Haemoglobin Measurement for Babies

Not Applicable

Completed

• Conditions: Infant; Hemoglobins; Non-invasive
• Interventions: Other: hemoglobin measurement

• 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

Arm && Interventions

Group	Intervention	Description
hemoglobin measurement arm	hemoglobin measurement	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

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