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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]

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

Low Birth Weight Infants

Thermoregulation

Neonatal Transport/Retrieval

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Public Health

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]

Treatment: Devices

Intervention code [2]

Diagnosis / Prognosis

Intervention code [3]

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]

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]

From baseline at arrival of transport team at referral hospital until handover to receiving team upon admission to NICU

Secondary outcome [1]

The proportion of infants with mild hypothermia (36.0–36.4 degrees Celsius)

Timepoint [1]

On admission to NICU

Secondary outcome [2]

Proportion of infants with temperature <36.0 degrees Celsius on admission to NICU

Timepoint [2]

On admission to NICU

Secondary outcome [3]

Proportion of infants with temperature >37.5 degrees Celsius (hyperthermia)

Timepoint [3]

On admission to NICU

Secondary outcome [4]

Temperature at one hour of admission in NICU.

Timepoint [4]

One hour after admission in NICU.

Secondary outcome [5]

The change in temperature from first contact with the NETS team to arrival in NICU.

Timepoint [5]

From baseline at arrival of transport team at referral hospital until handover to receiving team on admission to NICU

Secondary outcome [6]

Serious adverse events (SAE) (hypothermia <35 degrees Celsius; hyperthermia >39 Celsius.

Timepoint [6]

From baseline at arrival of transport team at referral hospital until handover to receiving team on admission to NICU

Secondary outcome [7]

Adverse events related to the use of servo-controlled mattresses including incidence of skin of rectal lining trauma.

Timepoint [7]

From baseline until discharge from neonatal unit

Secondary outcome [8]

The proportion of intraventricular haemorrhage (all grades and grade III- IV) in first 7 days of life.

Timepoint [8]

Day 7 ultrasound head scans at destination hospital

Secondary outcome [9]

Mortality before discharge.

Timepoint [9]

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?

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)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Perth Children's Hospital Foundation

Address [1]

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

CAHS Perth Children's Hospital

Address [2]

Country [2]

Australia

Primary sponsor type

Hospital

Name

CAHS Perth Children's Hospital

Address

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Perth Children's Hospital Foundation

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Child and Adolescent Health Service Human Research Ethics Committee

Ethics committee address [1]

https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/01/2024

Approval date [1]

Ethics approval number [1]

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

A/Prof Jonathan Davis

Address

Newborn Emergency Transport Service (NETS), Ward 3b, Level 3, 15 Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 0864565392

Fax

[email protected]

Contact person for public queries

Name

Jonathan Davis

Address

Newborn Emergency Transport Service (NETS), Ward 3b, Level 3, 15 Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 0864565392

Fax

[email protected]

Contact person for scientific queries

Name

Jonathan Davis

Address

Newborn Emergency Transport Service (NETS), Ward 3b, Level 3, 15 Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 0864565392

Fax

[email protected]

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.	Type	Attachment
21926	Study protocol	387549-(Uploaded-18-04-2024-22-21-49)-Study-related document.docx
21927	Informed consent form	387549-(Uploaded-18-04-2024-22-20-37)-Study-related document.docx
21928	Informed 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.

Trial Review

Documents added manually

Documents added automatically