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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Mid-forehead thermometry in Neonatal Intensive Care.
Scientific title
Is Mid-forehead thermometry as accurate as digital axilla in all Neonates admitted to Neonatal Intensive Care Unit?
Secondary ID [1] 263060 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temperature obtained from infra-red mid-forehead thermometry and digital axilla. 270795 0
Condition category
Condition code
Reproductive Health and Childbirth 270989 270989 0 0
Childbirth and postnatal care

Study type
Description of intervention(s) / exposure
Infra-red mid-forehead thermometry.
Measurements to be taken along with digital axilla control at 0800hours and 2000hours for three days. Approximate times only with cue based cares.
Intervention code [1] 269409 0
Early detection / Screening
Intervention code [2] 269426 0
Treatment: Devices
Comparator / control treatment
Digital axilla thermometry.
Control group

Primary outcome [1] 279652 0
Comparison of mid-forehead thermometry readings and accuracy versus current thermometry used, digital axilla.
Timepoint [1] 279652 0
On admission and twice daily for three days.
Secondary outcome [1] 294127 0
Perfusion measurements of foot with infra-red thermometer to assess how well neonates are.
Timepoint [1] 294127 0
With mid-forehead measurements and digital axilla meausurements, twice daily for three days, (and on admission).

Key inclusion criteria
All admissions to Neonatal Intensive Care Unit at Dunedin Public Hospital.
Minimum age
No limit
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Active cooling due to Hypoxic-Ischemic Encephalopathy,
in extremis neoantes & parents of neonates that do not speak English.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All babies admitted to NICU are requested to enroll. All neonates recieve standard digital axilla thermometry and an additional infra-red mid-forehead reading.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3848 0
New Zealand
State/province [1] 3848 0

Funding & Sponsors
Funding source category [1] 269882 0
Name [1] 269882 0
Dunedin Hospital Research Advisory Group Scholarship
Address [1] 269882 0
C/- Dunedin Public Hospital
201 Great King St
City Centre
Dunedin 9016
Country [1] 269882 0
New Zealand
Primary sponsor type
Dunedin Public Hospital
201 Great King St
City Centre
Dunedin 9016
New Zealand
Secondary sponsor category [1] 268898 0
Name [1] 268898 0
Address [1] 268898 0
Country [1] 268898 0
Other collaborator category [1] 252262 0
Name [1] 252262 0
Frances McCaffrey RN
Address [1] 252262 0
Dunedin Public Hospital
C/- 201 Great King St
City Centre
Dunedin 9016
Country [1] 252262 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271851 0
Ethics committee address [1] 271851 0
Ethics committee country [1] 271851 0
Date submitted for ethics approval [1] 271851 0
Approval date [1] 271851 0
Ethics approval number [1] 271851 0

Brief summary
Mid-forehead thermometry is quick and minimally disturbing but has not been validated in literature. Mid-forehead accuracy will be compared in neoantes versus current standard practice of digital axilla thermometry.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 33172 0
Address 33172 0
Country 33172 0
Phone 33172 0
Fax 33172 0
Email 33172 0
Contact person for public queries
Name 16419 0
Joanne Robertson-Smith RN
Address 16419 0
C/- Dunedin Hospital
201 Great King St
City Centre
Dunedin 9016
Country 16419 0
New Zealand
Phone 16419 0
+64 3 4747018
Fax 16419 0
+64 3 4747616
Email 16419 0
Contact person for scientific queries
Name 7347 0
Joanne Robertson-Smith
Address 7347 0
C/- Dunedin Hospital
201 Great King St
City Centre
Dunedin 9016
Country 7347 0
New Zealand
Phone 7347 0
+64 3 4747018
Fax 7347 0
Email 7347 0

No information has been provided regarding IPD availability
Summary results
No Results