Ethics in the Delivery Room
C0009 NRP® Current Issues Seminar:
Monumental Changes on the Horizon
Steven Ringer, MD, PhD, FAAP
Henry C. Lee, MD, FAAP
Massachusetts General Hospital Stanford University
(Boston, MA)
(Palo Alto, CA)
Faculty Disclosure Information
In the past 12 months, we have no relevant financial
relationships with the manufacturer(s) of any commercial
product(s) and/or provider(s) of commercial services
discussed in this CME activity.
We do not intend to discuss an unapproved/investigative
use of a commercial product/device in my presentation.
Learning Objectives
• Review NRP Guidelines for Withholding and Discontinuing
Resuscitation
• Become familiar with common scenarios presenting ethical
conflict in neonatal resuscitation
• Understand divergent perspectives for ethical modes of
shared decision-making for:
– preterm neonates in the gray zone of periviable birth
– non-responsive term infant
• Recognize the issues surrounding research during the
newborn period
Case #1
• A woman presents at 23 +4/7 weeks gestation
with preterm labor and cervical dilation.
• She has some uterine tenderness but no other
signs of chorioamnionitis.
• You meet with her and her partner to discuss care
of the fetus / newborn as delivery appears to be
imminent
Case #1
• How do you counsel the family?
• What options do you discuss?
• What else would you like to know?
Case #1
• Periviable birth: executive summary of a joint workshop by the
Eunice Kennedy Shriver NICHD, SMFM, AAP, ACOG.
• Variability across populations and centers
– Antenatal and neonatal practices
– Outcomes
• Importance of communication between obstetric
and neonatal teams
Raju T, Mercer B, Burchfield D, Joseph G. AJOG. 2014; 210(5):406-17.
Case #1
Authors
Time
Survival (%)
22 weeks
Survival (%)
23 weeks
Survival (%)
24 weeks
Survival (%)
25 weeks
Donohue
1993-2001
31
Petrova
1998-2001
40
Tyson
1998-2003
51
Mehler
2000-2007
41
76
82
80
Kyser
2000-2009
33
58
87
Stoll
2003-2007
6
26
55
Lee
2005-2008
5
28
60
72
Case #1
• Obstetric care – should this mother receive / be
offered / not receive:
–
–
–
–
–
Tocolytic therapy?
Antenatal corticosteroids?
Magnesium sulfate for neuroprotection?
Antibiotic treatment?
Cesarean delivery?
Case #1
• Tocolysis / magnesium sulfate / antibiotics –
no studies specifically address preterm labor
at 20-25 weeks GA
• Corticosteroids – observational studies show
benefit for 23 to 25 weeks, but not at 22
weeks. Mortality reduced for all GA
Case #1
• Cesarean delivery –
– Routine?
– In fetal distress?
Case #1
• Components of counseling
– Benefits and risks of obstetric interventions
– Rationale for or against active maternal and
neonatal intevention
– Institutional, regional, or other data on outcomes
– Comfort care as an approach to care
Antenatal Counseling Regarding
Resuscitation and Intensive Care
Before 25 Weeks of Gestation (COFN 2015)
• “wait and see” attitude may not be optimal
– Not accurate in prediction
– Can delay resuscitation
• Attitude of parents
– Statistical information may not be useful for some
families
• ILCOR 2015
• However, in individual cases, when counseling a family and
constructing a prognosis for survival at gestations below 25
weeks, it is reasonable to consider variables such as
perceived accuracy of gestational age assignment, the
presence or absence of chorioamnionitis, and the level of
care available for location of delivery. Decisions about
appropriateness of resuscitation below 25 weeks of
gestation will be influenced by region-specific guidelines.
Case #2
• A mother presents at term gestation with two hours
of decreased fetal movement.
• Rapid ultrasound reveals little movement and a
markedly slow heart rate.
• The patient is taken for immediate cesarean section,
and the infant emerges pale and cyanotic with no
spontaneous movement or breathing.
Case #2
• Resuscitation is begun according to NRP guidelines.
Despite good chest rise with PPV, giving epinephrine,
no heart rate can be palpated or heard, even after 10
minutes of resuscitative efforts.
• Your team is wondering what to do.
Case #2
• Is it reasonable to stop resuscitative efforts?
• What are the possible outcomes?
• Does it matter what type of hospital where
this occurs?
Case #2
• When is resuscitation futile?
