Temperature control and short-term outcomes of phase-changing material versus servo-controlled whole-body cooling in neonates with hypoxic-ischemic encephalopathy:  a prospective comparative cohort study

Shrikant Giri; Pallavi Giri; Monika Jaiswal; Pratibha Agarwal; Abhijeet C. Bhoyar

doi:10.18203/2349-3291.ijcp20263820

Authors

Shrikant Giri Shri Shishu Bhawan, Bilaspur, Chhattisgarh, India
Pallavi Giri Shri Shishu Bhawan, Bilaspur, Chhattisgarh, India
Monika Jaiswal Shri Shishu Bhawan, Bilaspur, Chhattisgarh, India
Pratibha Agarwal Shri Shishu Bhawan, Bilaspur, Chhattisgarh, India
Abhijeet C. Bhoyar Shri Shishu Bhawan, Bilaspur, Chhattisgarh, India

DOI:

https://doi.org/10.18203/2349-3291.ijcp20263820

Keywords:

hypoxic-ischaemic encephalopathy, Therapeutic hypothermia, Phase-changing material, Servo-controlled cooling, Neonate

Abstract

Background: Therapeutic hypothermia improves outcomes in neonates with moderate-to-severe hypoxic-ischaemic encephalopathy (HIE), but access to servo-controlled systems may be limited. Phase-changing material (PCM) devices are a lower-complexity alternative requiring continuous core-temperature monitoring.

Methods: This prospective, single-centre, observational comparative cohort study included 60 neonates with moderate-to-severe HIE treated for 72 hours with either servo-controlled whole-body cooling (n=30) or PCM cooling (n=30). Allocation was non-randomised and determined by device availability at admission. The primary outcomes were time to target temperature (33.5-34.5°C) and proportion of cooling time within the target range. Secondary outcomes included rewarming duration, respiratory and haemodynamic support, complications, treatment completion, seizures, neuroimaging and neurological status at discharge.

Results: Servo-controlled cooling reached target temperature faster than PCM cooling (1.81±0.37 vs 2.53±0.77 hours; mean difference -0.72 hours, 95% CI -1.03 to -0.41; p<0.001) and maintained the target range for a greater proportion of cooling time (90.94±4.38% vs 79.52±6.86%; mean difference 11.42 percentage points, 95% CI 8.45 to 14.39; p<0.001). Rewarming duration did not differ significantly (7.10±0.99 vs 7.48±1.16 hours; p=0.175). No statistically significant between-group differences were detected for ventilation, inotropic support, thrombocytopenia, coagulopathy, electrolyte abnormalities, skin complications, completion of 72-hour cooling, seizures, neuroimaging or discharge neurological outcome. In exploratory multivariable analysis, HIE severity, timing of cooling and occurrence of a major adverse event were associated with unfavourable discharge outcome; cooling modality was not (adjusted OR 0.71, 95% CI 0.21-2.38; p=0.581).

Conclusions: In this small, non-randomised cohort, servo-controlled cooling provided faster and more precise temperature control than PCM cooling. PCM cooling was feasible when continuous core-temperature monitoring and intensive neonatal care were available. The study did not establish equivalence of PCM and servo-controlled cooling for clinical or neurological outcomes.

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