TY - JOUR
T1 - Phase Changing Material for Therapeutic Hypothermia in Neonates with Hypoxic Ischemic Encephalopathy — A Multi-centric Study
AU - Thomas, Niranjan
AU - Abiramalatha, Thangaraj
AU - Bhat, Vishnu
AU - Varanattu, Manoj
AU - Rao, Suman
AU - Wazir, Sanjay
AU - Lewis, Leslie
AU - Balakrishnan, Umamaheswari
AU - Murki, Srinivas
AU - Mittal, Jaikrishnan
AU - Dongara, Ashish
AU - Prashantha, Y. N.
AU - Nimbalkar, Somashekhar
N1 - Funding Information:
Contributors: NT: concept, design, data collection, data analysis, manuscript writing and review; AT, VB, MV, SR, SW, LL, UB, SM, JM, AD, PYN and SN: design, data collection, data analysis, manuscript writing and manuscript review; All authors approved the final version. Funding: The Miracradle-Neonate Cooler was supplied by Pluss Advaced technologies free-of-cost to all the participating centers. The workshop where the participants were trained (including travel and accommodation) in using the Miracradle was funded by Christian Medical College Vellore, Adit foundation and Indian Overseas Bank (funds from the latter two raised by Pluss Advaned technologies, the manufacturer of Miracradle). Competing interests: NT was involved in the concept and design of the Miracradle. None stated for other authors.
Publisher Copyright:
© 2017, Indian Academy of Pediatrics.
PY - 2018/3/1
Y1 - 2018/3/1
N2 - Objective: To assess the feasibility and safety of cooling asphyxiated neonates using phase changing material based device across different neonatal intensive care units in India. Design: Multi-centric uncontrolled clinical trial. Setting: 11 level 3 neonatal units in India from November 2014 to December 2015. Participants: 103 newborn infants with perinatal asphyxia, satisfying pre-defined criteria for therapeutic hypothermia. Intervention: Therapeutic hypothermia was provided using phase changing material based device to a target temperature of 33.5±0.5ºC, with a standard protocol. Core body temperature was monitored continuously using a rectal probe during the cooling and rewarming phase and for 12 hours after the rewarming was complete. Outcome measures: Feasibility measure - Time taken to reach target temperature, fluctuation of the core body temperature during the cooling phase and proportion of temperature recordings outside the target range. Safety measure - adverse events during cooling Results: The median (IQR) of time taken to reach target temperature was 90 (45, 120) minutes. The mean (SD) deviation of temperature during cooling phase was 33.5 (0.39) ºC. Temperature readings were outside the target range in 10.8% (5.1% of the readings were <33°C and 5.7% were >34°C). Mean (SD) of rate of rewarming was 0.28 (0.13)°C per hour. The common adverse events were shock/hypotension (18%), coagulopathy (21.4%), sepsis/probable sepsis (20.4%) and thrombocytopenia (10.7%). Cooling was discontinued before 72 hours in 18 (17.5%) babies due to reasons such as hemodynamic instability/refractory shock, persistent pulmonary hypertension or bleeding. 7 (6.8%) babies died during hospitalization. Conclusion: Using phase changing material based cooling device and a standard protocol, it was feasible and safe to provide therapeutic hypothermia to asphyxiated neonates across different neonatal units in India. Maintenance of target temperature was comparable to standard servo-controlled equipment.
AB - Objective: To assess the feasibility and safety of cooling asphyxiated neonates using phase changing material based device across different neonatal intensive care units in India. Design: Multi-centric uncontrolled clinical trial. Setting: 11 level 3 neonatal units in India from November 2014 to December 2015. Participants: 103 newborn infants with perinatal asphyxia, satisfying pre-defined criteria for therapeutic hypothermia. Intervention: Therapeutic hypothermia was provided using phase changing material based device to a target temperature of 33.5±0.5ºC, with a standard protocol. Core body temperature was monitored continuously using a rectal probe during the cooling and rewarming phase and for 12 hours after the rewarming was complete. Outcome measures: Feasibility measure - Time taken to reach target temperature, fluctuation of the core body temperature during the cooling phase and proportion of temperature recordings outside the target range. Safety measure - adverse events during cooling Results: The median (IQR) of time taken to reach target temperature was 90 (45, 120) minutes. The mean (SD) deviation of temperature during cooling phase was 33.5 (0.39) ºC. Temperature readings were outside the target range in 10.8% (5.1% of the readings were <33°C and 5.7% were >34°C). Mean (SD) of rate of rewarming was 0.28 (0.13)°C per hour. The common adverse events were shock/hypotension (18%), coagulopathy (21.4%), sepsis/probable sepsis (20.4%) and thrombocytopenia (10.7%). Cooling was discontinued before 72 hours in 18 (17.5%) babies due to reasons such as hemodynamic instability/refractory shock, persistent pulmonary hypertension or bleeding. 7 (6.8%) babies died during hospitalization. Conclusion: Using phase changing material based cooling device and a standard protocol, it was feasible and safe to provide therapeutic hypothermia to asphyxiated neonates across different neonatal units in India. Maintenance of target temperature was comparable to standard servo-controlled equipment.
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U2 - 10.1007/s13312-018-1317-1
DO - 10.1007/s13312-018-1317-1
M3 - Article
C2 - 29242417
AN - SCOPUS:85046047239
SN - 0019-6061
VL - 55
SP - 201
EP - 205
JO - Indian Pediatrics
JF - Indian Pediatrics
IS - 3
ER -