Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000700538
Ethics application status
Approved
Date submitted
24/03/2015
Date registered
3/07/2015
Date last updated
12/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Concordance of temperature measurements in the preterm and term infant using oesophageal and axilla method
Scientific title
concordance of the axilla method versus the oesophageal method of temperature taking in preterm and term infants admitted to the neonatal intensive care unit
Secondary ID [1] 286407 0
None
Universal Trial Number (UTN)
U1111-1168-6109
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To ascertain the most efficient and effective way to measure body temperature in preterm and term infants 294563 0
Condition category
Condition code
Reproductive Health and Childbirth 294871 294871 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each infant will have his/her temperature taken. The axilla method will be used at care times as per usual. All infants admitted to the neonatal unit will have a nasal or oral gastric tube inserted. A new device which is a dual lumen NGT/OGT will incorporate a thermistor in the 2nd lumen, which will remain in situ throughout the infant enrollment in the study. This will enable the nurse to have a continuous core temperature measurement which is fed into the computer at the baby's bedside, and the nurse will record each temperature hourly.
Each infant will be enrolled in this study for a maximum of one week minimum duration can be one day.
Intervention code [1] 291478 0
Diagnosis / Prognosis
Comparator / control treatment
The use of the axilla method, which is currently in use on the neonatal unit
Control group
Active

Outcomes
Primary outcome [1] 294621 0
Does the use of oesophageal method of temperature taking agree with the conventional axilla method, when measuring temperature in the preterm and term infant.
Timepoint [1] 294621 0
Each infant will be enrolled in the study for a maximum of one week and a minimum of 24 hours.
Each infant will have his/her core temperature measured every hour by the nurse at the bedside.
Secondary outcome [1] 313731 0
None
Timepoint [1] 313731 0
None

Eligibility
Key inclusion criteria
All infants who are admitted to the neonatal intensive care unit will be eligible for recruitment
Minimum age
No limit
Maximum age
1 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any infants who have a known congenital diaphragmatic hernia, congenital heart disease and anatomical defects which prohibit safe NGT/OGT placement.
Any infants who are on continuous feeds.
Infants who have life threatening congenital abnormalities.

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
Efficacy
Statistical methods / analysis
Numerical data will be described using mean and SD or median interquartile range (IQR) depending on the distribution.
The Bland and Altman (1986) approach for comparing measurement devices will be utilised for individual comparison of each method used.
In order to detect a mean difference of 0.3C between the axilla and oesophageal and SD 0.6, with a power of 80% and 5% level of significance, a sample size of 90 was calculated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/04/2015
Actual
12/04/2015
Date of last participant enrolment
Anticipated
6/03/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3604 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 9393 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 290977 0
Self funded/Unfunded
Name [1] 290977 0
Country [1] 290977 0
Primary sponsor type
Individual
Name
Dr Jacqueline Smith NNP
Address
The Townsville hospital
Neonatal unit
Angus Smith Drive
Douglas
Queensland
4814
Country
Australia
Secondary sponsor category [1] 289654 0
None
Name [1] 289654 0
Address [1] 289654 0
Country [1] 289654 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292569 0
Human research ethics committee
Ethics committee address [1] 292569 0
Townsville hospital health service
Human research ethics committee
Angus smith Drive
Douglas
Townsville
ALD 4814
Ethics committee country [1] 292569 0
Australia
Date submitted for ethics approval [1] 292569 0
Approval date [1] 292569 0
09/12/2014
Ethics approval number [1] 292569 0
HREC/14/QTHS/198

Summary
Brief summary
The study will compare the oesophageal and axilla method of temperature taking and evaluate levels of agreement.
All infants who are admitted to the neonatal intensive care unit, who have parental consent will be eligible for enrolment.
Each infant will have an OGT/NGT inserted which incorporates a thermistor so the clinician can monitor core temperature on a continuous basis.
Infants will also have their axilla temperature taken at the relevant care times.
Each infant will be enrolled in the study for no longer than one week.
We hypothesise at the oesophageal method of temperature taking will be in agreement with the axilla method of temperature taking.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56002 0
Dr Jacqueline Smith
Address 56002 0
The Townsville hospital
Neonatal unit
Angus smith drive
Douglas
QLD 4814
Country 56002 0
Australia
Phone 56002 0
+61 7 4433 3472
Fax 56002 0
Email 56002 0
[email protected]
Contact person for public queries
Name 56003 0
Dr Jacqueline Smith
Address 56003 0
The Townsville Hospital
Neonatal unit
Angus Smith Drive
Douglas
QLD 4814
Country 56003 0
Australia
Phone 56003 0
+61 7 4433 3472
Fax 56003 0
Email 56003 0
[email protected]
Contact person for scientific queries
Name 56004 0
Dr Jacqueline Smith
Address 56004 0
The Townsville Hospital
Neonatal unit
Angus Smith Drive
Douglas
QLD 4814
Country 56004 0
Australia
Phone 56004 0
+61 7 4433 3472
Fax 56004 0
Email 56004 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.