Hemoglobins, Infant, Non-invasive
Conditions
Brief summary
In this prospective study different methods of haemoglobin measurement in term and preterm neonates are compared with the gold standard. Non-invasive haemoglobin measurement with the Radical-7® (SpHb, Masimo®), point-of-care haemoglobin-measurement (HcHb, HemoCue@, Radiometer), blood-gas-analysis (BGAHb,ABL800®, Radiometer) are compared with haemoglobin measurement by an automated hematology analyzer (labHb, Siemens Advia®).
Detailed description
Neonates admitted to neonatal intensive care unit or to a normal neonatal ward are enrolled in the study, if parents have given their written informed consent. Non-invasive SpHb measurements are recorded prior to routine venous sampling. Routine venous sampling includes labHb and BGAHb. Additionally HcHb is taken from the routine venous sampling (HcHbart/ven) and from an additionally capillary puncture of earlobe or heel (HcHbcap). Every neonate can participate in two measurements.
Interventions
Sponsors
Johannes Gutenberg University Mainz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Days to 4 Weeks
Healthy volunteers
No
Inclusion criteria
gender both age limits minimum age 3 days of life maximum age 44 postmenstrual weeks accepts no healthy volunteers Inclusion Criteria: written informed consent of the parents \-
Exclusion criteria
* allergy against sensor patch * medical or psychological factors that inhibit a correct finazilation of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| accuracy of different methods (SpHb, HcHb,BGAHb) of haemoglobin measurement compared with the gold standard labHb | through study completion, an average of 3 months | accuracy is assessed by Bland-Altman-method of comparison, by Root mean square error and by out of range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| influence of weight and gender on accuracy of SpHb | through study completion, an average of 3 months | correlation of PI with the accuracy of SpHb |
| influence of PI (perfusion index) on accuracy of SpHb | through study completion, an average of 3 months | correlation of PI with the accuracy of SpHb |
| handling of the SpHb-device | through study completion, an average of 3 months | measurement of how often the Radical-7 has to be replaced and of the time until a stable Signal appears |
| influence of concentration of Hb on accuracy of SpHb,BGAHb, HcHb | through study completion, an average of 3 months | correlation of concentration of Hb with the accuracy of SpHb |
| agreement of concentration of HbF of BGAHb with HbF of labHb | through study completion, an average of 3 months | accuracy is assessed by Bland-Altman-method of comparison |
| influence of concentration of HbF on accuracy of SpHb,BGAHb, HcHb | through study completion, an average of 3 months | correlation of concentration of HbF with the accuracy of SpHb |
Countries
Germany
Outcome results
None listed