RecruitingACTRN12624000503527

Heating On Transport WitH prEtErm and Low birth weight neonates using Servocontrol patient temperature management system (HOTWHEELS): A pragmatic randomised controlled trial

A pragmatic randomised controlled trial comparing the efficacy of servocontrol patient temperature management system with standard thermoregulation guidelines to maintain normal thermal range (36.5-37.5 degrees Celsius) during the transport of preterm and low birth weight babies soon after birth

Sponsor

CAHS Perth Children's Hospital

Enrollment

172 participants

Start Date

Jul 2, 2024

Study Type

Interventional

Conditions

Neonatal Transport/Retrieval Low Birth Weight Infants Thermoregulation Prematurity

Summary

Maintaining a normal temperature after birth is a major challenge for newborn survival and morbidity. Preterm infants less than or equal to 34 weeks’ gestation and less than or equal to 1500g weight are especially vulnerable to cold stress/hypothermia. Recommended interventions to prevent thermal loss at birth in preterm infants include moderation of environmental temperature, infant warmers, polythene bags/wraps, preheated mattresses, and heated and humidified gases. This randomised controlled trial compares two modalities (servocontrolled patient temperature management system vs. current standard) of thermoregulation during the transport of preterm and low birth weight babies soon after birth. We hypothesise that the servocontrol patient temperature management system will be more effective at maintaining babies temperature within normal range of 36.5-37.5 degrees Celsius. We aim to compare these two modalities to see which one is more effective at maintaining babies temperature during transport as a primary outcome and see whether it affects morbidity and mortality of preterm/low birthweight babies as a secondary outcome.

Eligibility

Sex: Both males and femalesMin Age: 0 Hourss

Plain Language Summary

Simplified for easier understanding

Premature babies — particularly those born before 34 weeks or weighing less than 1,500 grams — have difficulty keeping themselves warm. Getting too cold after birth can cause serious health problems. While hospitals use a range of methods to keep premature babies warm immediately after delivery, maintaining the right temperature during transport within the hospital remains a challenge. This randomised controlled trial compares the standard approach to temperature management during newborn transport with a new "servocontrolled" patient temperature management system, which automatically adjusts heat to keep the baby within the ideal temperature range of 36.5 to 37.5 degrees Celsius. The study will assess which method more reliably keeps babies in the target range, and whether this affects their health outcomes. This study involves premature or low birth weight babies. Infants born at 34 weeks gestation or less, or weighing 1,500 grams or less, may be eligible with parental consent. Babies with certain major congenital conditions are not eligible.

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Interventions

The intervention will involve the servocontrol patient temperature management system, which is an automated device that uses error sensing negative feedback to correct the action of a mechanism. The device requires the insertion of a rectal and skin temperature probe by the retrieval specialist doctor and nurses for continuous temperature monitoring throughout the duration of the Newborn Emergency Transport Service (NETs) transport. The temperature will be set at 37.0 degrees Celsius in the targeted temperature management mode in the servocontrol patient temperature management system. The infant will be wrapped in a proprietary plastic wrap to allow the servocontrol thermal regulation. It is a single use, one-piece, body-shaped, flexible garment that is easy to wrap and secure for the patient. A pressure relief algorithm periodically lets the water drain from the wrap, for slight repositioning of the patient, and specially designed channels within the garment distribute pressure. The machine will adjust the temperature of the wrap according to continuous feedback of the baby's temperature. Adherence will be monitored using electronic medical records, which is filled in during the retrieval of the patient. We will also be able to download data from the servocontrol device, which is able to collect live real time temperature data of the patient and the temperature adjustments on the device.