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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 : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Eva Wittenmeier:MD, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date  ICMJE March 10, 2016
First Posted Date  ICMJE March 30, 2016
Last Update Posted Date February 25, 2020
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Haemoglobin Measurement for Babies
Official Title  ICMJE Comparison of Alternative Non-invasive and Invasive Methods of Haemoglobin Measuring With the Gold Standard in Preterm and Term Neonates
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®).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Hemoglobins
  • Infant
  • Non-invasive
Intervention  ICMJE Other: hemoglobin measurement
Study Arms  ICMJE 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
Intervention: Other: hemoglobin measurement
Publications * Wittenmeier E, Lesmeister L, Pirlich N, Dette F, Schmidtmann I, Mildenberger E. Assessment of haemoglobin measurement by several methods - blood gas analyser, capillary and venous HemoCue(®) , non-invasive spectrophotometry and laboratory assay - in term and preterm infants. Anaesthesia. 2019 Feb;74(2):197-202. doi: 10.1111/anae.14481. Epub 2018 Nov 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2020)
41
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2016)
80
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 4 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02722759
Other Study ID Numbers  ICMJE Haemoglobin2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Eva Wittenmeier:MD, Johannes Gutenberg University Mainz
Study Sponsor  ICMJE Johannes Gutenberg University Mainz
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Johannes Gutenberg University Mainz
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP