1. The Right to Exist Beau Batton, MD
Associate Professor of Pediatrics & Chief of Neonatology
Southern Illinois University School of Medicine
Director of Newborn Services, St. John’s Children’s Hospital

2. Disclosures None

3. Objectives Understand the complexity of “borderline viability”
Realize this is an emotional issue, not a scientific one
Understand the inconsistencies in our views of this subject and this patient population

4. A patient arrives to the hospital in need of cardio- pulmonary resuscitation. Her wishes for life-sustaining therapies are not known. Although the situation is not hopeless, there is a substantial risk for death or neurological morbidity.
What is the approach to such a patient in the Emergency Department?
What is the approach if this patient is an infant born at around 23 weeks gestation?
Why are there discrepancies between the two?

5. What is Viability?
Shortest duration of pregnancy after which a child born prematurely has a chance of survival
How much of a chance?
Duration of survival?
Risks of neurodevelopmental morbidity?
So then, what is “borderline viability”?

6. Background Controversy dates back at least five decades
The GA range for “borderline viability” has changed
The approach to these infants has not changed – some receive life-sustaining care, some do not
With a selective approach, there are some patients who die with comfort care measures who would have done well had they received intensive care
And there are some infants destined to die irrespective of therapeutic interventions who do so in the ICU
We rarely know which is which

7. Background
In the United States, 22 to 23 weeks GA appears to be the current GA range of “borderline viability”:
GA (weeks) 22 23 24 25 26
Received active treatment*
22%
72%
97%
>99%
*surfactant, ETT, PPV, CC, epinephrine, TPN
Rysavy, et al. NEJM 2015

8. Current Guidelines
Guillen. Pediatrics; 2015

9. Current Controversies
Accuracy of estimated GA
Perinatal factors other than GA also matter
There isn’t always enough time for consultation
Not everyone counsels the same way
Impact of initial DR care
Accurately predicting outcomes
Parent’s requests may be unreasonable
Distinct from similar situations in other areas of medicine

10. Estimated GA
Leuthner. Clinics in Perinatology; 2014

11. Perinatal Factors Beyond GA Gestational Age at Birth (weeks)
Inborn Survival (1994 – 2004)
Percent 23 24 25 26 27 29 30 28 31
Gestational Age at Birth (weeks)
Pink = Female
Blue = male
Underlined = received antenatal steroids

12. Inborn Survival without Acute Morbidity* (1994-2004)
Perinatal Factors Beyond GA
Inborn Survival without Acute Morbidity* ( )
Percent 23 24 27 25 26 29
Gestational Age at Birth (weeks)
Pink = Female
Blue = male
Underlined = received antenatal steroids
*Severe IVH, PVL, ROP ≥ stage IV, > 3mth ventilator support

13. Perinatal Factors Beyond GA
Tyson, et al. NEJM 2008:
Gestational age
Birth weight (estimated fetal weight)
Antenatal corticosteroids
Sex
Singleton birth
Additional variables:
IUGR
Mode of delivery

14. Insufficient Time for Consultation
Guidelines: qualified person should assess the infant and provide appropriate care based on his or her clinical judgement
Physicians tend to resuscitate extremely preterm infants when there is uncertainty about either the infant’s situation or parental preferences are unknown
Griswold. Pediatrics; 2010
Doren. Pediatrics; 1998

15. Variability in Prenatal Consultations
Information conveyed
Accuracy of data given
Language used
Quality of communication skills
Discussion of disabilities / long-term outcomes

16. Information Conveyed
Bastek. Pediatrics; 2005

17. Bastek. Pediatrics; 2005

18. Accuracy of Data Given
Morse. Pediatrics; 2000

19. Accuracy of Information
Morse. Pediatrics; 2000

20. Language Used Haward. Pediatrics; 2008: Framing effects
Haward. Clinic Perinatol; 2011:
Is the focus on the sanctity of life (immediate survival) or quality of life (long-term consequences)?
Janvier. Acta Paed; 2012:
Comprehensible – parents often forget or misunderstand information presented

