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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
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
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.
Primary studies on physiology of transition and effect of depression
Investigations on best approaches
Evolution of educational modalities
Potential future changes
Expansion to all newbornsTen Key Papers
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 madeEvidenced Based Process
Step 1: Define existing and proposed guidelines
Step 2A: Gather the Evidence
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)
Step 2c: Evaluate the Quality of Evidence
denotes key article(s)
denotes key article(s)
Copy and Paste Summary Table from Worksheet
Some harm was noticed when parachutes failed to open (NNH= 1)Consensus on Science statements
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 harmfulClinical Interpretationof Classes of Recommendation
Newer system is more direct and clear than the previously used classes of recommendation:
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
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) 61. Physiologic effect of asphyxia
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 neededPhysiologic responseto asphyxia
Demonstrated the development of bradycardia and hypotension over course of experiment, recovery with resuscitation
Defined the relationship between length of asphyxia and time for recoveryPhysiologic responseto asphyxia
Adamsons, et al
on length of asphyxia
Adamsons, et al
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 neededPhysiologic responseto asphyxia
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 12. Management of MeconiumStained Fluid (MSF)
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 13. Management of MeconiumStained Fluid (MSF)
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 24. Room Air or 100% 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?
Vento et al., Biol Neonate, 2001
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 oxygen100% Oxygen vsAir: Human Studies
“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
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 differences5. 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.
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 25. Room Air or Oxygen in Prematures?
Wang et al, 2008
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% oxygen6. CPAP for Resuscitation
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 otherCPAP for resuscitation
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 1-26. CPAP for Resuscitation
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 17. Moving beyond Gestational age for prognosis
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 NRP8.Simulation training/Debriefing
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
• 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 prioritiesTraditional learning environments not ideal
• 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 trainingSimulation-Advantages
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 NRPSimulation/Debriefing
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 19. Hypothermia for Asphyxia
Only 2 randomized studies, 50 infants
No adverse effects; no significant therapeutic effects
No recommendation for or against
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 method9. Hypothermia for Asphyxia
See NICHD Workshop: J Peds 2006; 148:170-5
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
Shankaran (NICHD Network), NEJM, 2004
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
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 well10. International efforts
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
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
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
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
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