Haemoglobin Measurement for Babies

Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722759
• Other study ID #: Haemoglobin2016
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: February 2020
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Hemoglobins
• Infant
• Non-invasive

Intervention

Other:
• hemoglobin measurement

Locations

Country	Name	City	State
Germany	Dr. Eva Wittenmeier	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of different methods (SpHb, HcHb,BGAHb) of haemoglobin measurement compared with the gold standard labHb	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	handling of the SpHb-device	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
Secondary	influence of weight and gender on accuracy of SpHb	correlation of PI with the accuracy of SpHb	through study completion, an average of 3 months
Secondary	influence of PI (perfusion index) on accuracy of SpHb	correlation of PI with the accuracy of SpHb	through study completion, an average of 3 months
Secondary	influence of concentration of HbF on accuracy of SpHb,BGAHb, HcHb	correlation of concentration of HbF with the accuracy of SpHb	through study completion, an average of 3 months
Secondary	influence of concentration of Hb on accuracy of SpHb,BGAHb, HcHb	correlation of concentration of Hb with the accuracy of SpHb	through study completion, an average of 3 months
Secondary	agreement of concentration of HbF of BGAHb with HbF of labHb	accuracy is assessed by Bland-Altman-method of comparison	through study completion, an average of 3 months