Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000238572
Ethics application status
Approved
Date submitted
26/02/2015
Date registered
16/03/2015
Date last updated
12/07/2016
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
none
Universal Trial Number (UTN)
U1111-1167-6557
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

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Weeks
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
Uncontrolled

Outcomes
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
None
Timepoint [1] 313232 0
None

Eligibility
Key inclusion criteria
All infants born at or less than 32 weeks gestation
Minimum age
1 Hours
Maximum age
5 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose
Duration
Selection
Timing
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
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/03/2015
Actual
Date of last participant enrolment
Anticipated
27/02/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
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
Country [1] 290831 0
Australia
Primary sponsor type
Individual
Name
Dr Jacqueline Smith
Address
The Townsville Hospital
Neonatal unit
Angus Smith Drive
Douglas
QLD 4814
Country
Australia
Secondary sponsor category [1] 289521 0
Individual
Name [1] 289521 0
Dr Gary Alcock
Address [1] 289521 0
The Townsville Hospital
Neonatal unit
Angus Smith Drive
Douglas
QLD 4814
Country [1] 289521 0
Australia

Ethics approval
Ethics application status
Approved
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
Douglas
Queensland 4814
Ethics committee country [1] 292452 0
Australia
Date submitted for ethics approval [1] 292452 0
Approval date [1] 292452 0
18/12/2014
Ethics approval number [1] 292452 0
HREC/14/QTHS/199

Summary
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

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