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Trial registered on ANZCTR


Registration number
ACTRN12624000503527p
Ethics application status
Submitted, not yet approved
Date submitted
22/03/2024
Date registered
24/04/2024
Date last updated
24/04/2024
Date data sharing statement initially provided
24/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Heating On Transport WitH prEtErm and Low birth weight neonates using Servocontrol patient temperature management system (HOTWHEELS): A pragmatic randomised controlled trial
Scientific title
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
Secondary ID [1] 311797 0
RGS0000006433
Universal Trial Number (UTN)
Trial acronym
Heating On Transport WitH prEtErm and Low birthweight neonates using Servocontrol (HOTWHEELS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 333305 0
Low Birth Weight Infants 333306 0
Thermoregulation 333307 0
Neonatal Transport/Retrieval 333308 0
Condition category
Condition code
Reproductive Health and Childbirth 329991 329991 0 0
Complications of newborn
Public Health 330225 330225 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328243 0
Treatment: Devices
Intervention code [2] 328244 0
Diagnosis / Prognosis
Intervention code [3] 328245 0
Prevention
Comparator / control treatment
The control group is the current standard treatment and care. NETS WA provides thermal control to preterm babies during transport using a few methods. The main way is an Airborne ® Voyager transport incubator (international biomedical, TX, USA). The temperature of the cot is set at 33-36 degrees Celsius. In addition to the transport incubator a TransWarmer ® thermal mattress (Cooper surgical, CT, USA) is used to provide an additional heat source. The third element is a sterile polythene suit to minimise environmental heat loss (Neohelp (Vygon, Ecouen, France). A hat is also placed on the baby’s head. The temperature of the baby is checked every 15 minutes using skin temperature probe and axilla temperatures. These interventions have developed over time and in response to changes to thermal control in the static neonatal intensive care environment. This is the current standard of care for preterm babies requiring transport after birth.

Given the multiple interventions of standard care we have devised a standard thermoregulation guideline with a detailed thermoregulation flowchart to ensure the retrieval specialist doctors and nurses adhere to according to the latest best evidence. This will be applied throughout the duration of NETs transport. We will also be using electronic medical records, which is routinely collected during retrieval to monitor adherence. If the temperature falls outside target ranges we will manual increase and decrease the cot temperature, apply the chemical mattress if the temperature is still below target range.
Control group
Active

Outcomes
Primary outcome [1] 337755 0
The primary outcome measure is the proportion of infants in the normal thermal range (36.5– 37.5 degrees Celsius) on admission to neonatal intensive care unit (NICU)
Timepoint [1] 337755 0
From baseline at arrival of transport team at referral hospital until handover to receiving team upon admission to NICU
Secondary outcome [1] 433155 0
The proportion of infants with mild hypothermia (36.0–36.4 degrees Celsius)
Timepoint [1] 433155 0
On admission to NICU
Secondary outcome [2] 433156 0
Proportion of infants with temperature <36.0 degrees Celsius on admission to NICU
Timepoint [2] 433156 0
On admission to NICU
Secondary outcome [3] 433157 0
Proportion of infants with temperature >37.5 degrees Celsius (hyperthermia)
Timepoint [3] 433157 0
On admission to NICU
Secondary outcome [4] 433158 0
Temperature at one hour of admission in NICU.
Timepoint [4] 433158 0
One hour after admission in NICU.
Secondary outcome [5] 433159 0
The change in temperature from first contact with the NETS team to arrival in NICU.
Timepoint [5] 433159 0
From baseline at arrival of transport team at referral hospital until handover to receiving team on admission to NICU
Secondary outcome [6] 433160 0
Serious adverse events (SAE) (hypothermia <35 degrees Celsius; hyperthermia >39 Celsius.
Timepoint [6] 433160 0
From baseline at arrival of transport team at referral hospital until handover to receiving team on admission to NICU
Secondary outcome [7] 433161 0
Adverse events related to the use of servo-controlled mattresses including incidence of skin of rectal lining trauma.
Timepoint [7] 433161 0
From baseline until discharge from neonatal unit
Secondary outcome [8] 433162 0
The proportion of intraventricular haemorrhage (all grades and grade III- IV) in first 7 days of life.
Timepoint [8] 433162 0
Day 7 ultrasound head scans at destination hospital
Secondary outcome [9] 433163 0
Mortality before discharge.
Timepoint [9] 433163 0
From baseline until discharge from destination hospital

