ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000293965

Ethics application status

Approved

Date submitted

24/02/2020

Date registered

4/03/2020

Date last updated

14/06/2023

Date data sharing statement initially provided

4/03/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Randomised study regarding the site of temperature probe placement in very preterm infants at birth

Scientific title

Where should the temperature probe be secured during preterm infant resuscitation? A Randomised trial

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

TEMPP Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Premature Birth

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention being studied is the best position on the skin for the temperature probe to be placed at the time of birth for preterm infants 23-31+6 weeks gestation.

This study examines the placement of a skin temperature probe at the time of birth to determine the best position for monitoring and maintaining the infant's temperature before the baby is admitted to the Neonatal Intensive Care Unit (NICU). The skin temperature probe is a thin wire device that is placed on the skin of the baby and covered with a 2-3cm reflective sticker. The temperature probe attaches to the resuscitation bed and controls the heater output of the resuscitation bed based on the infant's temperature to achieve a desired temperature of 37.0'C. The temperature probe is applied to the infant's skin by a trained neonatal nurse, who is present at the time of the infant's birth, when the infant is placed on the resuscitation bed (within the first two minutes of the infant's life) and remains on the infant until admission to the Neonatal Intensive Care unit, which occurs approximately 20-30 minutes after birth.

The intervention group will have the temperature probe placed on the left upper back at the time of birth. The temperatures are compared with the admission temperature taken by a digital thermometer, placed in the armpit, on admission to the NICU to determine if one site is better than the other.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The control group has the skin temperature probe placed in the left armpit, which is the current practice at time of delivery.

Control group

Active

Outcomes

Primary outcome [1]

The proportion of premature infants (23+0-31+6 weeks' gestation) who have their admission temperature within the target range (36.8-37.3'C) at the time of admission to the NICU. This temperature is measured with a thermometer placed in the armpit of the baby within one minute of arriving to the NICU, and before being transferred from the resuscitation bed to an incubator.

Timepoint [1]

Approximately 20-30 minutes from the time of birth, and recorded within one minute of arrival to the NICU.

Secondary outcome [1]

Complications associated with low body temperature at birth, including:
-Death
-Major intra-ventricular haemorrhage (grade 3 or 4)
-Early or Late onset culture proven sepsis
-Necrotising Enterocolitis
-Cystic peri-ventricular leucomalacia
-Retinopathy of prematurity which requires surgery
-Neonatal chronic lung disease

This data will be collected from the infants' medical records.

Timepoint [1]

At the time of discharge of the infant.

Eligibility

Key inclusion criteria

Gestational Age <32 weeks
Born at Westmead Hospital

Minimum age

0 Hours

Maximum age

1 Hours

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Ex-utero transfer
Severe congenital malformations
Severe asphyxia requiring cardiac compressions and adrenaline
Birth prior to arrival of the NICU team
Congenital cutaneous lesions
No parental consent

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Consecutively numbered opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation, stratified for gestation (23-27 weeks or 28-31 weeks)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

This study requires 178 babies (89 per group) to be able to detect a difference between groups, and has been powered for this.

Demographic and clinical characteristics of the infants, as well as study outcomes, will be described by the randomised treatment and overall using standard statistical methods such as percentages and ranges, with comparisons made between the two groups.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

16/11/2018

Date of last participant enrolment

Anticipated

31/07/2022

Actual

31/07/2022

Date of last data collection

Anticipated

31/12/2022

Actual

31/12/2022

Sample size

Target

178

Accrual to date

Final

178

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Westmead Hospital

Address [1]

Research Office
Western Sydney Local Health District
Westmead Hospital
Hawkesbury and Darcy Rds.
Westmead NSW 2145

Country [1]

Australia

Primary sponsor type

Hospital

Name

Western Sydney Local Health District

Address

Research Office
Western Sydney Local Health District
Westmead Hospital
Hawkesbury and Darcy Rds.
Westmead NSW 2145

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District HREC

Ethics committee address [1]

Research Office, Level 2, REN Building
Westmead Hospital, 
Hawkesbury & Darcy Roads, 
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/07/2018

Ethics approval number [1]

AU RED HREC/18/WMEAD/192

Summary

Brief summary

This study is testing a new way to monitor body temperature of premature infants (23-31 weeks' gestation) to prevent them being too hot or too cold on admission to the NICU. Specifically, it is looking at whether the left back or left armpit is a better place to keep a skin temperature probe to monitor and maintain the infants' temperature from the time they are born until they are admitted to the NICU.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Pranav Jani

Address

Neonatal Intensive Care Unit
Westmead Hospital
Hawkesbury and Darcy Rds
Westmead NSW 2145

Country

Australia

Phone

+61 2 8890 7375

Fax

pranav.jani@health.nsw.gov.au

Contact person for public queries

Name

Pranav Jani

Address

Neonatal Intensive Care Unit
Westmead Hospital
Hawkesbury and Darcy Rds
Westmead NSW 2145

Country

Australia

Phone

+61 2 8890 7375

Fax

pranav.jani@health.nsw.gov.au

Contact person for scientific queries

Name

Pranav Jani

Address

Neonatal Intensive Care Unit
Westmead Hospital
Hawkesbury and Darcy Rds
Westmead NSW 2145

Country

Australia

Phone

+61 2 8890 7375

Fax

pranav.jani@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Single centre study

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Temperature probe placement in very preterm infants during delivery room stabilization: an open-label randomized trial	2024	https://doi.org/10.1038/s41390-024-03115-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically