1. Therapeutic Hypothermia in Neonatal Hypoxic-Ischaemic Encephalopathy An audit of clinical management and follow up
Malini Ketty, Nitin Goel, Sujoy Banerjee
Department of Neonatal Medicine, Singleton Hospital - Swansea

2. Therapeutic cooling in HIE
Standard of care in moderate to severe HIE
Reduction in death and major 2yrs (RR 0.75)
NNT =7
Whole body hypothermia C for 72 hrs
Target therapeutic temperature - within 6 hrs
Trial characteristics
Developed countries
Tertiary centres
Strict entry criteria
UK TOBY trial / Coolcap - aEEG for case selection
(a normal aEEG within 6 hours predicts with high probability a normal outcome)

3. Post-Trial era - Management challenges
Case selection - ? Therapeutic Drift
Referrals often originate in smaller centres
CFM recording facility unavailable before arrival in tertiary centre
Vague clinical criteria for encephalopathy - criteria ‘B’
Less experience and confidence in assessing clinical encephalopathy
Fear of litigation
Implementation of hypothermia
Active cooling equipment not available in most referring hospitals
Challenges in maintaining passive cooling following initiation and during transport
Late assessment of clinical situation in cooling centre - late arrival > 6 hours

4. Post-Trial era - Management challenges
C. Parents
Initial separation and anxiety
Managing expectation that cooling will be continued
Lack of intimate skin to skin contact during cooling
D. NHS resources
Cost of intensive care + Capacity management
Cost of transfer
Balancing cost / risk of treatment with risk of disability care / litigation
Follow up requirements

5. Audit Standards Case selection – Correlation with CFM grade
Target temperature (33-340C) - within 6 hours
Follow-up :
MRI brain within 2 weeks
Standardised neurodevelopment assessment at 2yrs
Offered to all (100%)
Undertaken within 3 months of 2nd birthday (85%)
Secondary aim: To review ND outcome in survivors at 2 years

6. Methods Retrospective analysis 2009-2011
Cases identified from unit cooling register
Data from TOBY forms, case notes, Bayley’s assessment reports, HSQs, Clinic letters etc

7. Results Survived 20 Mean weight = 3.55 ± 0.82 Kg
Babies with suspected HIE admitted to the unit 34
Cooling initiated
32*
Cooled for
72 Hrs 23
Died 3
Survived 20
Cooling stopped < 72 Hrs (normal CFM, neurology) 4
Cooling stopped < 72 Hrs
(clinical worsening) 5 1
Cooling not possible (DIC/PPHN) 2
Results
Mean weight = 3.55 ± 0.82 Kg
Mean gestation = 39.3 ± 1.6 Wks
*20/32 (62%) were outborn

8. Nearly a half had normal CFM
Cerebral function monitoring (aEEG)
Nearly a half had normal CFM
*Nine (90%) of the 10 cooled with Grade 1 CFM were outborn

9. Achievement of target temperature (n = 23)

10. Recommended imaging - MRI (n= 20)

11. Long term outcomes - assessment (n=20)

12. Overview of outcome in survivors

13. Comparative outcome in HIE survivors
Category
Standard care
With therapeutic hypothermia*
Singleton study cohort
(clinical encephalopathy)
Survival without disability in moderate to severe encephalopathy
28%
44%
57%
CP in survivors
41% 8%
Thornberg et al 1995
 NICE guidance

14. Conclusions
TH is being offered to milder grades of HIE, often to infants born outside the treatment centre
In 1/4th babies (mostly out born), target temperature for TH was not achieved within 6 hours
Most children had MRI scans within the recommended time frame
Almost all children underwent standardised assessment for long term outcome at the recommended time
Excellent long term outcome may be explained by therapeutic drift despite poor achievement of target temperature by 6 hours

15. Recommendation
Every unit must strive to achieve therapeutic hypothermia within 6 hours
The network / Transport Service must audit this important target outcome
Clinical assessment for encephalopathy should be more standardised and thorough (e.g. Use of Thomson criteria)
Consideration to equip referral units with CFM machines
Will provide reliable assessment of the grade of brain injury
Prevent unnecessary escalation, transport and separation from family
Diagnostic support could be provided by regional unit by reviewing images
The cost of the equipment and personnel training will be offset by the reduced cost of transfer, critical care cot occupancy and unnecessary emotional burden on the family.