21. Quality of Communication
Staub. Acta Paed; 2014 (parental perspectives of prenatal consultation):
Categorization of situation / infant
Concerns about GA based policies – “easier for physicians, not parents”
Empower parents – by understanding their perspectives and addressing their concerns
Focus on values instead of statistics and probabilities
Incorporate perspectives of parents with similar circumstances
Allow parents to hope

22. Discussion of Disabilities
Percent (%)
NICHD Outcomes: Percentage of survivors who survive intact
Gestational Age (weeks)

23. Meadow. Clin Perinatol; 2012

24. Impact of Initial DR Care
Handley. J Perinatol; 2015

25. Impact of Initial DR Care
Wycoff. J Peds; 2012

26. Impact of Initial DR Care
Wycoff. J Peds; 2012

27. Accurately Predicting Outcomes
Meadow. Clin Perinatol; 2012

28. Accurately Predicting Outcomes
Meadow. Pediatrics; 2002

29. Unreasonable Requests from Parents
A mother at 23 6/7 weeks GA is in preterm labor and likely to deliver soon. She and her husband have two healthy children at home. Both parents are fully informed about the risks of being born at an extremely low gestational age.
They have requested their infant not be resuscitated after delivery.

30. Unreasonable Requests from Parents
A mother at 32 6/7 weeks GA is in preterm labor and likely to deliver soon. She and her husband have two healthy children at home. Both parents are fully informed about the risks of being born at an extremely low gestational age.
They have requested their infant not be resuscitated after delivery.

31. Unreasonable Requests from Parents
A mother at 19 6/7 weeks GA is in preterm labor and likely to deliver soon. She and her husband have two healthy children at home. Both parents are fully informed about the risks of being born at an extremely low gestational age.
They have requested their infant not be resuscitated after delivery.

32. Unreasonable Requests from Parents
A mother at 23 6/7 weeks GA is in preterm labor and likely to deliver soon. The fetus is a girl. She and her husband have two healthy girls at home. Both parents are fully informed about the risks of being born at an extremely low gestationl age.
They have requested their infant not be resuscitated after delivery because, “we already have two girls at home and we only want a boy.”

33. Unreasonable Requests from Parents
A mother at 23 6/7 weeks GA with twins is in preterm labor and likely to deliver soon. One fetus is a boy, the other is a girl. She and her husband have two healthy girls at home. Both parents are fully informed about the risks of being born at an extremely low gestational age.
They have requested the boy be resuscitated after delivery, but not the girl because, “we already have two girls at home and we only want a boy.”

34. Unreasonable Requests from Parents
A mother at 23 6/7 weeks GA with twins is in preterm labor and likely to deliver soon. One fetus has Down Syndrome, the other has a normal karyotype. She and her husband have two healthy children at home. Both parents are fully informed about the risks of being born at an extremely low gestational age.
They have requested that only the infant with a normal karyotype be resuscitated after delivery.

35. Other Areas in Medicine
A patient arrives to the hospital in need of cardio- pulmonary resuscitation. Her wishes for life-sustaining therapies are not known. Although the situation is not hopeless, there is a substantial risk for death or neurological morbidity.
Patient ED DR
Adult, OHCA
23 weeks GA
Survival to hospital D/C, %
~10%
~40%
Neurologically intact survival, %
~8%
~20%
Initial resuscitation
Universal
Selective

36. Best Interest to Resuscitate?
Percent
Patient:
80 y/o*
50 y/o
35 y/o
14 y/o
7 y/o†
2 mth
Term
24 wk¥
Condition:
stroke
trauma
brain
tumor
AML
meningitis
malform
preterm
Survival:
50% 5%
Severe Morbidity:
(new)
25%
100%
20%
*Pre-existing dementia; †Pre-existing CP, deafness, learning disabilities, hyperactivity
Janvier. Pediatrics; 2008

37. Other Considerations Legal guidelines Cost of care
Impact of active treatment

38. Legal Guidelines Courts seem hesitant to assign blame post-hoc
Legal ramifications when providers & family members agree on a plan care is extremely rare
Four notable cases of unilateral decision making (either a parent or physician) – all acquittals
Born-Alive Law of 2002
Emergency Medical Treatment & Labor Act (EMTALA)
Child Abuse Prevention &Treatment Act (CAPTA)

