HemoglobinsNCT02722759
Haemoglobin Measurement for Babies
A study testing hemoglobin measurement in people with Hemoglobins and Infant, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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®… Read more about this study
- Who is it for?
- Ages 3 days to 4 weeks
- Conditions the study is for
- Hemoglobins, Infant, Non-invasive
- What is being tested?
- hemoglobin measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 4 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- written informed consent of the parents
- -
Who cannot join
- allergy against sensor patch
- medical or psychological factors that inhibit a correct finazilation of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Alternative Non-invasive and Invasive Methods of Haemoglobin Measuring With the Gold Standard in Preterm and Term Neonates
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®).
Read the 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
- Being tested
- hemoglobin measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemoglobin measurementOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: hemoglobin measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 3 months
Secondary outcomes (6)
handling of the SpHb-device
measurement of how often the Radical-7 has to be replaced and of the time until a stable Signal appears
Measured: through study completion, an average of 3 months
influence of weight and gender on accuracy of SpHb
correlation of PI with the accuracy of SpHb
Measured: through study completion, an average of 3 months
influence of PI (perfusion index) on accuracy of SpHb
correlation of PI with the accuracy of SpHb
Measured: through study completion, an average of 3 months
influence of concentration of HbF on accuracy of SpHb,BGAHb, HcHb
correlation of concentration of HbF with the accuracy of SpHb
Measured: through study completion, an average of 3 months
influence of concentration of Hb on accuracy of SpHb,BGAHb, HcHb
correlation of concentration of Hb with the accuracy of SpHb
Measured: through study completion, an average of 3 months
agreement of concentration of HbF of BGAHb with HbF of labHb
accuracy is assessed by Bland-Altman-method of comparison
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemoglobinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Eva Wittenmeier:MD, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722759
- Sponsor's protocol ID
- Haemoglobin2016
- Status last verified
- Feb 2020
- First submitted
- 10 Mar 2016
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30427065
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Alternative Non-invasive and Invasive Methods of Haemoglobin Measuring With the Gold Standard in Preterm and Term Neonates
- ClinicalTrials.gov ID
- NCT02722759
- Acronym / sponsor ID
- Haemoglobin2016
- Conditions
- Hemoglobins, Infant, Non-invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hemoglobin measurement arm | Other | Other: hemoglobin measurementIn 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 |
Who may qualify
- Ages
- 3 days to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- written informed consent of the parents
- -
Key exclusion criteria (2 listed)
- allergy against sensor patch
- medical or psychological factors that inhibit a correct finazilation of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemoglobin measurement | Other | hemoglobin measurement arm |
Primary outcome
accuracy of different methods (SpHb, HcHb,BGAHb) of haemoglobin measurement compared with the gold standard labHb
Time frame: 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
6 secondary outcomes
handling of the SpHb-device
Time frame: through study completion, an average of 3 months
influence of weight and gender on accuracy of SpHb
Time frame: through study completion, an average of 3 months
influence of PI (perfusion index) on accuracy of SpHb
Time frame: through study completion, an average of 3 months
influence of concentration of HbF on accuracy of SpHb,BGAHb, HcHb
Time frame: through study completion, an average of 3 months
influence of concentration of Hb on accuracy of SpHb,BGAHb, HcHb
Time frame: through study completion, an average of 3 months
agreement of concentration of HbF of BGAHb with HbF of labHb
Time frame: through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 30427065Wittenmeier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemoglobin measurement in people with Hemoglobins and Infant, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of different methods (SpHb, HcHb,BGAHb) of haemoglobin measurement compared with the gold standard labHb (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.