Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000862640
Ethics application status
Approved
Date submitted
6/08/2014
Date registered
12/08/2014
Date last updated
12/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Concordance of an Infrared non-contact thermometer via the temporal area with a digital thermometer via the axilla method in preterm and term infants on admission to the Townsville Neonatal Unit.
Scientific title
Concordance of an Infrared non-contact thermometer via the temporal area with a digital thermometer via the axilla method in preterm and term infants on admission to the Townsville Neonatal Unit.
Secondary ID [1] 285114 0
Nil
Universal Trial Number (UTN)
U1111-1160-0858
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temperature 292671 0
Temperature taken via temporal area 292672 0
Condition category
Condition code
Other 292983 292983 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each infant will have his/her temperature taken, first using the digital thermometer under the axilla and then by the infra-red non-contact thermometer via the forehead area.
Only one temperature will be taken and this will be on admission to the neonatal unit.
Intervention code [1] 289963 0
Treatment: Devices
Comparator / control treatment
The use conventional thermometer under the axilla, which is currently in use on the neonatal unit.
Control group
Active

Outcomes
Primary outcome [1] 292842 0
Does the use of the non-contact thermometer agree with the conventional digital thermometer when measuring temperature in the preterm and term infant.
Timepoint [1] 292842 0
The infants temperature will be taken on admission to the neonatal unit
Secondary outcome [1] 309787 0
Nil
Timepoint [1] 309787 0
Nil

Eligibility
Key inclusion criteria
All infants who are born at The Townsville Hospital and are admitted to the neonatal unit
Minimum age
No limit
Maximum age
4 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis
Numerical data will be described using mean and SD or median in interquartile range (IQR) depending on the
distribution.
The Bland and Altman (1986) approach for comparing measurement devices will be utilised for individual
comparison of each thermometer.
In order to detect a mean difference of 0.3C between the axilla and forehead and SD of 0.6, with a power of 80% and 5% level of significance, a sample size of 90 was calculated for each group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
5/02/2014
Date of last participant enrolment
Anticipated
2/02/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2807 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 8496 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 289721 0
Charities/Societies/Foundations
Name [1] 289721 0
Mona Kendall
Country [1] 289721 0
Australia
Primary sponsor type
Individual
Name
Dr Jacqueline Smith NNP
Address
The Townsville hospital
Neonatal unit
Angus Smith Drive
Douglas
Queensland
4814
Country
Australia
Secondary sponsor category [1] 288415 0
None
Name [1] 288415 0
Address [1] 288415 0
Country [1] 288415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291457 0
Human Research Ethics Committee
Ethics committee address [1] 291457 0
Ethics committee country [1] 291457 0
Australia
Date submitted for ethics approval [1] 291457 0
Approval date [1] 291457 0
30/11/2012
Ethics approval number [1] 291457 0
HREC/12/QTHS/172

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

Contacts
Principal investigator
Name 50498 0
Dr Jacqueline Smith NNP
Address 50498 0
The Townsville Hospital
Neonatal Unit
Angus Smith Drive
Douglas
QLD 4814
Country 50498 0
Australia
Phone 50498 0
+61 0422828959
Fax 50498 0
Email 50498 0
[email protected]
Contact person for public queries
Name 50499 0
Jacqueline Smith NNP
Address 50499 0
The Townsville Hospital
Neonatal Unit
Angus Smith Drive
Douglas
QLD 4814
Country 50499 0
Australia
Phone 50499 0
+61 0422828959
Fax 50499 0
Email 50499 0
[email protected]
Contact person for scientific queries
Name 50500 0
Jacqueline Smith
Address 50500 0
The Townsville Hospital
Neonatal Unit
Angus Smith Drive
Douglas
QLD 4814
Country 50500 0
Australia
Phone 50500 0
+61 0422828959
Fax 50500 0
Email 50500 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.