Haemoglobin Measurement for Babies

February 21, 2020 updated by: Dr. Eva Wittenmeier:MD, Johannes Gutenberg University Mainz

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

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®).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55131
        • Dr. Eva Wittenmeier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: hemoglobin measurement

What is the study measuring?

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
Time Frame: through study completion, an average of 3 months
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
Time Frame: through study completion, an average of 3 months
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
Time Frame: through study completion, an average of 3 months
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
Time Frame: through study completion, an average of 3 months
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
Time Frame: through study completion, an average of 3 months
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
Time Frame: through study completion, an average of 3 months
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
Time Frame: through study completion, an average of 3 months
accuracy is assessed by Bland-Altman-method of comparison
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimate)

March 30, 2016

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Haemoglobin2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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