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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.
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Scientific title
Is Mid-forehead thermometry as accurate as digital axilla in all Neonates admitted to Neonatal Intensive Care Unit?
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Secondary ID [1]
263060
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Temperature obtained from infra-red mid-forehead thermometry and digital axilla.
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Condition category
Condition code
Reproductive Health and Childbirth
270989
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0
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
269409
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Early detection / Screening
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Intervention code [2]
269426
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Treatment: Devices
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Comparator / control treatment
Digital axilla thermometry.
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Control group
Active
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Outcomes
Primary outcome [1]
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Comparison of mid-forehead thermometry readings and accuracy versus current thermometry used, digital axilla.
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Assessment method [1]
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Timepoint [1]
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On admission and twice daily for three days.
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Secondary outcome [1]
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Perfusion measurements of foot with infra-red thermometer to assess how well neonates are.
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Assessment method [1]
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Timepoint [1]
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With mid-forehead measurements and digital axilla meausurements, twice daily for three days, (and on admission).
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Eligibility
Key inclusion criteria
All admissions to Neonatal Intensive Care Unit at Dunedin Public Hospital.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Active cooling due to Hypoxic-Ischemic Encephalopathy,
in extremis neoantes & parents of neonates that do not speak English.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3848
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New Zealand
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State/province [1]
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Otago
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Funding & Sponsors
Funding source category [1]
269882
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Hospital
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Name [1]
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Dunedin Hospital Research Advisory Group Scholarship
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Address [1]
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C/- Dunedin Public Hospital
201 Great King St
City Centre
Dunedin 9016
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Country [1]
269882
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New Zealand
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Primary sponsor type
Hospital
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Name
Dunedin Public Hospital
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Address
201 Great King St
City Centre
Dunedin 9016
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
268898
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Other collaborator category [1]
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Individual
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Name [1]
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Frances McCaffrey RN
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Address [1]
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Dunedin Public Hospital
C/- 201 Great King St
City Centre
Dunedin 9016
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Country [1]
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New Zealand
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Ethics committee address [1]
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Ethics committee country [1]
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Date submitted for ethics approval [1]
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16/09/2011
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Approval date [1]
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Ethics approval number [1]
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Joanne Robertson-Smith RN
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Address
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C/- Dunedin Hospital
201 Great King St
City Centre
Dunedin 9016
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Country
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New Zealand
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Phone
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+64 3 4747018
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Fax
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+64 3 4747616
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Email
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[email protected]
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Contact person for scientific queries
Name
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Joanne Robertson-Smith
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Address
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C/- Dunedin Hospital
201 Great King St
City Centre
Dunedin 9016
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Country
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New Zealand
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Phone
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+64 3 4747018
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Fax
7347
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Email
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[email protected]
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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.
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