– ILCOR 2015
– We suggest that, in infants with an Apgar score of
0 after 10 minutes of resuscitation, if the heart
rate remains undetectable, it may be reasonable
to stop assisted ventilation;
Case #2
• …however, the decision to continue or discontinue
resuscitative efforts must be individualized. Variables
to be considered may include
– whether the resuscitation was considered optimal;
– availability of advanced neonatal care, such as therapeutic
hypothermia;
– Specific circumstances before delivery (eg, known timing
of the insult);
– and wishes expressed by the family
Case #2 - ? Futile ?
• Subgroup analysis of NICHD Cooling trial revealed that
24 % of infants with 10 minute Apgar of 0 were alive
without moderate to severe disability at 18 months,
21% with IQ 77-99 and normal executive, visual and
motor function at 6-7 years
• Sarkar et al reported uniformly poor outcome among
infants treated with head cooling who had 10 minute
Apgar of 0.
Sarkar S, Predicting death despite therapeutic hypothermia in infants with hypoxic-ischaemic
encephalopathy. Arch Dis Child Fetal Neonatal Ed 2010;95:F423–8.
Case #2
• Is 10 minutes enough or too much?
• Kasdorf and coworkers examined recent studies
that included therapeutic hypothermia, and
acquired data for infants without apparent HR
at 10 minutes: 4 RCTs done between 20002009, and local experience
ADC-FNN Online First, published on October 23, 2014 as
10.1136/archdischild-2014-306687
* Mortality or abnormal NDI occurred in 73% of infants treated with hypothermia, and
79% of controls.
* 15/56 (27%) of those treated with hypothermia, and 7/34 (21%) of normothermic
controls were developmentally normal at follow up
* Overall mortality was 50%.
Case #2
• These results, while still limited, are far better
than earlier small studies that antedate
hypothermia:
• Jain published series of 58 infants, all but one of
whom expired
• Haddad reported 16 term and preterm infants, of
whom 14 expired
• Intriguing that both cooled and normothermic
infants did better
Case #2
• Beware the limitations…
– Selected cohort, not all compared with controls
– The most severe cases may not have been offered
hypothermia
– We don’t know how many babies died in delivery
room, and we don’t know details of resuscitation,
or what the HR really was
– Follow-up is limited to 18-24 months
Case #2
• The data suggest that outcomes are improving
• Death in the DR may not be a limitation in that if
resuscitation is impossible there is no survival
with severe disability. There is also the
opportunity to limit care in NICU
• In high level centers, depending on
circumstances, continuing resuscitation may be
correct
Case #2
• How important is HR?
– The primary goal of resuscitation is to establish
ventilation, but…
– the gold standard of assessment is a rise in the
Heart Rate
– Major errors do occur, including not detecting a
HR that is there, or identifying a HR when none is
present
Case #3 - RESEARCH
• Was the SUPPORT trial unethical?
• What could have been done better in regard to
informed consent?
• Were there errors in the judgment of the Office
for Human Research Protection’s assessment?
• In ideal circumstances, what could have been
improved scientifically to allow better
generalizability of results?
SUPPORT
• 23 centers NICHD
• Low vs high oxygen saturation target
– Lower oxygen target  lower risk of ROP
– Higher oxygen target  increased survival
• CPAP vs intubation at birth
SUPPORT
• OHRP – consent forms inadequate due to not
informing of “foreseeable risks”
• New York Times article
• Lawsuit against UAB Hospital – summary
judgment dismissed.
SUPPORT – representative enrollment?
• “Enrollment of extremely low birth weight infants in a clinical
research study may not be representative” Wade Rich et al.
Pediatrics 2012
SUPPORT – representative enrollment?
•
“Enrollment of
extremely low
birth weight
infants in a
clinical research
study may not be
representative”
Wade Rich et al.
Pediatrics 2012
RESEARCH ETHICS
• You would like to design a research study to
test tracheal suctioning for meconium stained
amniotic fluid.
– What is your study design? Randomized - how?
– Who will you enroll?
– Will you obtain informed consent / how?
Changes You May Wish to Make in Practice
1. Work with an interdisciplinary team to develop policies
and procedures to promote consistent yet individualized,
timely, effective counseling for periviable birth.
2. Develop strategies for appropriate practice in
supporting families in providing comfort care to a
neonate when resuscitation is withheld or stopped.
References
For more information on this subject, see the following
publications:
Please refer to handouts.