39. Legal Guidelines
Law has supported the idea that a periviable birth is an emergency
No clear answer as to whether such deliveries constitute an emergency waiver of informed consent
Stacking of some case law and federal regulations could be interpreted as a claim that all infants should be given a trial of assessment and treatment
No such cases noted to date

40. The Cost of Extremely Preterm Birth
~0.2% of infants in the United States are born at 22 or 23 weeks GA annually (CDC Vital Statistics)
~85% of deaths are in the 1st week (Patel. NEJM; 2015)
NICU costs for survivors is typically >$500,000
Out-of-hospital costs after discharge are also significant
~$9.3 billion (~$1 million / infant) annually
2011 total healthcare expenditures in the United States: $2.7 trillion (Centers for Medicare and Medicaid Services)

41. Meadow. Clin Perinatol; 2012

42. Impact of Active Treatment
Rysavy. NEJM; 2015

43. Rysavy. NEJM; 2015

44. Serenius. Pediatrics; 2015

45. Impact of Active Treatment
Smith. Pediatrics; 2012

46. Conclusions
Deciding whether another person is afforded the chance to live is not supposed to be easy

47. Conclusions
Deciding whether another person is afforded the chance to live is not supposed to be easy
The best interests of a patient with a chance to survive and do well is rarely served by withholding beneficial therapies
For the extremely preterm infant with an uncertain prognosis, such therapies include antenatal corticosteroids, initial DR support, and surfactant

48. Conclusions
When extremely premature infants live, both they and their families are almost always grateful for their survival irrespective of the long-term consequences
Ethically equivalent withdrawal of medical care can occur later when more information is available and parents have had more time to process the situation
Given these factors, withholding life sustaining medical interventions immediately upon delivery from patients who may do well if supported seems to unnecessarily deny them of their Right to Exist

49. THANK YOU

50. AAP COFN (2009)
A qualified provider should attend the delivery of an infant born at the border of viability to ensure appropriate assessment and care of the infant occurs irrespective of discussions or decisions made prior to delivery
If survival is not considered possible, resuscitation is not indicated and should not be done

51. AAP COFN (2009)
If the judgment of the caregiver is that there is a reasonable chance for survival then resuscitation is indicated and should be done
If the opinion of the caregivers is that the chance for survival is possible but very remote then the decision to resuscitate should be left to the parents and their choice shall be respected

52. Born-Alive Act
Defines a "Born alive infant" as a “person, human being, child, or individual"
Gives rights as a human to any child born within the United States
Defines "Born Alive" as the complete expulsion of an infant at any stage of development that has a heartbeat, pulsation of the umbilical cord, breath, or voluntary muscle movement

53. EMTALA Emergency Medical Treatment and Active Labor Act
Requires hospital Emergency Departments that accept payments from Medicare to provide an appropriate medical screening examination to individuals seeking treatment for a medical condition, regardless of citizenship, legal status, or ability to pay
Requires an exam and assessment
Does not define assessment or mandate treatment

54. The Role of Emotions Life and death decisions are highly emotional
Emotional decision making is not necessarily inappropriate and it may be as morally informed as any informed or rational decision
(Janvier. Acta Paed; 2012)
Most big decisions in life are at least partially based on emotions

55. Effect of Decisions on Parents
Typically not part of a prenatal consultation:
How will they deal with the emotional or spiritual consequences of making a decision to withhold life support?
Will they be able to deal with the challenges of raising a child with severe disabilities or special healthcare needs?
Will they themselves, their marriage and their family be strengthened? Or destroyed?

56. Considerations for Prenatal Consultation
Provide general outcome information for parents based on the information available
Explain what is typically done in similar cases at your institution
Describe that process (comfort care, re-evaluation after initial response to DR support, ICU care)
Ask parents if they are comfortable with such an approach with their baby/ babies given the current circumstances
Recognize circumstances change