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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hemoglobin measurement arm | Other | In this arm hemoglobin measurement is done by four different devices
For measurement of haemoglobin by the devices the following interventions have to be done:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hemoglobin measurement | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 3 months |
| influence of weight and gender on accuracy of SpHb |
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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
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Eva Wittenmeier | Mainz | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30427065 | Background | Wittenmeier E, Lesmeister L, Pirlich N, Dette F, Schmidtmann I, Mildenberger E. Assessment of haemoglobin measurement by several methods - blood gas analyser, capillary and venous HemoCue(R) , non-invasive spectrophotometry and laboratory assay - in term and preterm infants. Anaesthesia. 2019 Feb;74(2):197-202. doi: 10.1111/anae.14481. Epub 2018 Nov 14. |
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correlation of PI with the accuracy of SpHb
| 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 | 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 | 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 | 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 | through study completion, an average of 3 months |