Core and peripheral temperature gradient as a marker for infection in the newborn premature infant.

Core and peripheral temperature gradient as a marker for infection in the newborn infant.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12615000238572

Enrollment

150

Registered

2015-03-16

Start date

2015-03-23

Completion date

2017-02-27

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

1 Hours to 5 Weeks

Healthy volunteers

Inclusion criteria

All infants born at or less than 32 weeks gestation

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.

Outcome results