Eligibility
Key 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.
Minimum age
0 Hours
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation of patients will be done via REDCap. Permuted blocks (sizes 4 and 6) will be used, with the randomisation list (order) will be generated by an independent statistician using https://www.sealedenvelope.com/, with the list then loaded into the study REDCap database to provide participants with a treatment allocation at the time of consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomly assigned to either servo-controlled system (intervention arm) or standard thermal care (control arm) in a 1:1 ratio. Permuted blocks (sizes 4 and 6) will be used
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Between 2016 and 2020 approximately there approximately 568 infants born less than or equal to 34 weeks’ gestation and/or less than or equal to 1500 g (average 113 infants per year). Based on unpublished observation data (2016 – 2020), assuming that 20% of the subjects in the standard care group whose temperature was outside the range (36.5 – 37.5 degrees Celsius) the study would require a sample size of 86 for each group (i.e. a total sample size of 172, assuming equal group sizes) to achieve a power of 80% for detecting a difference in proportions of -0.15 (i.e. reduction to 5% in the servo-controlled group) between the two groups at a two sided p-value of 0.05. To obtain the study target of 172 in 3 years, we would require a recruitment rate of 51% of the total target patient number per year. We believe this is obtainable.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
3/05/2027
Actual
Date of last data collection
Anticipated
14/06/2027
Actual
Sample size
Target
172
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316131 0
Charities/Societies/Foundations
Name [1] 316131 0
Perth Children's Hospital Foundation
Country [1] 316131 0
Australia
Funding source category [2] 316132 0
Hospital
Name [2] 316132 0
CAHS Perth Children's Hospital
Country [2] 316132 0
Australia
Primary sponsor type
Hospital
Name
CAHS Perth Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 318307 0
Charities/Societies/Foundations
Name [1] 318307 0
Perth Children's Hospital Foundation
Address [1] 318307 0
Country [1] 318307 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314959 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 314959 0
https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
Ethics committee country [1] 314959 0
Australia
Date submitted for ethics approval [1] 314959 0
22/01/2024
Approval date [1] 314959 0
Ethics approval number [1] 314959 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133254 0
A/Prof Jonathan Davis
Address 133254 0
Newborn Emergency Transport Service (NETS), Ward 3b, Level 3, 15 Hospital Ave, Nedlands WA 6009
Country 133254 0
Australia
Phone 133254 0
+61 0864565392
Fax 133254 0
Email 133254 0
jonathan.davis@health.wa.gov.au
Contact person for public queries
Name 133255 0
Jonathan Davis
Address 133255 0
Newborn Emergency Transport Service (NETS), Ward 3b, Level 3, 15 Hospital Ave, Nedlands WA 6009
Country 133255 0
Australia
Phone 133255 0
+61 0864565392
Fax 133255 0
Email 133255 0
jonathan.davis@health.wa.gov.au
Contact person for scientific queries
Name 133256 0
Jonathan Davis
Address 133256 0
Newborn Emergency Transport Service (NETS), Ward 3b, Level 3, 15 Hospital Ave, Nedlands WA 6009
Country 133256 0
Australia
Phone 133256 0
+61 0864565392
Fax 133256 0
Email 133256 0
jonathan.davis@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification and results published in research paper
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Anyone who wishes to access it through research journal publication
Available for what types of analyses?
Any purpose only to achieve the aims in the approved proposal and potentially for IPD meta-analyses
How or where can data be obtained?
Unrestricted access to public once approved and published in scientific journal


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21926Study protocol    387549-(Uploaded-18-04-2024-22-21-49)-Study-related document.docx
21927Informed consent form    387549-(Uploaded-18-04-2024-22-20-37)-Study-related document.docx
21928Informed consent form    387549-(Uploaded-11-04-2024-19-25-36)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.