Infants At Threshold of Viability: Ethical and Clinical Considerations

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Infants At Threshold of Viability Ethical and
Clinical Considerations

• Li Li MD
• Pediatric Resident
• Mubariz Naqvi MD
• Professor of Pediatrics
• Department of Pediatrics
• Texas Tech University HSC at Amarillo

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Abstract

• The birth of an extremely-low-birth-weight
  (ELBW) and gestational age infant pose great
  challenge to the family and the health
  professionals with complex medical, social and
  ethical issues. Increased risks of chronic
  medical problems and disability usually ensue
  after survival. It is difficult to make a
  decision in providing optimal medical care to the
  infant and the family when delivery happens at
  the threshold of viability. An individualized
  prognostic strategy appears to be the most
  appropriate approach. Through a process of
  effective communication between the parents and
  physicians, the goal is to reach a consensual
  decision that respects parents wishes and
  promotes physician beneficence, with the best
  interests of the infant placed in the centre of
  the analysis.

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Case ScenarioMaternal History

• 17 years old, G1, Now P1
• O-positive and antenatal screens negative
• Medications during pregnancy
• Magnesium Sulfate and Celestone
• Denies alcohol, cigarette, and substance abuse.
• History of Evans, Hellp Syndrome, and
  Thrombocytopenia.

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Case ScenarioBH

• Gestational Age of 23 weeks.
• Delivery by C-section due to PIH and
  Thrombocytopernia
• Apgar score
• 1 minute -4
• 5 minutes - 7
• Intubated at delivery room and was given
  surfactant.

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Case ScenarioAdmission P.E.

• Ballard Score 23 weeks
• Weight 466 grams
• Length 25 cm
• Head Circumference 20 cm
• Vital Signs T 98 HR 135 RR 35 BP
  35/23 MAP 27
• Head AFOS bruise on scalp
• Chest/Lung Equal breath sounds
• Cardiovascular No murmurs
• Abdomen Soft and lax.
• Extremities Within normal limit.
• Neuro Appropriate for Gestational Age

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Case Scenario NICU Course -1

• I. Healthcare Maintenance
• NPO
• IVF
• TPN
• Marked Metabolic Imbalance
• Metabolic Acidosis since DOL 3
• Lactic Acid 9mg/dl
• PH 7.1
• Hypoglycemia
• Hypernatremia
• Hyperchloremia
• Hypocalciemia
• Hypophosphatemia

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Case Scenario NICU Course - 2

• Central Nervous System
• Baby had hypotonia, neurosonogram showed grade
  III and IV hemorrhage
• Respiratory System
• RDS
• PIE
• Initially on conventional ventilator
• After PIE, received high-frequency ventilation.

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Case Scenario NICU Course -3

• Cardiovascular System
• Hypotension
• Required dopamine and dobutamine
• GI System
• The baby was kept n.p.o. He did not develop
  issues
• with the GI System

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Case Scenario NICU Course - 4

• Renal System
• This baby developed oligoanuria and renal
  failure gradually. The last BUN was 61 and
  creatinine was 2.8.

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Case Scenario NICU Course - 5

• Hematological System
• Anemia of prematurity. The lowest hemoglobin was
  7.8 on DOL 3. He was transfused.
• Jaundice. The highest bilirubin was 8.3. He
  received phototherapy. The last bilirubin was
  5.8.
• Thrombocytopenia The lowest platelet was 48. He
  received platelet transfusion.

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Case Scenario NICU Course - 6

• Infectious Disease
• The baby was suspected to have sepsis. He was
  started on ampicillin and gentamicin. The blood
  culture came back negative.
• Due to extreme prematurity, the baby was at high
  risk for infection. Antibiotics were continued.

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Case Scenario NICU Course - 7

• Family and ethical concerns
• Both of the parents were actively involved with
  this babys care.
• Prenatal consult was provided. Parents were aware
  of the condition.
• Due to the critical condition of this baby,
  physician and parents conferences were held.
• The parents agreed with the palliative care and
  they signed the DNR on DOL 6.
• Palliative care was provided.
• The patient died at 1645 on 12 February 2008
  while being held by his father and mother.

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Infants At Threshold of ViabilityEthical and
Clinical Considerations

• Objectives
• Outcome of babies at borderline viability.
• Ethical considerations.
• Differences of opinion.
• Counseling of parents.
• Assessment and care at delivery room.
• Limits of continuing care in the NICU.
• The futility of continuing treatments.
• Care after withdrawing ventilatory support.
• Future directions.

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World Health Organization Guidelines for Live
Birth

• Live birth refers to the complete expulsion or
  extraction from the mother of a product of
  conception.
• Irrespective of the duration of pregnancy.
• Breathes or shows signs of beating heart,
  pulsation of the umbilical cord.
• Movements of the voluntarily muscles.
• Whether or not the umbilical cord has been cut or
  the placenta has been separated.
• Each product of such a birth is considered a live
  born.

