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Selective Head Cooling for Acute Hypoxic Ischemic Encephalopathy

Selective Head Cooling for Acute Hypoxic Ischemic Encephalopathy. Caroline O. Chua, MD Chief, Neonatal Fellow Regional NICU Maria Fareri Children’s Hospital at Westchester Medical Center. Lance A. Parton, MD Associate Director Regional NICU Maria Fareri Children’s Hospital at

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Selective Head Cooling for Acute Hypoxic Ischemic Encephalopathy

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  1. Selective Head Cooling for Acute Hypoxic Ischemic Encephalopathy Caroline O. Chua, MD Chief, Neonatal Fellow Regional NICU Maria Fareri Children’s Hospital at Westchester Medical Center Lance A. Parton, MD Associate Director Regional NICU Maria Fareri Children’s Hospital at Westchester Medical Center

  2. Hypoxic Ischemic Encephalopathy • One of the leading causes of severe long-term neurologic deficits in infants and children (cerebral palsy) • Incidence of 2-3 per 1,000 term live births • Etiologies: abruptio (25%), uterine rupture, prepartum hemorrhage, dystocia, prolapsed cord, placental insufficiency, twins, extramural deliveries • Mortality is 15-20% >25% of survivors have permanent disabilities

  3. HYPOXIA - ISCHEMIA Anaerobic Glycolysis ATP Adenosine Lactate Glutamate Hypothermia NMDA Receptor NMDA receptor blocker Hypoxanthine Intracellular Ca+ Ca+ channel blocker Xanthine oxidase inhibitors Activates NOS Activates Lipases Activates proteases Activates nuclease Cyclooxygenase inhibitors Xanthine NO O2 Free Fatty Acids Disruption of cytoskeleton Damage to DNA Superoxide radicals O2 Free Radicals Free radical scavengers Free Radicals Free Radicals NEURONAL CELL DEATH

  4. Foundation Fact • The ability to identify infants at highest risk for progressing to HIE is critical Hypoxia Ischemia Injury No Injury Resolve Primary Energy Failure Secondary Energy Failure Resolve Injury Latent phase Potential Therapeutic Window

  5. Hypothermic Treatment of HIE • 2 phases to injury • Initial insult at birth • Secondary failure starts within 6-24 hours of birth • Therapeutic window of 6 hours

  6. Head Cooling: How It Works • Reduces cellular metabolic demands, delaying depolarization • Reduces release of excitatory amino acids (e.g. glutamate) and free radicals • Reduces intracellular reactions of excitatory amino acids • Reduces release of pro-inflammatory cytokines, microglial activation, and neutrophil recruitment. • Suppression of apoptotic biochemical pathways (e.g. caspase activity).

  7. Selective Head Cooling • Technique • Head is fitted with cooling cap • Body is warmed with radiant warmer • Advantages • Brain is cooler than the rest of the body • Fewer side effects

  8. Cool-Cap Trial • Randomized, controlled, masked, multi-center (25), international trial (n=234) • Protocol: • Standard of care or rectal temp of 34 to 35C for 72 hours using cool cap • Passively rewarmed for 4 h (at ~0.5C/h) • Primary end point: death or severe neurodevelopmental disability at 18 months • Confirmed Cool-Cap System is Effective & Safe Gluckman et al. Lancet. 2005; 365:663-670

  9. Cool-Cap Trial Findings – Efficacy • Statistically significant treatment effect for moderately abnormal aEEG (p = 0.04) • Moderate encephalopathy: 1 out of 6 is shifted from unfavorable to favorable outcome • Severe encephalopathy: no effect on death and severe disability Gluckman et al. Lancet. 2005; 365:663-670

  10. Cool-Cap Trial Findings – Safety • No statistical difference in mortality @ 18 mos • 33% (36/108) cooled vs. 38% (42/110) control • No difference in rates of any Serious Adverse Events • Scalp edema in some – resolved quickly • Conclusion – Cooling is safe when the Cool-Cap clinical trial protocol is followed Gluckman et al. Lancet. 2005; 365:663-670

