The primary objective of this study is to validate the use of a zero-heat flow temperature sensor for the measurement of core body temperature in the NICU by comparing it with 2 other modalities for core temperature measurement.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
n.v.t. het betreft temperatuur bewaking zonder indicatie van aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is to validate the temperature difference between
the ZHF sensor and the temperature of the feedingtube. The difference has to be
less than 0.2 degree.
Secondary outcome
1. Observing the function of the InnerSense feeding tube over time with respect
to feeding periods, feeding quantity and feeding method.
2. Observing the change of temperature per neonate in context of the procedures
performed and the health condition of the neonate.
3. What is the effect of the location of the ZHF sensors on the accuracy of
temperature values measured?
Background summary
The aim is to reduce pain and stress for premature infants at the NICU.
Although core body temperature is a key physiological parameter in the NICU,
current methods of measurements still use adhesive skin probes , that can
affect the comfort of neonates.
The purpose of this clinical investigation is the evaluation of non invasive
sensors (temperature sensor inside the diaper and Zero Heat Flow sensor) in
comparison with standard methods of measuring core temperature. The zero heat
flow (ZHF) technology itself is a novel contactless technology that replaces
uncomfortable probes for core temperature measurement.
The measurements from the ZHF sensors will be compared with the clinical method
that is currently applied: a temperature sensor embedded in the diaper. Since
this method not necessarily displays the core temperature at all times we
include temperature measurements from an Innersense feeding tube. This is a CE
approved commercially available feeding tube for newborn infants that is
equipped with a temperature sensor to obtain the oesophageal temperature that
equals the core temperature. For this study this Innersense tube replaces the
feeding tube that is used presently.
Study objective
The primary objective of this study is to validate the use of a zero-heat flow
temperature sensor for the measurement of core body temperature in the NICU by
comparing it with 2 other modalities for core temperature measurement.
Study design
The plan is to perform a 8h measurement on each neonate (8h hour is the
approximate duration, exact duration will be decided case by case to avoid
interference with the planned workflow). 2 groups of neonates will be
recruited: neonates under 32 weeks of age and neonates above 32 weeks of age.
The first 2 neonates will be recruited in the medium care unit, among neonates
who are using a feeding tube. All neonates recruited will be using a feeding
tube.
As the weight range of neonates is between 500g-5kg and age between 24-42
weeks, we expect to see differences in movement behavior between the neonates.
Therefore we would like to perform measurements on children with different
weights and ages. Measurements will be started on the most stable (thus older
and heavier) neonates. It is likely that during the first measurements
unforeseen problems will arise causing a necessary restart of the system. For
the older neonates this is not a problem or added burden. However the very
small neonates are better left undisturbed; therefore they will form the last
category that will be tested. Data processing will start while measurements are
being conducted. If it is deemed relevant for the study and safe for the
neonates also the more critical (young and low weight) neonates will be
included in this study.
Study burden and risks
The risks of the study have been analyzed. Potential risks have been mitigated
to an acceptable level. A risk analysis document is included in the METC
submission.
High Tech Campus 34
Eindhoven 5656AE
NL
High Tech Campus 34
Eindhoven 5656AE
NL
Listed location countries
Age
Inclusion criteria
Subjects will include neonates in the NICU and the medium care unit. The decision to include a neonate in the study will be made by Prof. dr. S. Bambang Oetomo in consultation with other clinicians at the MMC NICU. Subjects are premature infants born after a gestation of less than 34 weeks.
Exclusion criteria
Neonates who are unstable or suffering from complications (major respiratory problems, low blood pressure, or severe infections) will be excluded from the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41718.015.12 |