Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000213347
Ethics application status
Approved
Date submitted
2/04/2008
Date registered
18/04/2008
Date last updated
18/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of axillary and tympanic temperature recording in the preterm and term infant
Scientific title
A comparison of axilla and tympanic temperature recording in the preterm and term infant
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temperature 2985 0
Condition category
Condition code
Metabolic and Endocrine 3135 3135 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Temperature taken with:
digital thermometer, electronic thermomater, tympanic thermometer
temperatures will be taken at the allocated care time of each neonate.
Each thermometer will be used one after the other. 1st the digital thermometer, which takes between 2-3 minutes, 2nd tymapnic thermometer, which takes 2 seconds, and 3rd the electronic thermometer which takes 10 seconds.
Duration of the study will be 12 months.
Intervention code [1] 2724 0
Treatment: Devices
Comparator / control treatment
Temperature taking:
Each neonate will have his/her temperature monitored with the 'control' thermometer - digital. This is the thermometer the neonatal unit is currently using for nurisng observations.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4019 0
Accuracy, the Bland and Altman will measure the two devices against the 'control' thermometer. This is a statisticall method for assessing agreement between two methods of clinical measurement.
Timepoint [1] 4019 0
Temperature taken in a 24 hour period. The maximum times the temperature is taken within a 24 hour period is 4 times.
Secondary outcome [1] 6769 0
Enviromental influences, this means what environment the neonate is nursed in, open cot, heated mattress, incubator and incubator with humidity.
Timepoint [1] 6769 0
24 hour period. This will be within the first 24 hours of birth.

Eligibility
Key inclusion criteria
Neonatal population from birth who are admitted to the neoantal unit. Therfore any neonate who is admitted to the unit is elligible to enrol in the trial as long as we have gained parental consent.
Minimum age
24 Weeks
Maximum age
44 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3249 0
Hospital
Name [1] 3249 0
The Townsville Hospital
Country [1] 3249 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
Angus Smith Drive
Douglas TSV QLD 4814
Country
Australia
Secondary sponsor category [1] 2905 0
None
Name [1] 2905 0
Address [1] 2905 0
Country [1] 2905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5233 0
Towsville health service district Human Research Ethics Committee
Ethics committee address [1] 5233 0
Angus Smith Drive
Douglas TSV QLD 4814
Ethics committee country [1] 5233 0
Australia
Date submitted for ethics approval [1] 5233 0
Approval date [1] 5233 0
Ethics approval number [1] 5233 0
11/08

Summary
Brief summary
Measuring temperature is an essential part of nursing care. It has been widely
accepted as an indication of a neonates wellbeing. It can give an early indication of
sepsis, which can be fatal in the neonate.
A comparative descriptive design will be used in preterm and term neonates from
24 to 40 weeks gestation. Three groups will be used<28 weeks,<36 weeks and
>36 weeks. The sample will include any neonate admitted to the unit.
Non-probability convenience sampling will be used. the study will compare the BD
digital thermometer with two trial devices, the Genius 2 infrared tympanic
thermometer and the SureTemp Plus 690 electronic thermometer. Each neonate
on the trial will have thier temperature taken at the allocated 'care time', firstly
using the tympanic thermometer then taking the axilla temperature using the
electronic and digital thermometers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28482 0
Address 28482 0
Country 28482 0
Phone 28482 0
Fax 28482 0
Email 28482 0
Contact person for public queries
Name 11639 0
Jacqueline Smith
Address 11639 0
The Townsville Hospital
Angus Smith Drive
Douglas TSV QLD 4814
Country 11639 0
Australia
Phone 11639 0
+61 7 47963472
Fax 11639 0
Email 11639 0
[email protected]
Contact person for scientific queries
Name 2567 0
Dr Gary Alcock
Address 2567 0
The Townsville Hospital
Angus Smith Drive
Angus Smith Drive
Douglas TSV QLD 4814
Country 2567 0
Australia
Phone 2567 0
+61 7 47963472
Fax 2567 0
Email 2567 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.