Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611001011976
Ethics application status
Not yet submitted
Date submitted
19/09/2011
Date registered
21/09/2011
Date last updated
21/09/2011
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
Nil
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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).

Eligibility
Key inclusion criteria
All admissions to Neonatal Intensive Care Unit at Dunedin Public Hospital.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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)
Nil
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3848 0
New Zealand
State/province [1] 3848 0
Otago

Funding & Sponsors
Funding source category [1] 269882 0
Hospital
Name [1] 269882 0
Dunedin Hospital Research Advisory Group Scholarship
Country [1] 269882 0
New Zealand
Primary sponsor type
Hospital
Name
Dunedin Public Hospital
Address
201 Great King St
City Centre
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 268898 0
None
Name [1] 268898 0
Address [1] 268898 0
Country [1] 268898 0
Other collaborator category [1] 252262 0
Individual
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
16/09/2011
Approval date [1] 271851 0
Ethics approval number [1] 271851 0

Summary
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

Contacts
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
[email protected]
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
[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.