BEMPU Health
TempWatchPeer-Reviewed PublicationRandomised Controlled Trial

Decreasing Hypothermia-Related Escalation of Care in Newborn Infants Using the BEMPU TempWatch: A Randomised Controlled Trial

Year

2021

Location

🇦🇺 Melbourne, Australia

Sample Size

75 newborns (RCT, stopped early)

Investigators

Donna Lei, Kenneth Tan, Atul Malhotra

Institutions

Monash University · Monash Children's Hospital · Hudson Institute of Medical Research, Melbourne

Published In

Children

Background & Methods

A randomized controlled trial at Monash Children's Hospital, Melbourne, to determine whether continuous temperature monitoring with the BEMPU TempWatch could reduce hypothermia-related escalation of care in newborn infants. 75 newborns were randomized to TempWatch (n=38) or standard care (n=37). The trial was stopped early when the primary endpoint (escalation of care) was lower than the anticipated rate in both groups. Pre-specified secondary analysis of breastfeeding outcomes was conducted.

Key Results

Outcome / MetricBEMPU Groupp-value
Breastfeeding at discharge (relative risk, TempWatch vs control)RR 1.83 (favours TempWatch)0.02
  • 1The trial was stopped early due to a lower-than-anticipated rate of hypothermia-related escalation of care in the study population.
  • 2A significant secondary finding: infants in the TempWatch group were 1.83 times more likely to be breastfeeding at discharge (p=0.02).
  • 3The breastfeeding benefit may reflect increased maternal engagement and skin-to-skin contact prompted by TempWatch alerts.
  • 4No safety concerns were identified with the device.

Why This Matters

This is the only RCT of TempWatch conducted in a high-income country (Australia), providing evidence of benefit in a well-resourced NICU setting. The unexpected breastfeeding benefit suggests that the device's primary value extends beyond temperature management to fostering maternal-infant bonding behaviors.

How to Cite

Lei D, Tan K, Malhotra A. Decreasing hypothermia-related escalation of care in newborn infants using the BEMPU TempWatch: a randomised controlled trial. Children. 2021;8(12):1068.