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Session Information Session Title : NRP: Climbing the Olympic Hill to Better Evidence, Implementation, and Outcomes TEN KEY PAPERS Session Number : C6000 Faculty Name : Steven Ringer, MD, PhD Jay Goldsmith MD George Little MD

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slide1

Session Information

Session Title: NRP: Climbing the Olympic Hill

to Better Evidence, Implementation,

and Outcomes TEN KEY PAPERS

Session Number: C6000

Faculty Name: Steven Ringer, MD, PhD Jay Goldsmith MD George Little MD

Faculty Institutions: Harvard Medical School, Tulane University, Dartmouth Hitchcock Medical Center

slide2

Faculty Disclosure Information

In the past 12 months, we have had no financial relationships with the manufacturer(s) of any commercial product(s) and/or provider(s) of commercial service(s) discussed in this CME activity:

we do not intend to discuss an unapproved/investigative use of a commercial product/device in my presentation.

ten key papers
Key papers on newborn resuscitation, spanning 50 years

Primary studies on physiology of transition and effect of depression

Investigations on best approaches

Evolution of educational modalities

Potential future changes

Expansion to all newborns

Ten Key Papers
evidenced based process
Problem or intervention is defined

A hypothesis is stated

Evidence is sought using numerous search engines i.e. Pubmed, Embase, ECC library etc

Evidence includes both human and animal data (distinguishes this process from Cochrane)

8 levels of evidence

Evidence is evaluated for quality and then placed in grids either supporting or opposing the question

The data are summarized and a scientific statement with a class of recommendation is made

Evidenced Based Process
review and debate of literature
Review and Debate of Literature

Step 1: Define existing and proposed guidelines

Step 2A: Gather the Evidence

review and debate of literature6
Review and Debate of Literature

Step 2b: Classify the Level of Evidence

Level 1: Randomized controlled trial with large effect

Level 2: Randomized controlled trial with small effect

Level 3: Prospective controlled non-randomized study

Level 4: Historic, non-randomized cohort study

Level 5: Non-controlled case series

Level 6 Animal or mechanical model study

Level 7: Extrapolation or theoretical analysis

Level 8: Rational conjecture (common practice)

review and debate of literature7
Review and Debate of Literature

Step 2b: Classify the Level of Evidence

review and debate of literature8
Review and Debate of Literature

Step 2b: Classify the Level of Evidence

review and debate of literature9
Review and Debate of Literature

Step 2c: Evaluate the Quality of Evidence

slide10

Neutral evidence table

denotes key article(s)

slide11

Opposing evidence table

denotes key article(s)

summary outcomes example
Summary Outcomes (example)

Copy and Paste Summary Table from Worksheet

consensus on science statements
Insert Summary statement(s) from worksheet(eg. Evidence from 3 observational studies and 7 animal studies confirm consistent benefits for Parachutes over Handkerchiefs when assessing the following outcome variables: . . .)

Some harm was noticed when parachutes failed to open (NNH= 1)

Consensus on Science statements
draft treatment recommendations
Insert Treatment Recommendations from worksheet

e.g..

Parachutes should be used in all planned and unplanned jumps from altitude.

Handkerchiefs should not be used in jumps from altitude

Draft Treatment Recommendations
knowledge gaps e g ett vs bvm
Other specific worksheets that would be helpful

Relationship with training to ETT success

Specific research required

Adult ETT vs. BVM

Knowledge Gaps (e.g.. ETT vs. BVM)
clinical interpretation of classes of recommendation
Class 1: Always acceptable, proven safe, definitely useful

Class IIa: Acceptable, safe, useful (standard of care intervention of choice)

Class IIb: Acceptable, safe, useful (within the standard of care or an optional or alternative intervention)

Class Indeterminate: Preliminary research stage with promising results but insufficient available evidence to support a final class decision

Class III: Unacceptable, no documented benefit, may be harmful

Clinical Interpretationof Classes of Recommendation

Newer system is more direct and clear than the previously used classes of recommendation:

session goals
Review a central group of papers that impact how we care for newborns now (How and why we do)

Consider recent results that may guide practice in the future (What will we be doing)

Examine the papers advocating a change in education and training for resuscitation (How we teach)

Session Goals
1 physiologic effect of asphyxia
Adamsons K Jr, Behrman R, Dawes GS, Dawkins MJ, James LS, Ross BB. The Treatment of acidosis with alkali and glucose during asphyxia in foetal rhesus monkeys. J Physiol. 1963 Dec;169:679-89

A review of the early work by Dawes, Adamsons and others examining the effects of experimental acute asphyxia on newborn Rhesus monkeys.

