Haemoglobin Measurement for Babies

Not Applicable

Completed

• Conditions: Infant; Hemoglobins; Non-invasive

• Registration Number: NCT02722759
• Lead Sponsor: 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®).

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
accuracy of different methods (SpHb, HcHb,BGAHb) of haemoglobin measurement compared with the gold standard labHb	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 Outcome Measures

Name	Time	Method
handling of the SpHb-device	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	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	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	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	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	through study completion, an average of 3 months	accuracy is assessed by Bland-Altman-method of comparison

Trial Locations

Locations (1)

Dr. Eva Wittenmeier; 🇩🇪 Mainz, Germany