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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Core and peripheral temperature gradient as a marker for infection in the newborn premature infant.
Scientific title
Core and peripheral temperature gradient as a marker for infection in the newborn infant.
Secondary ID [1] 286272 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infection 294337 0
Prematurity 294338 0
Condition category
Condition code
Infection 294654 294654 0 0
Other infectious diseases
Reproductive Health and Childbirth 294720 294720 0 0
Complications of newborn

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Each infant who is born at 32 weeks gestation or less, admitted to the neonatal intensive care unit and enrolled in the study will have a feeding tube inserted (InnerSense oesophageal temperature probe and feeding tube). InnerSense has a thermistor in the 2nd lumen, which will monitor the core temperature of the infant. The infant will also have a thermistor probe attached to the sole of the foot, which will measure the peripheral temperature. Each infant enrolled in the study will have the device in situ from birth to four weeks. Temperature will be recorded from this device and from the thermistor on the foot, on a continuous 24 hour basis, all data is fed through the the monitor at the infants bedside.
Intervention code [1] 291294 0
Not applicable
Comparator / control treatment
No control
Control group

Primary outcome [1] 294411 0
Our primary outcome is to see if there is an association between an alteration in core temperature (an increase) and peripheral temperature (a decrease) and the diagnosis of infection.
Other tests which will be used are observations by the clinical nurse and blood tests, which include, FBC, CRP and blood culture.
A positive blood culture will be used as the gold standard for confirmation of infection in the premature infant.
Timepoint [1] 294411 0
From birth to four weeks of age (this will cover early and late sepsis). Temperature will be measured on a continuous 24 hour basis, therefore outcome will be measured continuously until the device is removed, after four weeks.
Secondary outcome [1] 313232 0
Timepoint [1] 313232 0

Key inclusion criteria
All infants born at or less than 32 weeks gestation
Minimum age
1 Hours
Maximum age
5 Weeks
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Not consented
skin problems
infants with diaphragmatic hernia, congenital heart disease, and any anatomical defects that prohibit safe nasogastric or orogastric device placement and oesophageal disorders and defects.

Study design
Statistical methods / analysis
The number of participants needed to achieve the study objectives has not yet been determined. We will commence recruitment and once we have enrolled 20, the statistician will calculate numbers needed to achieve study objectives and statistical assumptions.
SPSS will be utilised of the analysis of data
Numerical data will be described using mean and SD or median inter-quartile range (IQR) depending on the distribution
To record the percentage of infants who have an alteration in the core-peripheral temperature gradient and proven sepsis, as per positive blood culture.
Other relevant methods to analyse data will be determined by the statistician.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 3523 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 9286 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 290831 0
Government body
Name [1] 290831 0
Visiting Medical officer Fund
Queensland Health
Address [1] 290831 0
VMO Fund
c/o Chief Human Resources Officer
Level 15 QHB 147 - 163 Charlotte Street
QLD 4000
Country [1] 290831 0
Primary sponsor type
Dr Jacqueline Smith
The Townsville Hospital
Neonatal unit
Angus Smith Drive
QLD 4814
Secondary sponsor category [1] 289521 0
Name [1] 289521 0
Dr Gary Alcock
Address [1] 289521 0
The Townsville Hospital
Neonatal unit
Angus Smith Drive
QLD 4814
Country [1] 289521 0

Ethics approval
Ethics application status
Ethics committee name [1] 292452 0
Human research Ethics Committee
Ethics committee address [1] 292452 0
Townsville Hospital and Health Service
Human Research Ethics Committee
100 Angus smith Drive
Queensland 4814
Ethics committee country [1] 292452 0
Date submitted for ethics approval [1] 292452 0
Approval date [1] 292452 0
Ethics approval number [1] 292452 0

Brief summary
Diagnosing neonatal infection, whether early or late , can be challenging as there is no one ‘gold standard’ test (Srinivansan and Harris, 2012). Failure to diagnose infection in the newborn infant in a timely manner can lead to higher death and illness rates (Carcillo, 2006).
Continued surveillance to monitor changes in the infants condition is also paramount to distinguish between infants with an infection and non-infected infants. One way, which may help in the diagnosis of infection in the newborn premature infant is by measuring the body temperature and the skin temperature of the foot, on a continuous basis.All babies who are born at or before 32 weeks gestation are eligible for the study. If you have given consent for your baby to be part of this study your baby will have temperature measured by a small probe, which is placed on the sole of the foot, a small thermometer which is incorporated into the gastric tube ( all infants born and admitted to the neonatal unit will have one of these placed). This tube is mainly used for two things, to vent the stomach to prevent build up of gas and to feed baby when ready. Your baby will also have a temperature which is measured under the arm. We will collect information from your baby’s notes and observation charts. Information which will be recorded and used in the study will be gender, antenatal history, birth score , gestational age, birth weight, temperature, blood test results and type of environment your baby is nursed in.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 55350 0
Dr Jacqueline Smith
Address 55350 0
The Townsville Hospital
Neonatal Unit
Angus Smith Drive
QLD 4814
Country 55350 0
Phone 55350 0
+61 7 4433 3472
Fax 55350 0
Email 55350 0
Contact person for public queries
Name 55351 0
Dr Jacqueline Smith
Address 55351 0
The Townsville Hospital
Neonatal Unit
Angus Smith Drive
QLD 4814
Country 55351 0
Phone 55351 0
+61 422828959
Fax 55351 0
Email 55351 0
Contact person for scientific queries
Name 55352 0
Dr Gary Alcock
Address 55352 0
The Townsville Hospital
Neonatal Unit
Angus Smith Drive
QLD 4814
Country 55352 0
Phone 55352 0
+61 4433 3472
Fax 55352 0
Email 55352 0

No information has been provided regarding IPD availability
Summary results
No Results