Central paper demonstrating physiologic response, primary and secondary apnea, effectiveness of resuscitation

Level of Evidence (LOE) 6

1. Physiologic effect of asphyxia
physiologic response to asphyxia
Rhesus monkeys delivered at term by cesarean section

Controlled Asphyxiation by slipping saline filled rubber bag over head, tying umbilical cord, for 10-15 minutes

Placed on table at 30 degrees C.

Umbilical artery catheterized, infant monitored

Resuscitation with PPV, Oxygen, Cardiac massage as needed

Physiologic responseto asphyxia
physiologic response to asphyxia21
Identified pattern of initial gasping, primary apnea, gasping followed by “last gasp” and secondary apnea

Demonstrated the development of bradycardia and hypotension over course of experiment, recovery with resuscitation

Defined the relationship between length of asphyxia and time for recovery

Physiologic responseto asphyxia
recovery from asphyxia
Recovery from asphyxia

Time for

recovery depends

on length of asphyxia

Adamsons, et al

physiologic response to asphyxia24
These and related papers defined the response of the newborn to acute asphyxia, and set the stage for techniques of resuscitation in humans

Demonstrated the resuscitation before the “last gasp” (~8.4 minutes) resulted in absent or trivial cerebral damage

Resuscitation after 12.5 minutes accompanied by widespread and severe damage

Asphyxia does not end with ventilation, continued support and ongoing evaluation needed

Physiologic responseto asphyxia
2 management of meconium stained fluid msf
Wiswell TE, Gannon CM, Jacob J, Goldsmith L, Szyld E, Weiss K, Schutzman D, Cleary GM, Filipov P, Kurlat I, Caballero CL, Abassi S, Sprague D, Oltorf C,Padula M. Delivery room management of the apparently vigorous meconium-stained neonate: results of the multicenter, international collaborative trial. Pediatrics. 2000;105:1-7

The management of the baby with MSF has evolved dramatically over past 30 years. Most babies not depressed

Randomized MCT of > 2000 babies compared intubation vs. expectant care

Demonstrated lack of utility of intubation and suctioning in vigorous infants with MSF

LOE 1

2. Management of MeconiumStained Fluid (MSF)
3 management of meconium stained fluid msf
Vain NE, Szyld EG, Prudent LM, Wiswell TE, Aguilar AM, Vivas NI. Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: multicentre, randomised controlled trial. Lancet. 2004;364(9434):597-602.

Naso or oropharyngeal suctioning of MSF before delivery of shoulders compared with no suctioning, randomized trial, >2500 infants.

No differences in Meconium Aspiration syndrome, need for ventilation, mortality or length of care

Routine suctioning not recommended

LOE 1

3. Management of MeconiumStained Fluid (MSF)
4 room air or 100 oxygen
Saugstad OD, Rootwelt T, Aalen O. Resuscitation of asphyxiated newborn infants with room air or oxygen: an international controlled trial: the Resair 2 study. Pediatrics. 1998;102(1):e1.

ResAir 2 was the second of two large trials, with >600 babies enrolled, randomized to 100% Oxygen or air

Study demonstrates efficacy of room air resuscitation in a full term cohort, with equal or better safety

LOE 2

4. Room Air or 100% Oxygen
room air or 100 oxygen
No difference in mortality 12.1% RA vs. 15% oxygen

Death within 7 days or moderate/severe hypoxic ischemic encephalopathy: 21.2% RA vs. 23.1% oxygen (NS)

No difference in growth or neurologic disability at 18-24 mo. (only 70% of population)

Cochrane Review concludes there is insufficient evidence to recommend one or the other (Lancet meta-analysis with different conclusion)

Room Air or100% Oxygen?
slide30

Time Needed for Onset of Sustained Respirations

Vento et al., Biol Neonate, 2001

100 oxygen vs air human studies
Meta-analysis of 5 human studies (2004)

Relative risk of death favored RA group

OR 0.71; 95% CI 0.54-0.94

Only 1302 infants included in analysis

No infants <1000 grams; few prematures

? Truly asphyxiated (entry criteria questioned)

Randomization not optimal

Only 2 studies were blinded

168 of 635 infants in RA group received cross-over oxygen

100% Oxygen vsAir: Human Studies
100 oxygen vs air human studies33
Meta-analysis of 5 human studies (2004)

