Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000023954
Ethics application status
Approved
Date submitted
5/01/2011
Date registered
7/01/2011
Date last updated
18/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Neonatal core body temperature extended investigation
Scientific title
Neonatal core body temperature measurement
Secondary ID [1] 253355 0
Nil
Universal Trial Number (UTN)
U1111-1118-8461
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
body temperature 258890 0
Condition category
Condition code
Reproductive Health and Childbirth 259030 259030 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 study of body temperature on critically ill neonates for up to 76 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] 257798 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259880 0
body temperature from 5 sites is recorded every 10 seconds on a battery operated datalogger
Timepoint [1] 259880 0
for up to 76 hours
Secondary outcome [1] 268756 0
Nil
Timepoint [1] 268756 0
Nil

Eligibility
Key inclusion criteria
Critically ill babies >35 weeks GA, and <4 weeks post partum.
Hypoxic Ischaemic Encephalopathy babies or critically ill babies requiring initial ventilator supprt.
Minimum age
No limit
Maximum age
4 Weeks
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
Recruiting
Date of first participant enrolment
Anticipated
15/12/2010
Actual
15/12/2010
Date of last participant enrolment
Anticipated
1/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3530 0
5042

Funding & Sponsors
Funding source category [1] 258273 0
University
Name [1] 258273 0
Flinders University
Country [1] 258273 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 257437 0
Hospital
Name [1] 257437 0
Flinders Medical Centre
Address [1] 257437 0
Flinders Drive
Bedford Park SA 5042
Country [1] 257437 0
Australia
Other collaborator category [1] 251756 0
Hospital
Name [1] 251756 0
Women's & Children's Hospital
Address [1] 251756 0
72 King William Road
North Adelaide SA 5006
Country [1] 251756 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260249 0
The Southern Adelaide Health Service/Flinders University Human Research Ethics Committee
Ethics committee address [1] 260249 0
Room 2A221
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 260249 0
Australia
Date submitted for ethics approval [1] 260249 0
24/09/2010
Approval date [1] 260249 0
24/11/2010
Ethics approval number [1] 260249 0
1/10/0389
Ethics committee name [2] 260250 0
CYWHS Human Research Ethics Committee
Ethics committee address [2] 260250 0
72 King William Street
North Adelaide SA 5006
Ethics committee country [2] 260250 0
Australia
Date submitted for ethics approval [2] 260250 0
23/11/2010
Approval date [2] 260250 0
13/12/2010
Ethics approval number [2] 260250 0
13/12/2332

Summary
Brief summary
Observational study of 5 body temperature sites on critically ill neonates. Hypothesis: that rectal temperature would be slower to respond to changes in environmental temperature than oesophageal temperature.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32054 0
Mr Tony Carlisle
Address 32054 0
PhD student Flinders University GPO Box 2100 Adelaide SA 5001
Country 32054 0
Australia
Phone 32054 0
+61 415 655 502
Fax 32054 0
Email 32054 0
[email protected]
Contact person for public queries
Name 15301 0
Mr Tony Carlisle
Address 15301 0
PhD student
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 15301 0
Australia
Phone 15301 0
+61 (0)415 655 502
Fax 15301 0
Email 15301 0
[email protected]
Contact person for scientific queries
Name 6229 0
Mr Tony Carlisle
Address 6229 0
PhD student
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 6229 0
Australia
Phone 6229 0
0415 655 502
Fax 6229 0
Email 6229 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.