Clinical trial NCT02722759: Haemoglobin Measurement for Babies
Official title: Comparison of Alternative Non-invasive and Invasive Methods of Haemoglobin Measuring With the Gold Standard in Preterm and Term Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemoglobins
Infant
Non-invasive
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 41
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: accuracy of different methods (SpHb, HcHb,BGAHb) of haemoglobin measurement compared with the gold standard labHb
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: handling of the SpHb-device
timeFrame: through study completion, an average of 3 months
measure: influence of weight and gender on accuracy of SpHb
timeFrame: through study completion, an average of 3 months
measure: influence of PI (perfusion index) on accuracy of SpHb
timeFrame: through study completion, an average of 3 months
measure: influence of concentration of HbF on accuracy of SpHb,BGAHb, HcHb
timeFrame: through study completion, an average of 3 months
measure: influence of concentration of Hb on accuracy of SpHb,BGAHb, HcHb
timeFrame: through study completion, an average of 3 months
measure: agreement of concentration of HbF of BGAHb with HbF of labHb
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Dr. Eva Wittenmeier
Study officials:
References:
citation: 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(R) , 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.