174 of 177 deaths in developing countries

No details of causes of death

No plausible mechanism for deaths in oxygen group proposed

Entry criteria may not have selected babies who were truly asphyxiated

100% Oxygen vs. Air: Human Studies
meta analyses of key human studies
Tan A, Schulze A, O’Donnell CPF, Davis PG: Cochrane Library, Issue 3, 2004

“There is insufficient evidence at present on which to recommend a policy of using room air over 100% oxygen, or vice versa, …”

“We note the use of back-up 100% oxygen in more that a quarter of infants randomised to room air.”

Davis PG, Tan A, O’Donnell CPF, Schulze A: Lancet 364:2004

“The pooled analysis showed a significant mortality benefit for infants resuscitated with air (RR 0.71 [95% CI 0.54-0.94]; RD – 0.05).” Causes of death were not given. Most babies in all 5 studies were recruited from developing countries.

“For term and near term infants, air should be used initially, with oxygen as back-up if initial resuscitation fails”

Meta-Analyses ofKey Human Studies
5 room air or oxygen in prematures
Risk of oxygen toxicity increased in premature infants, prompting RA or low O2 resuscitation

Randomized trial of infants ≤ 28 weeks- starting with low (30%) or high (90%) O2

Weaned up for bradycardia, down for high saturations

Both groups ended up in 45% oxygen, no short term differences

5. Room Air or Oxygen in Prematures?

Escrig R, Arruza L, Izquierdo I, et al. Achievement of Targeted Saturation Values in Extremely Low Gestational Age Neonates Resuscitated With Low or High Oxygen Concentrations: A Prospective, Randomized Trial. Pediatrics 2008; 121: 875-80.

5 room air or oxygen in prematures38
Wang CL, Anderson C, Leone TA, Rich W, Govindaswami B, Finer NN. Resuscitation of preterm neonates by using room air or 100% oxygen. Pediatrics 2008;121(6):1257.

Small trial (41 infants) of RA vs. 100% oxygen as initial gas for infants 23-32 weeks

Weaned up for low saturation, and to 100% for low HR or chest compressions, down for high saturation

All RA patients required rescue, failed to meet target saturations without O2, so RA not recommended

LOE 2

5. Room Air or Oxygen in Prematures?
6 cpap for resuscitation
Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB. Nasal CPAP or Intubation at Birth for Very Preterm Infants. N Engl J Med 2008; 358:700.

Randomized 610 infants 25-28.6 weeks gestation to CPAP+8 or intubation @ 5 min, multicenter

Babies deemed to need immediate intubation were excluded

Infants given mask ventilation at birth if needed, assessed at 5 minutes for need for ongoing support

CPAP by nasal prongs at 8 cm H20

CPAP infants intubated for: Unresponsive apnea, respiratory acidosis or unresponsive metabolic acidosis, need for >60% oxygen

6. CPAP for Resuscitation
cpap for resuscitation
46% of CPAP group were intubated , median time 6.6 hours

33.7% of CPAP group had BPD or died, vs.38.9% of intubated group, not significant

Lower risk of oxygen need or death @ 28 d, no difference in mortality, fewer vent. days

9% pneumothorax in CPAP group, vs. 3 % in other

CPAP for resuscitation
6 cpap for resuscitation42
CPAP did not reduce death or BPD in 25-28 week gestation infants

Did result in less oxygen use at 28 days, but more pneumothoraces, no difference in associated morbidities

Results suggest that starting with CPAP is appropriate, and that not all small babies need surfactant

CPAP used at 8 cm H2O, not started until 5 minutes, so less easy to generalize

LOE 1-2

6. CPAP for Resuscitation
7 moving beyond gestational age for prognosis
Tyson JE, Parikh NA, Langer J, Green C, Higgins RD. Intensive Care for Extreme Prematurity- Moving beyond Gestational Age. NEJM 2008; 358:1672

Outcome evaluated in over 4100 ELBW infants

Death or degree of impairment evaluated

Not only Gestational age, but sex, exposure to antenatal steroids, singleton or multiple, birthweight have impact

LOE 1

7. Moving beyond Gestational age for prognosis
8 simulation training debriefing
Ohlinger J, Kantak A, Lavin JP Jr, Fofah O, Hagen E, Suresh G, Halamek LP,Schriefer JA.Evaluation and development of potentially better practices for perinatal and neonatal communication and collaboration. Pediatrics. 2006;118 Suppl 2:S147-52.

