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®).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
41
Dr. Eva Wittenmeier
Mainz, Germany
accuracy of different methods (SpHb, HcHb,BGAHb) of haemoglobin measurement compared with the gold standard labHb
accuracy is assessed by Bland-Altman-method of comparison, by Root mean square error and by out of range
Time frame: through study completion, an average of 3 months
handling of the SpHb-device
measurement of how often the Radical-7 has to be replaced and of the time until a stable Signal appears
Time frame: through study completion, an average of 3 months
influence of weight and gender on accuracy of SpHb
correlation of PI with the accuracy of SpHb
Time frame: through study completion, an average of 3 months
influence of PI (perfusion index) on accuracy of SpHb
correlation of PI with the accuracy of SpHb
Time frame: through study completion, an average of 3 months
influence of concentration of HbF on accuracy of SpHb,BGAHb, HcHb
correlation of concentration of HbF with the accuracy of SpHb
Time frame: through study completion, an average of 3 months
influence of concentration of Hb on accuracy of SpHb,BGAHb, HcHb
correlation of concentration of Hb with the accuracy of SpHb
Time frame: through study completion, an average of 3 months
agreement of concentration of HbF of BGAHb with HbF of labHb
accuracy is assessed by Bland-Altman-method of comparison
Time frame: through study completion, an average of 3 months
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