Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000137998
Ethics application status
Approved
Date submitted
6/02/2011
Date registered
7/02/2011
Date last updated
7/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Neonatal Core body temperature investigation
Scientific title
Neonatal core body temperature measurement: a pilot study
Secondary ID [1] 253554 0
Nil
Universal Trial Number (UTN)
U1111-1119-3435
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
body temperature 261114 0
Condition category
Condition code
Reproductive Health and Childbirth 259261 259261 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational pilot study of body temperature on critically ill neonates for up to 24 hours. Rectal, Oesophageal, non-invasive thoracic (middlle of the back in contact with the mattress), non-invasive head (middlle of the head in contact with the mattress) and exposed abdominal skin temperatures are recorded on an a battery operated datalogger every 10 seconds.
Intervention code [1] 257984 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262075 0
body temperature from 5 sites is recorded every 10 seconds on a battery operated datalogger
Timepoint [1] 262075 0
for up to 24 hours
Secondary outcome [1] 273100 0
Nil
Timepoint [1] 273100 0
Nil

Eligibility
Key inclusion criteria
Critically ill babies >35 weeks GA requiring ventilator support
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Rectal or Oesophageal atresia.
less than 35 weeks GA

Study design
Purpose
Duration
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258438 0
University
Name [1] 258438 0
Flinders University
Country [1] 258438 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 257584 0
Hospital
Name [1] 257584 0
Flinders Medical Centre
Address [1] 257584 0
Flinders Drive
Bedford Park SA 5042
Country [1] 257584 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260426 0
The Southern Adelaide Health Service/Flinders University Human Research Ethics Committee
Ethics committee address [1] 260426 0
Room 2A221
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 260426 0
Australia
Date submitted for ethics approval [1] 260426 0
02/11/2009
Approval date [1] 260426 0
16/12/2009
Ethics approval number [1] 260426 0
1/09/0348

Summary
Brief summary
Pilot observational study of 5 body temperature sites on critically ill neonates.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32178 0
Address 32178 0
Country 32178 0
Phone 32178 0
Fax 32178 0
Email 32178 0
Contact person for public queries
Name 15425 0
Tony Carlisle
Address 15425 0
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 15425 0
Australia
Phone 15425 0
+61 (0)415 655 502
Fax 15425 0
Email 15425 0
[email protected]
Contact person for scientific queries
Name 6353 0
Tony Carlisle
Address 6353 0
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 6353 0
Australia
Phone 6353 0
+61 (0)415 655 502
Fax 6353 0
Email 6353 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.