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Completed

NCT Number: NCT02722759

Haemoglobin Measurement for Babies

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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Key information

Conditions

Hemoglobins Infant Non-invasive

Age range

3 day–4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Eva Wittenmeier

Mainz, 55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hemoglobin measurement

Other

Primary outcomes

  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, by Root mean square error and by out of range

Secondary outcomes

  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 and of the time until a stable Signal appears

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 30, 2016
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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