Ethics in the Delivery RoomC0009 NRP® Current Issues Seminar: Monumental Changes on the HorizonSteven Ringer, MD, PhD, FAAP Henry C. Lee, MD, FAAPMassachusetts 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 #1Authors Time Survival (%)

22 weeksSurvival (%)

23 weeksSurvival (%)

24 weeksSurvival (%)

25 weeksDonohue 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 72

Lee 2005-2008 5 28 60

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 2000-2009, 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.

ReferencesFor more information on this subject, see the following publications:Please refer to handouts.