Healthy SubjectsNCT03243266
DxH520 Pediatric Reference Interval Verification
An observational study of Healthy Subjects, run by Beckman Coulter, Inc. at 2 sites in Canada.
Trial summary
Results from this study will be used to verify that the published pediatric reference intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges. Read more about this study
- Who is it for?
- Ages 1 minute to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- CBC/Diff Reference Interval
- How many people
- 290 participants
- Where
- 2 sitesCanada
- Study dates
- 19 Jun 2017to 2 May 2018
- Phase
- Observational
- 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 1 minute to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric specimens from apparently healthy children
Who may be able to join
- All subject genders, race and ethnicity will be included in the study. Pediatric samples will be targeted for this study within the specified age ranges.
- Specimens should be from apparently healthy individuals.
- Samples from inpatient and ED visits maybe included if they are confirmed to be the final CBC before discharge and the patient had a non-hematological diagnosis
Who cannot join
- Samples originating from a hematology/oncology clinic (both inpatient and outpatient)
- Samples originating from a patient with a hematological disorder or diagnosis
- Samples from the Neonatal Intensive Care Unit that are not the last specimens collected prior to discharge
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Alberta Children's Hospital
Calgary, Alberta, T2N 2T9
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Results from this study will be used to verify that the published pediatric reference intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.
Read the detailed description
Pediatric specimens from each age range will be tested from apparently healthy children. Ten male and Ten female are required for each age range. The values will be assessed against published reference ranges to verify that the values obtained fall within the expected reference interval for the age ranges listed below:
- Neonate: 0 to 30 days
- Infant: > 30 days to 2 years
- Child: 3 years to 12 years
- Adolescent: 13 years to 21 years
- Conditions
- Healthy Subjects
- Being tested
- CBC/Diff Reference Interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC/Diff Reference IntervalDiagnostic test
Results will not be used to manage patients
| Study group | Role | What they receive |
|---|---|---|
| CBC/Diff Reference Interval | Hematology routine diagnostic test Receives: Diagnostic Test: CBC/Diff Reference Interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Reference Interval Verification of Hematology CBC/Diff parameters
Verify Reference Intervals of Hematology CBC/Diff parameters in pediatric age groups. The blood cell count test parameters to be verified are:
White Blood Cells (x10^3/µL), Red Blood Cells (x10^6/µL), Hemoglobin (g/dL), Hematocrit %, Mean Corpuscular Hemoglobin (pg), Mean Corpuscular Hemoglobin Concentration (g/dL), Mean Corpuscular Volume (fL), Red Cell Distribution Width-CV (%) Red cell Distribution Width-SD (fL), Platelets (x10^3/µL), Mean Platelet Volume (fL), Neutrophil %, Neutrophil Count (x10^3/µL), Lymphocyte %, Lymphocyte Count (x10^3/µL), Monocyte %, Monocyte Count (x10^3/µL), Eosinophil %, Eosinophil Count (x10^3/µL), Basophil %, Basophil Count (x10^3/µL). Study results will be analyzed following CLSI guideline EP28-A3c.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start19 Jun 2017
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khosrow Adeli, Ph.D, Principal investigator, The Hospital for Sick ChildrenMeer-Taher Shabani-Rad, MD, Principal investigator, Alberta Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243266
- Sponsor's protocol ID
- B90590
- Status last verified
- Jul 2018
- First submitted
- 28 Jul 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DxH520 Pediatric Reference Interval Verification
- ClinicalTrials.gov ID
- NCT03243266
- Acronym / sponsor ID
- B90590
- Conditions
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 8 Aug 2017 (actual)
- 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.
Results from this study will be used to verify that the published pediatric reference intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.
Detailed description
Pediatric specimens from each age range will be tested from apparently healthy children. Ten male and Ten female are required for each age range. The values will be assessed against published reference ranges to verify that the values obtained fall within the expected reference interval for the age ranges listed below:
- Neonate: 0 to 30 days
- Infant: > 30 days to 2 years
- Child: 3 years to 12 years
- Adolescent: 13 years to 21 years
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBC/Diff Reference Interval | – | Diagnostic Test: CBC/Diff Reference IntervalHematology routine diagnostic test |
Who may qualify
- Ages
- 1 minute to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric specimens from apparently healthy children
Key inclusion criteria (3 listed)
- All subject genders, race and ethnicity will be included in the study. Pediatric samples will be targeted for this study within the specified age ranges.
- Specimens should be from apparently healthy individuals.
- Samples from inpatient and ED visits maybe included if they are confirmed to be the final CBC before discharge and the patient had a non-hematological diagnosis
Key exclusion criteria (3 listed)
- Samples originating from a hematology/oncology clinic (both inpatient and outpatient)
- Samples originating from a patient with a hematological disorder or diagnosis
- Samples from the Neonatal Intensive Care Unit that are not the last specimens collected prior to discharge
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 |
|---|---|---|
| CBC/Diff Reference IntervalResults will not be used to manage patients | Diagnostic test | CBC/Diff Reference Interval |
Primary outcome
Pediatric Reference Interval Verification of Hematology CBC/Diff parameters
Time frame: 1 day
Verify Reference Intervals of Hematology CBC/Diff parameters in pediatric age groups. The blood cell count test parameters to be verified are: White Blood Cells (x10^3/µL), Red Blood Cells (x10^6/µL), Hemoglobin (g/dL), Hematocrit %, Mean Corpuscular Hemoglobin (pg), Mean Corpuscular Hemoglobin Concentration (g/dL), Mean Corpuscular Volume (fL), Red Cell Distribution Width-CV (%) Red cell Distribution Width-SD (fL), Platelets (x10^3/µL), Mean Platelet Volume (fL), Neutrophil %, Neutrophil Count (x10^3/µL), Lymphocyte %, Lymphocyte Count (x10^3/µL), Monocyte %, Monocyte Count (x10^3/µL), Eosinophil %, Eosinophil Count (x10^3/µL), Basophil %, Basophil Count (x10^3/µL). Study results will be analyzed following CLSI guideline EP28-A3c.
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 13 Jul 2018.
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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.
Khosrow Adeli, Ph.D principal investigator
The Hospital for Sick Children
Meer-Taher Shabani-Rad, MD principal investigator
Alberta Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects, run by Beckman Coulter, Inc. at 2 sites in Canada.
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 3 inclusion and 3 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Pediatric Reference Interval Verification of Hematology CBC/Diff parameters (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2018.