Cooling during transportation of newborns with hypoxic ischemic encephalopathy using phase change material mattresses in low-resource settings: a randomized controlled trial in Hanoi, Vietnam

Abstract

Objective: To determine the effectiveness of phase-change-material mattress (PCM) during transportation of newborns with hypoxic ischemic encephalopathy (HIE). Study design: Randomized controlled trial of newborns with HIE from June 2016 to December 2019. Patients were randomized to transport with PCM or without PCM (control) when transferred to a cooling center in northern Vietnam. Primary outcome measure was mortality rate, secondary outcomes including temperature control and adverse effects. Result: Fifty-Two patients in PCM-group and 61 in control group. Median rectal temperature upon arrival was 34.5 °C (IQR 33.5–34.8) in PCM-group and 35.1 °C (IQR 34.5–35.9) in control group (p = 0.023). Median time from birth to reach target temperature was 5.0 ± 1.4 h and 5.5 ± 1.2 h in the respective groups (p = 0.065). 81% of those transported with PCM versus 62% of infants transported without (p = 0.049) had reached target temperature within the 6-h timeframe. There was no record of overcooling (< 32 °C) in any of the groups. The was no difference in mortality rate between the two groups (33% and 34% respectively (p > 0.05)). Conclusion: Phase-change-material can be used as a safe and effective cooling method during transportation of newborns with HIE in low-resource settings. Trial registration: The study was retro-prospectively registered in Clinical Trials (04/05/2022, NCT05361473).