Halamek LP. The simulated delivery-room environment as the future modality for acquiring and maintaining skills in fetal and neonatal resuscitation. Semin Fetal Neonatal Med. 2008; (Jun)2.

Simulation training has increased in sophistication over the past several years

Effective simulation does not require high technology, but a commitment to “suspend disbelief” and work as a team

The use of simulation in team teaching and training is becoming the standard, is the future for NRP

8.Simulation training/Debriefing
8 simulation training debriefing45
Delivery of optimum care requires more than just assimilation of content knowledge and proficiency in technical skills

Skills needed include:

Cognitive, or content knowledge “think”

Technical, or manual skills “do”

Behavioral “think and do, as part of a team”

8.Simulation training/Debriefing
behavioral skills
1. Know your environment.

2. Anticipate and plan.

3. Assume the leadership role.

4. Communicate effectively.

5. Delegate workload optimally.

6. Allocate attention wisely.

7. Use all available information.

8. Use all available resources.

9. Call for help when needed.

10. Maintain professional behavior.

Behavioral skills
traditional learning environments not ideal
• Classroom environment

• Characterized primarily by passive, not active, learning opportunities

• May be primarily focused on teaching rather than learning

• Lacks realistic cues, distracters and pressures

• Unable to adequately prepare for practice in the real environment

• Clinical environment

• Places patients at some degree of risk

• Learning opportunities (cases) present randomly

• Learning limited by fast pace, production pressure, inherent high cost and other competing priorities

Traditional learning environments not ideal
simulation based training
Highly realistic scenarios and environment

Allow learners to work through clinical challenges as best they can, then “debrief”

Learners must “suspend disbelief ”

Self reflection is key component

Simulation basedtraining
simulation advantages
• Creates no risk to human patients

• Provides structured learning opportunities with defined learning objectives

• Allows practice without interruption/interference

• Can be scheduled at times convenient to trainees and instructors

• Easily tailored to the needs of individual trainees

Can be scaled in intensity to meet the needs of learners at all levels of experience

• Allows practice of routine and rare situations

• Fosters integration of cognitive, technical and behavioral skills

• Facilitates multidisciplinary team training

Simulation-Advantages
simulation and nrp
Is becoming the standard for teaching/learning

It isn't the sophistication of the equipment, but how it is used

As behavior is better understood, techniques and value of simulation will increase

Simulation and NRP
simulation debriefing
Simulation is effective for teaching, but only when coupled to debriefing sessions

The construct of these sessions is critical to success

These papers will provide insight and a preview of simulation training as a standard part of NRP

Simulation/Debriefing
9 hypothermia for asphyxia
Jacobs S, Hunt R, Tarnow-Mordi W, Inder T, Davis P. Cooling for newborns with hypoxic ischaemic encephalopathy. CochraneDatabase Syst Rev. 2007 Oct 17;(4):CD003311

Hypothesis: Selective and/or whole body modest hypothermia implemented in the first six hours of postnatal life in term infants at highest risk for evolving to moderate to severe encephalopathy will reduce the subsequent development of irreversible brain injury without untoward side effects.

Meta-analysis of 8 randomized trials of hypothermia to treat asphyxia and prevent brain injury

Evidence shows benefit in reduction of mortality and morbidity in term infants

LOE 1

9. Hypothermia for Asphyxia
9 hypothermia for asphyxia53
Re-analysis of 2003 review:

Only 2 randomized studies, 50 infants

No adverse effects; no significant therapeutic effects

No recommendation for or against

2007 meta-analysis:

8 randomized studies, 638 term infants

↓ in death and ND disability in cooled patients

↑ need for inotropic support and ↓ platelets

Conclusion: Cooling reduces mortality without increasing major disability to survivors

Further trials needed to determine appropriate method

9. Hypothermia for Asphyxia
slide54

Neonatal Post-AsphyxiaHypothermia RandomizedControl Trials

See NICHD Workshop: J Peds 2006; 148:170-5

slide55
For infants with moderate

encephalopathy

(aEEG determined)

more cooled versus control infants had a favorable outcome (52% versus 34%; p=0.02) and were less likely to be severely affected (11% versus 28% p=0.03).

There was no effect in infants with severe encephalopathy and/or with seizures upon presentation.

