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Haemoglobin Measurement for Babies

J

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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