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Threshold of Viability

• With continual progress in perinatal care, the
  limits of human viability has moved to younger
  gestational age and survival rate has risen.
• Morbidity and mortality is still high for infants
  born between 22 to 25 weeks gestation.
• The threshold of human viability is limited by
  the physiological development of the lungs
  occurring at 22 to 24 weeks of gestation.
• The intact survival is not expected to improve
  with the current technological resources.

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Threshold of Viability

• Borderline viability - Gestational age 21 to 25
  weeks.
• The burden of intensive care.
• Balance between legacy of impairments and
  benefits of survival.
• Threshold of viability in developing countries
  (28 weeks).

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Ethical Issues and Dilemmas

• Care of very preterm infants implies a variety of
  complex medical, social, and economical aspects
  that call for ethical decisions to be made.
• Boundaries between utility and fatality are
  unclear.
• Infants best interest, wishes of the parents, and
  actions of the physicians lead to ethical issues
  and dilemmas in the perinatal and neonatal
  arena.

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Long Term Issues

• The majority of these infants will die before,
  during, and after birth in the NICU.
• Many survivors will die before their first
  birthday.
• Approximately 50 will suffer from moderate to
  severe neuro-developmental problems.
• At 6 years of age some of them will develop some
  kind of learning disability.

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Directives to the Healthcare Teams and Parents

• To help parents and physicians, various forms of
  guidelines have been approved by many universal
  scientific societies.
• According to the Institute of Medicine - clinical
  practice guidelines should be systematically
  developed.
• Statements to assist practitioners and patients
  regarding decisions about appropriate health care
  for specific clinical circumstances should be
  formulated.
• Recommendations should be explicit with
  definitive intent to influence what clinicians
  do.

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Neonatal survival and morbidity by gestational
age and birth weight (NICHD)
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Serious Neonatal Morbidities in Infants at
Threshold of Viability (NICHD)
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Epicure StudyU.K Information (2000)

• Completed Weeks of Gestation

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Definition of Disability Epicure Study

• Severe Disability
• Highly dependent on caregivers. (e.g. unable to
  walk, very low I.Q, profound hearing loss and
  blind.)
• Moderate Disability
• Reasonable level of independence. (e.g. able to
  walk, below average I.Q, correctable hearing loss
  and impaired vision.)
• Mild Disability
• Learning Difficulty and squinting or no
  disability.

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Data from NWTHS NICU 2007

• Total number of infants 32
• which is 1 of live births
• Gender Distribution of mortality
• Female 9/22 Mortality 40
• Male 5/10 Mortality 50
• Follow up information not available.

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Gaps in the Knowledge of Management of Periviable
Infants

• Obstetric Issues
• Evidence based management approach for medical
  and OB complications.
• Identification of sensitive markers for in utero
  therapy.
• Etiology of periviable births.
• Develop tools to treat intra uterine infections.
• Periviable birth survival in relation to gender
  and race.

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Gaps in the Knowledge of Management of
Periviable Infants

• Accurate assessment of gestational age and fetal
  well being.
• Specific prenatal therapy.
• Impact of medical counseling on OB/Neonatal care.
• Identification of prenatal markers for poor
  neonatal outcome.

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Gaps in Neonatal Management

• Acute delivery room therapy.
• Pulmonary and Cardiovascular support.
• Fluid, electrolyte, nutrition, and environmental
  care.
• Post natal growth rates.
• Skin care barrier function and risk of
  infection.
• Infection prevention.
• Brain injury and healing.
• Improvement of long term outcome in relationship
  to chronic medical illness.

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Ethical Considerations Based on the NRP
Guidelines

• The four ethical principles are
• Autonomy Respect individuals rights of freedom
  and liberty to make choices that effect his or
  her life.
• Beneficence - Act so as to benefit others.
• Non-maleficence Avoid harming others
  unjustifiably.
• Justice Treat people truthfully and fairly as
  you want to be treated.

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Ethical ConsiderationsBased on the Best Interest
Concept

• Degree of pain and suffering.
• Whether medical intervention is futile in certain
  circumstances.
• The likelihood of survival free of serious
  disability.
• The impact on the family, should there be a
  legacy of serious disability.

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Best Interest of the Infant

• Based on perception of others, parents and/or
  medical staff.
• The variable outcome of these infants colors the
  perception of parents and healthcare teams.
• We may be guided by data on average survival and
  risk of disability among survivors.
• No reliable markers or outcome for individual
  infants are available at the time of decision
  making shortly before or at birth.

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Role of Informative Counseling Before Delivery

• To provide parents with information regarding
  chance of survival.
• To inform parents regarding immediate neonatal
  problems.
• Parents should also be informed regarding chronic
  medical problems such as BPD, ROP, and IVH.
• Information regarding long-term neurological and
  psychological problems should be offered.
• Combined Counseling with OB, neonatologist, and
  nursing stuff is prudent.

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Assessment and Care in the Delivery Room

• Careful assessment at birth by an experienced
  neonatologist/nursing staff.
• Confirm signs of life.
• Assessment of gestational age and formation of
  opinion whether OB gestational age matches with
  the physical assessment.
• To assess the physical condition including vital
  signs and presence of lethal malformations and
  anomalies.
• To decide whether any medical intervention is
  appropriate and according to the discussion with
  parents during the antenatal counseling.

