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Caroline O. Chua, MD Chief, Neonatal Fellow Regional NICU Maria Fareri Children’s Hospital at Westchester Medical Center Lance A. Parton, MD Associate.

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Presentation on theme: "Caroline O. Chua, MD Chief, Neonatal Fellow Regional NICU Maria Fareri Children’s Hospital at Westchester Medical Center Lance A. Parton, MD Associate."— Presentation transcript:

1 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) 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 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 Etiologies: abruptio (25%), uterine rupture, prepartum hemorrhage, dystocia, prolapsed cord, placental insufficiency, twins, extramural deliveries Mortality is 15-20% Mortality is 15-20% >25% of survivors have permanent disabilities

3 HYPOXIA - ISCHEMIA Anaerobic Glycolysis ATP Glutamate NMDA Receptor Intracellular Ca+ Activates Lipases Free Fatty Acids Free Radicals O2O2 Adenosine Hypoxanthine Xanthine Free Radicals O2O2 Lactate Activates NOS NO Free Radicals NEURONAL CELL DEATH Superoxide radicals Xanthine oxidase inhibitors NMDA receptor blocker Ca+ channel blocker Hypothermia Free radical scavengers Cyclooxygenase inhibitors Activates proteases Activates nuclease Disruption of cytoskeleton Damage to DNA

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

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

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

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

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

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

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

11 Predictive Calculations of Efficacy for Hypothermia to treat Neonatal HIE Perlman and Shah, babies are born daily in the U.S. with moderate to severe HIE 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 10-12, of the above, die or develop moderate to severe disability Hypothermia to all babies would prevent 3 from death or moderate to severe disability without any significant adverse effects Hypothermia to all 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 with clinical evidence of 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 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 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 Apgar score ≤ 5 at 10 min Continued need for resuscitation, including endotracheal or mask ventilation, at 10 min after birth 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 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) 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 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 Hypotonia Abnormal reflexes, including oculomotor or pupillary abnormalities Abnormal reflexes, including oculomotor or pupillary abnormalities Absent or weak suck Absent or weak suck Clinical seizures 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 Imperforate anus Evidence of head trauma or skull fracture causing major intracranial hemorrhage Evidence of head trauma or skull fracture causing major intracranial hemorrhage Birth weight < 1,800g Birth weight < 1,800g

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

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

19 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 Cool Cap ® in PlaceCool Cap® Monitor

20 E C M O ExtraCorporealMembraneOxygenation Maria Fareri Children’s Hospital Call (24/7): (866) WMC-PEDS or (866) Newborn Infant Child Young Adult

21 Extra Corporeal Membrane Oxygenation Heart-Lung Bypass Cardiovascular Surgery Pediatric Intensivists Neonatal Intensivists Pediatric Surgery Pediatric Cardiology Perfusion Team ECMO Nurses Maternal-Fetal Medicine Pediatric Pulmonary 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 Consider for the Following Conditions: NeonatalPediatric ECMOTeam

22 Call (24/7): (866) WMC-PEDS or (866) A.S.A.P. Cool within 6 hours of birth


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