NCT02722759

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®).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

March 10, 2016

Last Update Submit

February 21, 2020

Conditions

HemoglobinsInfantNon-invasive

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • handling of the SpHb-device

    through study completion, an average of 3 months

  • influence of weight and gender on accuracy of SpHb

    through study completion, an average of 3 months

  • influence of PI (perfusion index) on accuracy of SpHb

    through study completion, an average of 3 months

  • influence of concentration of HbF on accuracy of SpHb,BGAHb, HcHb

    through study completion, an average of 3 months

  • influence of concentration of Hb on accuracy of SpHb,BGAHb, HcHb

    through study completion, an average of 3 months

  • +1 more secondary outcomes

Study Arms (1)

hemoglobin measurement arm

OTHER

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

Other: hemoglobin measurement

Interventions

hemoglobin measurementOTHER
hemoglobin measurement arm

Eligibility Criteria

Age3 Days - 4 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • written informed consent of the parents

You may not qualify if:

  • allergy against sensor patch
  • medical or psychological factors that inhibit a correct finazilation of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Eva Wittenmeier

Mainz, 55131, Germany

Location

Related 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(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.

    PMID: 30427065BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 30, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)