cochrane Neonatal Group.Intravenous midazolam infusion for sedation of infants in the neonatal intensive care unit Eugene Ng1, Anna Taddio2, Arne Ohlsson31Department of Newborn and Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Canada. 2Graduate Department of Pharmaceutical Sciences, Hospital for Sick Children Research Institute, Toronto, Canada. 3Departments of Paediatrics, Obstetrics and Gynaecology and Health Policy, Management and Evaluation, University of Toronto, Toronto, CanadaContact address: Eugene Ng, Department of Newborn and Developmental Paediatrics, Sunnybrook Health Sciences Centre, C/O Womens College Hospital, 76 Grenville Street, Toronto, Ontario, M5S1B2, Canada.Editorial group: Cochrane Neonatal Group.
  49. 49. Ethics and…aesthetics• End-of-life comfort/appearance for the – Infant – Parents – Caregivers
  50. 50. Ethics and…parents • Infant-parent emotional bonding – Regionalisation – Participation of parents in healing process – Skin-to-skin – Informed consent – Decision makingRaines DA. Parents values: a missing link in the neonatal intensive care equation. Neonatal Netw. Apr 1996;15(3):7-12.
  51. 51. Parents When individuals lack decision-making capacity… …the interests and welfare of the patient take priority over all other parties …the interests of the neonate are inextricably linked to that of the parents their interests must be taken into account, empowering them to decision-makingKent AL, et al. Collaborative decision-making for extreme premature delivery. J Paediatr Child Health 2007; 43: 489-91.
  52. 52. Parents: recommendations • Counselling should initiate before delivery • Transparency, openness and honesty • Favour frequent discussions with parents • Update them on – their infants condition – interventions that may be needed • Avoid confusing medical terminology as much as possible • Be honest and frank about the infants condition and prognosis, even on matters of uncertainty • Ask feed backs to ensure parents understand what is being discussedCaeymaex L, ed al: Journées Parisiennes de Pédiatrie 2008 Fin de vie en réanimation néonatale: mieuxcomprendre les attentes et le point de vues des parentsCollaborative decision-making for extreme premature delivery.Kent AL et al NSW and ACT Perinatal Care at the Borderlinesof Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun;43(6):489-91.
  53. 53. Communication with parentsMontreal group:52 mothers in preterm labour: all infants at23 weeks gestation were resuscitated, including6 cases with conditional non-resuscitation instructionsThus:- In acute situations the default mode is to treat- To step back from action seems to be very difficult
  54. 54. Some answers: creation of guidelines /protocolsNot feeling alone, ability to rely on the experience and expertise of others is helpful. – Expertise – Enabling – Empowering – Encouraging – Education
  55. 55. A Case Method To Assist Clinical EthicsDecision Making(Modified from American College of Physicians Ethics Manual)• 1. Define the ethics problem as an "ought" or "should" question. (e.g." "Should we withhold a respirator for this extremely preterm baby 25 WGA as his parents request?")• 2. List relevant facts and uncertainties. Include facts about the patient and caregivers (such as emotional state, cultural background, and legal standing). Include physiologic facts and significant medical uncertainties (such as expected outcomes with and without treatment), and the benefits and harms of treatment options.• 3. Identify a decision maker. If the patient is competent, the decision maker is the patient. If the patient is incompetent, identify a proxy decision maker (e.g., as specified by court appointment, state law, a durable power of attorney for health care, living will, or the next of kin.)• 4. Give understandable, relevant, desired information to the decision maker and dispel misconceptions.• 5. Solicit values of the patient that are relevant to the question. These include the patients values about life; relation to community and health care institutions; goals for health care and conditions that would change goals; and preferences about health care or proxy decision makers.• 6. Identify health professional values, including health goals (such as prolonging life and alleviating pain), values that pertain to patient physician communication (such as truth telling and confidentiality), and some values that extend outside of the patient physician relationship (such as promotion of public health, and respect for the law).• 7. Propose and critique solutions, including options for treatment and alternative providers.• 8. Identify and remove or address constraints on solutions (such as unavailability of services, laws, or legal myths).
  56. 56. Recommendations • Define yourself your borderline between viability according to capacities of your facilities – Neurological outcomes – Respiratory outcomes – Caloric intakeCatlin A, Carter B. Creation of a neonatal end-of-life palliative care protocol. J Perinatol.Apr-May, 2002;22(3):184-95
  57. 57. Much more research…• Sociological• Interviews of implicated persons• Stratification• EURONIC
  58. 58. Conclusion• Grey zones are grey• It is likely they will stay grey for some time• It would be an error to wash them white or darken them• Grey zones have to be adapted to the local contexts• Every ward/hospital/maternity should allow open discussions, have a committee on ethics, establish internal guidelines• The role of the parents in decision-making after as-objective-as- possible information given by healthcare members is essential• Making ethical decisions might be very difficult, but ethical relationships with the preterm and his parents can compensate this

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