Heating On Transport WitH prEtErm and Low birth weight infants using servocontrol thermoregulation (HOTWHEELS): study protocol for a randomised controlled trial
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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 gestational age of ≤34 weeks and/or weight of ≤1500 g requiring transport are randomised to servocontrolled or standard thermal care. The primary outcome is the proportion of infants with a temperature between 36.5–37.5 °C on arrival at the receiving neonatal unit. Secondary outcomes include moderate (<36.0°C) and severe (<35.0°C) hypothermia ≥15 minutes and temperature change during transport, IVH≤7 days, and mortality before discharge. 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.
Category of study
Study protocol; special article
Impact Statement
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Thermoregulation is an independent predictor of morbidity and mortality in neonates.
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Preterm and low birth weight infants are highly vulnerable to temperature changes due to immature physiological mechanisms.
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Achieving and maintaining normothermia is challenging within hospital settings, and even more so in neonatal transport environment.
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Bundled thermoregulation care still fails to achieve normothermia in over >20% transported neonates