Haemoglobin Measurement for Babies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-10-31

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®).

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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.

Conditions

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Hemoglobins Infant Non-invasive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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hemoglobin measurement arm

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

Group Type OTHER