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Haemoglobin Measurement for Babies

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ClinicalTrials.gov Identifier: NCT02722759
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Eva Wittenmeier, Johannes Gutenberg University Mainz

Brief Summary:
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®).

Condition or disease Intervention/treatment Phase
Hemoglobins Infant Non-invasive Other: hemoglobin measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Alternative Non-invasive and Invasive Methods of Haemoglobin Measuring With the Gold Standard in Preterm and Term Neonates
Actual Study Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

gender both

age limits minimum age 1 day maximum age 4 weeks

accepts no healthy volunteers

Inclusion Criteria:

written informed consent of the parents

-

Exclusion Criteria:

  • allergy against sensor patch

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722759


Locations
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Germany
Dr. Eva Wittenmeier
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz

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Responsible Party: Dr. Eva Wittenmeier, Principal Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02722759     History of Changes
Other Study ID Numbers: Haemoglobin2016
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No