DxH520 Pediatric Reference Interval Verification

Healthy Subjects Clinical Trial

Official title:

DxH520 Pediatric Reference Interval Verification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243266
• Other study ID #: B90590
• Status: Completed
• Start date: June 19, 2017
• Est. completion date: May 2, 2018

Study information

• Verified date: July 2018
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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:

1. Neonate: 0 to 30 days

2. Infant: > 30 days to 2 years

3. Child: 3 years to 12 years

4. Adolescent: 13 years to 21 years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Diagnostic Test:
• CBC/Diff Reference Interval
Results will not be used to manage patients

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day