NCT02722759

Haemoglobin Measurement for Babies

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 3 Days – 4 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Hemoglobins
• Infant
• Non-invasive

Interventions

Type	Name	Description
OTHER	hemoglobin measurement

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2016-03-30
• Last updated: 2020-02-25

Locations

1 site across 1 country: Germany