Trial Review

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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] 300583 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
TEMPP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature Birth 316397 0
Condition category
Condition code
Reproductive Health and Childbirth 314664 314664 0 0
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] 316953 0
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] 322989 0
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] 322989 0
Approximately 20-30 minutes from the time of birth, and recorded within one minute of arrival to the NICU.
Secondary outcome [1] 380438 0
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] 380438 0
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?
No
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] 15949 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 29433 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 305005 0
Hospital
Name [1] 305005 0
Westmead Hospital
Country [1] 305005 0
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] 305361 0
None
Name [1] 305361 0
Address [1] 305361 0
Country [1] 305361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305401 0
Western Sydney Local Health District HREC
Ethics committee address [1] 305401 0
Ethics committee country [1] 305401 0
Australia
Date submitted for ethics approval [1] 305401 0
Approval date [1] 305401 0
04/07/2018
Ethics approval number [1] 305401 0
AU RED HREC/18/WMEAD/192

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100254 0
Dr Pranav Jani
Address 100254 0
Neonatal Intensive Care Unit
Westmead Hospital
Hawkesbury and Darcy Rds
Westmead NSW 2145
Country 100254 0
Australia
Phone 100254 0
+61 2 8890 7375
Fax 100254 0
Email 100254 0
[email protected]
Contact person for public queries
Name 100255 0
Pranav Jani
Address 100255 0
Neonatal Intensive Care Unit
Westmead Hospital
Hawkesbury and Darcy Rds
Westmead NSW 2145
Country 100255 0
Australia
Phone 100255 0
+61 2 8890 7375
Fax 100255 0
Email 100255 0
[email protected]
Contact person for scientific queries
Name 100256 0
Pranav Jani
Address 100256 0
Neonatal Intensive Care Unit
Westmead Hospital
Hawkesbury and Darcy Rds
Westmead NSW 2145
Country 100256 0
Australia
Phone 100256 0
+61 2 8890 7375
Fax 100256 0
Email 100256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
SourceTitleYear of PublicationDOI
Dimensions AITemperature probe placement in very preterm infants during delivery room stabilization: an open-label randomized trial2024https://doi.org/10.1038/s41390-024-03115-5
N.B. These documents automatically identified may not have been verified by the study sponsor.