  11. Predictive Calculations of Efficacy for Hypothermia to treat Neonatal HIEPerlman and Shah, 2008 • 15-18 babies are born daily in the U.S. with moderate to severe HIE • 10-12, of the above, die or develop moderate to severe disability • Hypothermia to all 15-18 babies would prevent 3 from death or moderate to severe disability without any significant adverse effects

  12. Selecting Infants for Treatment Indications For Use • The Olympic Cool-Cap System is indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE) • as defined by criteria A, B and C • The Cool-Cap System provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurological injury associated with HIE * Cool as early as possible and within 6 hours of birth

  13. Criteria A Infant at ≥ 36w gestational age and at least one of the following • Apgar score ≤ 5 at 10 min • Continued need for resuscitation, including endotracheal or mask ventilation, at 10 min after birth • Acidosis defined as either umbilical cord pH or any arterial pH <7.00 within 60 min of birth • Base deficit ≥ 16 mmol/L in umbilical cord blood sample or any blood sample within 60 min of birth (arterial or venous blood)

  14. Criteria B Infant with moderate to severe encephalopathy consisting of altered state of consciousness (as shown by lethargy, stupor, or coma) and at least one of the following • Hypotonia • Abnormal reflexes, including oculomotor or pupillary abnormalities • Absent or weak suck • Clinical seizures

  15. Criteria C Infant has an amplitude-integrated encephalogram / cerebral function monitor (aEEG/CFM) recording of at least 20 minutes duration that shows either moderately/severely abnormal aEEG background activity or seizures * Use Olympic CFM 6000

  16. Contraindications • Imperforate anus • Evidence of head trauma or skull fracture causing major intracranial hemorrhage • Birth weight < 1,800g

  17. Practical Tips for NBN/NICUsTransferring Newborns for Cooling • Educate staff, especially “off-hours” personnel to recognize eligibility for cooling • Provide cardiorespiratory stability • Avoid hyperthermia • Turn off radiant warmer • Maintain Rectal Temperature: 34 - 35 C • IV Glucose, ASAP

  18. Practical Tips for NBN/NICUsTransferring Newborns for Cooling • Cord Gas/ ABG/ VBG; birth weight and head circumference • Use double lumen UV lines (preferably) • Initiate transport • Call WMC-Transport team ASAP 866 - WMC PEDS or 866 – 468 - 6962 • Don’t wait for lines, images, labs • Discuss cooling but make no promises regarding: use of cooling and outcome

  19. Possible Brain Insult At Birth? Cool Cap® Monitor Cool Cap ® in Place Call (24/7): (866) WMC-PEDS MFCH is the only NICU in the Hudson Valley Employing the Head-Cooling Cool Cap® for patients who may have Perinatal Asphyxia

  20. Extra Corporeal Membrane Oxygenation Maria Fareri Children’s Hospital E C M O Call (24/7): (866) WMC-PEDS or (866) 468-6962 Newborn Infant Child Young Adult

  21. Extra Corporeal Membrane Oxygenation Heart-LungBypass Consider for the Following Conditions: Neonatal Pediatric Congenital Diaphragmatic Hernia Meconium Aspiration Syndrome Persistent Pulmonary Hypertension Respiratory Distress Syndrome Pneumonia Sepsis Congenital Heart Disease Sepsis Pneumonia/Respiratory Failure Trauma Smoke Inhalation Near Drowning ECMO Team Pediatric Surgery Cardiovascular Surgery Pediatric Intensivists Neonatal Intensivists Pediatric Cardiology Maternal-Fetal Medicine Pediatric Pulmonary ECMO Nurses Perfusion Team

  22. Possible Brain Insult At Birth? Call (24/7): (866) WMC-PEDS or (866) 468-6962 A.S.A.P. Cool within 6 hours of birth

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