Haemoglobin Measurement for Babies

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Non-invasive; Hemoglobins; Infant

Treatments: Other: hemoglobin measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT02722759

Haemoglobin2016

Details and patient eligibility

About

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®).

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 3 days to 4 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

hemoglobin measurement arm

Other group

Description:

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

Treatment:

Other: hemoglobin measurement