“Cool Cap” Study

Gluckman et al Lancet 2005

slide56

Whole body cooling

Shankaran (NICHD Network), NEJM, 2004

9 hypothermia for asphyxia issues
What severity of insult defines appropriate risk-benefit ratio? EEG? aEEG? Seizures?

What is the appropriate timing – Duration? When is too late?

Risk-benefit for preterm? IUGR?

Whole body vs. selective head? Appropriate method of re-warming?

9. Hypothermia for Asphyxia: Issues
10 international efforts
Singhal N, Niermeyer S. Neonatal resuscitation where resources are limited. Clin Perinatol. 2006;33(1):219-28.

NRP has been used increasingly in the developing world over the past several years

While the basic principles are the same, the practice requires adaptation in resource-poor environments and specialized programs are under development

Often lessons learned in these settings have value in the developed world as well

10. International efforts
references and papers for discussion
Adamsons K Jr, Behrman R, Dawes GS, Dawkins MJ, James LS, Ross BB. The Treatment of acidosis with alkali and glucose during asphyxia in foetal rhesus monkeys. J Physiol. 1963 Dec;169:679-89

Wiswell TE, Gannon CM, Jacob J, Goldsmith L, Szyld E, Weiss K, Schutzman D, Cleary GM, Filipov P, Kurlat I, Caballero CL, Abassi S, Sprague D, Oltorf C,Padula M. Delivery room management of the apparently vigorous meconium-stained neonate: results of the multicenter, international collaborative trial. Pediatrics. 2000;105:1-7

Vain NE, Szyld EG, Prudent LM, Wiswell TE, Aguilar AM, Vivas NI. Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: multicentre, randomised controlled trial. Lancet. 2004;364(9434):597-602.

References and papers for discussion
references and papers for discussion60
Saugstad OD, Rootwelt T, Aalen O. Resuscitation of asphyxiated newborn infants with room air or oxygen: an international controlled trial: the Resair 2 study. Pediatrics. 1998;102(1):e1.

Saugstad OD, Ramji S, Irani SF, El-Meneza S, Hernandez EA, Vento M, Talvik T, Solberg R, Rootwelt T, Aalen OO. Resuscitation of newborn infants with 21% or 100% oxygen: follow-up at 18 to 24 months. Pediatrics. 2003;112(2):296-300.

Tan A, Schulze A, O’Donnell CP, Davis PG. Air versus oxygen for resuscitation of infants at birth. Cochrane Database Syst Rev. 2005;(2):CD002273.

References and papers for discussion
references and papers for discussion61
Wang CL, Anderson C, Leone TA, Rich W, Govindaswami B, Finer NN. Resuscitation of preterm neonates by using room air or 100% oxygen. Pediatrics 2008;121(6):1257.

Escrig R, Arruza L, Izquierdo I, Villar G, Saenz P, Gimeno A, Moro M, Vento M. Achievement of targeted saturation values in extremely low gestational age neonates resuscitated with low or high oxygen concentrations: a prospective, randomized trial. Pediatrics. 2008;121(5):875-81

Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB. Nasal CPAP or Intubation at Birth for Very Preterm Infants. N Engl J Med 2008; 358:700.

References and papers for discussion
references and papers for discussion62
Tyson JE, Parikh NA, Langer J, Green C, Higgins RD. Intensive Care for Extreme Prematurity- Moving beyond Gestational Age. NEJM 2008; 358:1672

Ohlinger J, Kantak A, Lavin JP Jr, Fofah O, Hagen E, Suresh G, Halamek LP,Schriefer JA. Evaluation and development of potentially better practices for perinatal and neonatal communication and collaboration. Pediatrics. 2006;118 Suppl 2:S147-52.

Halamek LP. The simulated delivery-room environment as the future modality for acquiring and maintaining skills in fetal and neonatal resuscitation. Semin Fetal Neonatal Med. 2008; (Jun)2.

References and papers for discussion
references and papers for discussion63
Falcone RA Jr, Daugherty M, Schweer L, Patterson M, Brown RL, Garcia VF. Multidisciplinary pediatric trauma team training using high-fidelity trauma simulation. J Pediatr Surg. 2008;43(6):1065

Jacobs S, Hunt R, Tarnow-Mordi W, Inder T, Davis P. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003311

Singhal N, Niermeyer S. Neonatal resuscitation where resources are limited. Clin Perinatol. 2006;33(1):219-28.

References and papers for discussion