Therapeutic Hypothermia for Birth Asphyxia Using a New Servo-Controlled Device—A Randomised Controlled Trial

Introduction Therapeutic hypothermia (TH) is the standard of care for moderate-to-severe birth asphyxia in high-resource settings, improving the long-term neurodevelopmental outcomes in infants with perinatal asphyxia. While widely adopted in neonatal units nationwide, TH is administered through servo-controlled methods like Tecotherm, CradleCool and manual methods using PCM mattress like Mira Cradle (by Pluss Advanced Technologies Pvt Ltd). Financial challenges in developing nations prompt the evaluation of Revive (Sensivision Health Technologies Pvt Ltd), a low-cost servo thermoregulation device against Mira Cradle in our neonatal unit for thermoregulation and immediate clinical outcomes. Objective The aim of this article was to study the thermoregulation achieved (effective cooling time) and immediate clinical outcomes through Revive, servo-controlled device and Mira Cradle, PCM manual device for TH. Study Design Randomised controlled trial. Participants Seventy neonates admitted to Bapuji Child Health Institute in Davanagere, Karnataka for birth asphyxia with moderate-to-severe hypoxic–ischaemic encephalopathy. Intervention TH was initiated via servo-controlled ( n = 24) or manual method ( n = 28) within 6 hours of birth for 72 hours, followed by passive rewarming. Outcomes Measures Thermoregulation parameters like effective cooling time, lowest and highest core temperature, deviations from required temperature, clinico-biological outcomes, dropout reasons and mortality. Results Servo-controlled method achieved a higher effective cooling time (91%, P <.05) compared to manual method (68%). It also exhibited enhanced safety, with no deviation of core temperature below 32°C, in contrast to manual method with 11 patients showing deviations. Neurological outcomes showed no significant differences, but the PCM group (manual method) experienced more complications. Importantly, no death occurred with the servo-controlled method, while three were observed in the manual method group. Conclusion The low-cost servo-controlled method proved effective for TH offering good efficacy and safety in resource-constrained settings. It emerges as advantageous for treating TH overall. Trial Registry Name Clinical Trial Registry—India.