therapeutic hypothermia are we ready?babathakranwala.in/iapneochap/uploads/presentation/27.pdf ·...
TRANSCRIPT
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Therapeutic hypothermia
– Are we ready?
M Jeeva Sankar DM (Neo)
AIIMS, New Delhi
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Are we ready?
Depends!
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Are we ready?
Questions
1.Why?
– Science, evidence
2.Why not?
– Practical difficulties, cost, …
3.Should we?
– Balance between why & why not?
4.How?
– Solutions
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Why?
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Causes of child deaths
Liu, Lancet 2015
2nd common cause of neonatal deaths!
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Asphyxia – Management
Intervention No. of studies
Type of Study
No. of infants
Long- term
outcome
Conclusion
Magnesium sulfate
1
1
Safety
RCT
15
33
N.A
N.A
Higher dose: Hypotension; low dose: Resp. depression can occur
Better short term outcomes (CT scan, EEG and oral feeds by 14 days)
Allopurinol 1
1
RCT
Systemic Review
22 ? Available No difference in the mortality & long-term outcome
Insufficient evidence
Calcium channel blockers
1 Case-series
4 N.A No RCTs so far
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Intervention No. of studies
Type of Study
No. of infants
Long- term
outcome
Conclusion
Steroids 1 Case-series
? N.A No effects on cerebral perfusion pressure
Mannitol 1 RCT 25 N.A No difference in the mortality
Opiate antagonists
1
1
RCT
Cochrane
193 N.A No difference in HR/RR; Increased muscle tone of UL & LL
No evidence for effect on mortality or long-term outcome
Phenobarbital (prophylactic)
3
1
RCT
Cochrane
110
YES No difference in mortality or long-term outcome
Same; but all studies have methodological weakness
Asphyxia – Management
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Asphyxia - Management
Only supportive care!
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Therapeutic hypothermia
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How it acts?
11
Energy depletion
Glutamate release
Glutamate reuptake
Free radical generation
Blocks downstream mech. of apoptosis/necrosis
Inhibits inflammation
1
2
3
4
5
6
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Evidence
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Is it effective?
Cochrane 2013
Reduces mortality/disability by 25%
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Is it effective?
Cochrane 2013
Reduces mortality alone by 25%
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Is it effective?
Cochrane 2013
Reduces disability by 33%
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Why?
• Any other modality? - No
• Science - Yes
• Evidence - Yes
Standard of care!
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Why not to use?
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India: Peculiar situation
• Population differences
• Practical issues
• Cost
• Evidence
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Population differences
Brain injury – begins in utero
•Maternal malnutrition/anemia
•IUGR
•Poor antenatal care
•Home deliveries – poor perinatal care
? Less beneficial
Wilkinson 2010
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Population differences…
Sepsis
•Hypothermia
– affects neutrophil function
– Can worsen sepsis and pneumonia
•Difficult to differentiate sepsis and asphyxia
Uganda trial – Increased mortality!
Wilkinson 2010
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Population differences…
Late referral and others
•Reach after 6 hours
•Most – multiorgan dysfunction
– Kidneys
– Heart
•Many – MAS and PPHN
Less effective; may be harmful
Wilkinson 2010
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Practical issues
Adverse events
Thomas 2011
Needs 24-hr monitoring!
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Cost
Cost – 5 to 30 lakhs!
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Evidence in LMIC
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Evidence in LMIC
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Efficacy: Mortality
No difference in mortality!
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Safety: Sepsis
No difference in sepsis!
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No future?
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Should we?
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Population differences
Brain injury – begins in utero
•Maternal malnutrition/anemia
•Poor antenatal care
•Home deliveries
•IUGR
Improve ANTENATAL care;
facility births!
Research idea 1:
Efficacy of hypothermia in IUGR!
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Population differences
Sepsis
•Hypothermia
– affects neutrophil function
– Can worsen sepsis and pneumonia
•Difficult to differentiate sepsis and asphyxia
Early diagnosis of sepsis!
Research idea 2:
Safety in asphyxia and sepsis!
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Population differences
Late referral and others
•Reach after 6 hours
•Most – multiorgan dysfunction
– Kidneys
– Heart
•Many – MAS and PPHN
Early referral!
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Practical issues
Level of intensive care
Thomas 2011
Ensure monitoring, lab facilities, blood bank!
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Cost
Low-cost devices!
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Options
Low tech devices
• Water bottles
• Fans
• Gels
• Ice packs
• Phase changing mattresses
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Cooling using ice packs
Thomas 2011
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Options
Cost: 125 000 INR!
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Evidence in LMIC
Small sample size!
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2015 ILCOR guidelines
ILCOR recommends!
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How?
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4P for optimum TH implementation Place Personnel Paraphernalia Protocols
• Level-3 NICU
(desirable)
• Well
established
Level-2 NICU
• Trained
Pediatrician
• Nursing staff
• Radiant Warmer
• Cooling device
• Rectal probes for
temperature
monitoring
• Multiparametric
monitors
• ABG machine
• Mechanical ventilator
• Glucometer
• aEEG (desirable)
• MRI (desirable)
• Timely
identification of
HIE
• Ensuring TH within
6 h of birth
• Evidence-based
standard protocol
for providing and
monitoring TH
• 24 x 7 monitoring
• Standardized
neurodevelopment
follow-up
• Continuing staff
education
Bhat VB, IJP 2014
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Conclusion
• Level-3 units
– Start cooling with adequate monitoring
• Level-2 units
– Establish facilities required (monitoring; lab)
– Low-cost devices (if monitoring feasible)
– Early referral (if no facilities)
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Conclusion
Therapeutic hypothermia
– Are we ready?
Therapeutic hypothermia
– Make ourselves ready!