None listed
Conditions
Brief 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.
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 targ
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.
Sponsors
CAHS Perth Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
i. Corrected Gestational age less than or equal to 34 weeks and/or ii. Current weight less than or equal to 1500 g iii. Informed parental consent. iv. Sufficient understanding of English language.
Exclusion criteria
(i) major congenital gastrointestinal abnormality (e.g., gut wall abnormality, imperforate anus or tracheoesophageal fistula or atresia) (ii) Necrotising enterocolitis (iii) parental refusal to participate
Outcome results
None listed