1. Clinical Assessment vs
Clinical Assessment vs. Cerebral Function Monitoring – Implications for therapeutic hypothermia in a managed clinical network
Malini Ketty
Nitin Goel
Sujoy Banerjee
Neonatal Unit, Singleton Hospital

2. Background Case selection for Therapeutic Hypothermia
Trial Criteria : TOBY study / NICHD (Shankaran) study
Establishment of Hypoxia + Encephalopathy (clinical & aEEG)
Extrapolation of trial criteria in clinical practice
Neurological assessment – subjective
CFM (aEEG) is gold standard for initial bedside encephalopathy assessment
The 5 assessment areas include level of consciousness, neuromuscular control, reflexes, autonomic function, and evidence of seizures

3. Background Non-availability of CFM in all referral centres
Therapeutic drift towards active hypothermia
Implementation of hypothermia in borderline cases:
Neonatal Transfer, Critical care
Separation from parents
Resource implications – cots, logistics, manpower
Long term effects of cooling OUTSIDE the trial criteria not yet known.

4. Aims
To examine the concordance of clinical encephalopathy assessments with CFM grades
To discuss the implications for the neonatal network.

5. Methods Retrospective analysis
Cases identified from unit cooling register
Data collected from TOBY forms and case notes
Grade of clinically assessed encephalopathy compared with CFM grades

6. Results *20/32 (62%) were outborn 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
*20/32 (62%) were outborn

7. Encephalopathy as per clinical assessment
Clinical encephalopathy
n = 32
Mild 6
Cooling stopped < 72 Hrs (normal CFM, neurology) 4
Survived
Cooled for 72 Hrs 2
Moderate 17
Cooling stopped
(worsening) 1 16
Severe 9 5
Died 3

8. Cerebral function monitoring (aEEG)
CFM
n = 32
Normal 15
Cooling stopped
< 72 Hrs 5
Survived
Cooled for 72 Hrs
10* 10
Moderately abnormal 8 7
Died 1
Severely abnormal 9 3 2
(worsening) 4
*Nine (90%) of the 10 cooled with normal CFM were outborn.

9. Correlation of clinical assessment with CFM

10. Correlation of clinical assessment with CFM

11. Correlation of clinical assessment with CFM
In 13/32 (40%) infants, clinical assessment matched with CFM
In the discordant group (19/32):
16(84%) had lesser and
3(16%) had more severe grade with CFM.
Concordance was worse in the moderate encephalopathic group (29%) when compared to the mild (83 %) and severe (78%).

12. Conclusions
Therapeutic hypothermia is being offered to milder grades of HIE, often to infants born outside the treatment centre.
Clinical grading of encephalopathy is unreliable when compared to the gold standard of CFM in selecting cases suitable for TH.
Concordance with CFM was worst in the moderate encephalopathy

13. Recommendations Strict adherence to Encephalopathy assessment criteria
Consideration to equip referral units with CFM
More reliable assessment of the grade of brain injury
Support could be provided by cooling centre 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.

14. THANK YOU for your attention

15. Outcome of moderate & severe encephalopathy
Difficult to make any judgements about the outcomes in 20 babies.

16. Outcome in survivors with normal CFM and cooled for 72 hours