In this study, we will investigate the use of optical spectroscopy in determining neonatal bilirubin and hemoglobin blood levels. The outcome and accuracy of the optical spectroscopy measurements will be compared to the outcome of laboratory blood…
ID
Source
Brief title
Condition
- Haematological disorders NEC
- Metabolism disorders NEC
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The bilirubin and hemoglobin concentrations in the skin and the blood vessels
in the skin.
Secondary outcome
Influence of age, influence of measurement site, influence of skin thickness,
influence of skin type.
Background summary
Neonatal bilirubin and hemoglobin blood levels are measured by laboratory blood
analysis, after invasive blood sampling. This is an invasive and time consuming
procedure, causing a relatively large time interval between the moment
treatment is needed and the time of blood sampling. Complications as a result
of invasive blood sampling (pain, inflammation, cutaneous calcifications) are
often observed in preterm neonates, who require close monitoring of body
function to prevent hyperbilirubinemia, anemia and hypoxia. Neonates at the
intensive care require up to 5 heel sticks a day.
Optical spectroscopy possibly offers an alternative for measuring bilirubin and
hemoglobin levels. In comparison to blood sampling, optical spectroscopy is a
non-invasive technique and offers the possibility of monitoring (real-time
measuring) blood levels.
Study objective
In this study, we will investigate the use of optical spectroscopy in
determining neonatal bilirubin and hemoglobin blood levels. The outcome and
accuracy of the optical spectroscopy measurements will be compared to the
outcome of laboratory blood analysis.
Results will be used to validate and further develop the technique.
Study design
In this pilot study, we will measure neonates at the neonatology department at
the AMC to determine the main factors of influence on the determination of
bilirubin and hemoglobin levels with optical spectroscopy. Currently, it is not
clear which factors are of influence on this determination. We expect influence
of: skin type, skin thickness, measurement site on the body, gestational age
and age after birth. We will perform a spectroscopy measurement on a patient
each time an invasive blood analysis is carried out, for other reasons than
this study. The measurements with optical spectroscopy will be compared to the
bilirubin and hemoglobin levels from invasive blood analysis. Therefore it is
important to perform the measurements directly before, or after blood sampling.
In addition to the spectroscopy measurements, we perform a skinfold measurement
at the upper arm to determine skin thickness.
Study burden and risks
There are no burdens and risks.
Meibergdreef 9
1105AZ Amsterdam
Nederland
Meibergdreef 9
1105AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Known bilirubin and/or hemoglobin blood levels from invasive blood analysis (blood drawn for other reasons than this study).
Exclusion criteria
Unknown bilirubin and hemoglobin levels.
Affections that hamper the practical feasibility of the measurements (skin irritations etc.).
Observable resistance or discomfort during the measurements for the patient (e.g. increased stress levels).
The latter two criteria will be judged by the treating physician and compared to the guidelines of the behavioural code of the Nederlandse Vereniging voor Kindergeneeskunde.
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 | NL27442.018.09 |