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

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

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.

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

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

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

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

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.

Correlation of clinical assessment with CFM

Correlation of clinical assessment with CFM

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%).

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

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.

THANK YOU for your attention

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

Outcome in survivors with normal CFM and cooled for 72 hours