Heating On Transport WitH prEtErm and Low birth weight infants using servocontrol thermoregulation (HOTWHEELS): study protocol for a randomised controlled trial.

Background Temperature instability during neonatal transport contributes to adverse outcomes in preterm and low birth weight infants. Hypothermia in this population is associated with increased risk of intraventricular haemorrhage (IVH), sepsis, and death. Current transport temperature management is reactive and manually controlled. The Heating On Transport WitH prEtErm and Low birth weight neonates using Servocontrol patient temperature management system (HOTWHEELS) trial aims to determine whether automated, servo-controlled thermoregulation provides superior thermal stability compared to standard care and reduces hypothermia-associated adverse outcomes. Methods This prospective, randomised, superiority trial is conducted by the Newborn Emergency Transport Service of Western Australia. Infants with a gestational age of less than or equal to 34 weeks and/or weight of 1500 g requiring transport are randomised to serve-controlled or standard thermal care. The primary outcome is the proportion of infants with a temperature between 36.5 and 37.5 degrees Celsius on arrival at the receiving neonatal unit. Secondary outcomes include the incidence of IVH in the first 7 days, mortality before discharge, the incidence of moderate (<36.0) and severe (<35.0) hypothermia for greater than 15 minutes and the temperature change during transport. Trial registration: ANZCTR12624000503527. Impact HOTWHEELS is the first randomised trial in neonatal transport to evaluate servo-controlled temperature control. We believe the findings will inform standards of temperature control during transport for preterm and low birth weight infants.