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Assessment and Care in the Delivery Room

• The infant who is viable should be stabilized
  using the NRP guidelines.
• If there is a positive response, the infant
  should be transferred to the NICU for further
  care.
• NICU management should be evidence based.
• Frequent communications should be held between
  parents and the medical staff.

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Limits of Continuing Care in the NICU

• Great risk of developing wide range of neonatal
  complications.
• Temptation for younger clinical staff to see each
  complication a challenge to be met at all costs
  simply because the baby is a patient in the NICU.
• In contrast, NICU should be seen as providing a
  supportive role to parents while the baby is
  undergoing a trial of life.

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Futility of Continuing Treatment

• Aggressive treatment at times becomes futile
• Multiple organ failure.
• No signs of improvement.
• Conditions steadily deteriorating.
• Massive intracranial hemorrhage.

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Preparation for Palliative Care

• Inform the parents what the process normally
  entails.
• Give them the opportunity to contribute to their
  babys care.
• Help them understand that following extubation a
  variable length of time will elapse before their
  baby will die.

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Care After Withdrawing Ventilatory Support

• An optimal environment should be provided.
• Surroundings should be compassionate.
• Staff should be non-judgmental and consistent.
• Time should be provided to create memories,
  allowing parents to dress, diaper, bath, feed,
  hold in their arms, and take pictures of their
  baby.
• Skin care should be maintained. Medication for
  pain relief and discomfort may be used.
• Spiritual, religious and cultural values should
  receive considerations.

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Summary of Recommendations for the Resuscitation
at Birth. (U.K guidelines) (2008)
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American Academy of Pediatrics Guidelines (2008)
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International Liason Committee on Resusitation
(ILCOR)
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Care of Parents After Babys Death

• Showing kindness and compassion is a must.
• Walk the parents to their transport vehicle.
• This will prevent the feeling of leaving alone.
• They should be given a memory box.
• This will avoid walking out with empty hands.

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Memory Box
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Summary

• Survival rate for very preterm infants has
  improved over the last two decades.
• Infants born at the threshold of viability
  present a variety of complex medical, social, and
  ethical issues.
• Although the incidence of such births is about
  2, the impact on these infants, their families,
  the healthcare providers, and society is
  profound.
• Parents, obstetricians, neonatologists, and
  nurses have to deal with these difficult
  scenarios.
• Many difficult medical and ethical decisions have
  to be made, which leave life long impressions on
  those involved.

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References/Bibliography

• Infants of borderline viability Ethical and
  clinical considerations Malcolm Chiswick Seminars
  in Fetal Neonatal Medicine (2008) 13, 8-15
• Higgins RD, Delivoria-Papadopoulos M, Raju TNK.
  Executive summary of the workshop on the border
  of viability. Pediatrics 20051151392-6.
• Hansen BM, Greisen G. Preterm delivery and
  calculation of survival rate below 28 weeks of
  gestation. Acta Paediatr 200392 1335-8.
• Larroque B, Breart G, Kaminski M, et al.
  Survival of very preterm infants Epipage, a
  population based cohort study. Arch Dis Child
  Fetal Neonatal Ed 200489F139-44.
• Field D, Petersen S, Clarke M, Draper ES.
  Extreme prematurity in the UK and Denmark
  population differences in viability.
• Arch Dis Child Fetal Neonatal Ed 200287172-5.
• Costeloe K, Hennessy E, Gibson AT, Marlow N,
  Wilkinson AR. EPICure Study Group. The EPICure
  Study outcomes to discharge fromhospital for
  infants born at the threshold of viability.
  Pediatrics 200010665-71.
• Marlow N, Wolke D, Bracewell MA, Samara M.
  EPICure Study Group. Neurologic and developmental
  disability at six years
• of age after extremely preterm birth. N Engl J
  Med 2005 3529-19.
• Nuffield Council on Bioethics. Dilemmas in
  current practice babies born at the borderline
  of viability. Critical Care Decisions in Fetal
  and Neonatal Medicine Ethical Issues. November
  2006, p. 67-87.
• Tommiska V, Heinonen K, Lehtonen L, et al. No
  improvement in outcome of nationwide low birth
  weight infant populations between 1996e1997 and
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• Marlow N. Outcome following extremely preterm
  birth. Curr Obstet Gynecol 200616141-6.

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Acknowledgments

• Christopher Thomas Sheehan
• Jan Rice Medical Librarian

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Professionalism Through Reflection

• Few months ago we had the privilege to take care
  of a baby at the threshold of viability. After
  initial response to therapy the immature organs
  started failing. Palliative care was offered and
  was accepted by the family. The small NICU room
  started filling with women and sturdy ranch
  hands. With tears in their eyes and their hats
  held to their chests, with their heads bowed in
  prayer lead by their pastor from Hartley. To them
  he was Yusau, the son of young parents, Jose and
  Maria. To us, he was a micro-premie.
• Happenings in The NICU, Amarillo, Texas.

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We mourn the withering away of flower buds which
were plucked before they could blossom
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• Thank you for your time and attention.