Haemoglobin Measurement for Babies

Study Overview
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Brief Summary
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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®).

Detailed Description
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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.

Official Title
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Comparison of Alternative Non-invasive and Invasive Methods of Haemoglobin Measuring With the Gold Standard in Preterm and Term Neonates

Conditions
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Hemoglobins, Infant, Non-invasive

Intervention / Treatment
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* Other: hemoglobin measurement


Participation Criteria
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Eligibility Criteria
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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 - Exclusion Criteria: allergy against sensor patch medical or psychological factors that inhibit a correct finazilation of the study

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 4 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hemoglobin measurement arm<br>In this arm hemoglobin measurement is done by four different devices device Radical-7 for non-invasive measurement of SpHb device HemoCue for taking capillary and venous blood for measurement of HcHb device ABL 800 for measurement of BGAHb device Siemens ADVIA for measurement of labHb For measurement of haemoglobin by the devices the following interventions have to be done: venous or arterial puncture (routine) capillary puncture placing of the Radical 7 sensor | Other: hemoglobin measurement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |