DxH520 Pediatric Reference Interval Verification

Completed

• Conditions: Healthy Subjects
• Interventions: Diagnostic Test: CBC/Diff Reference Interval

• Registration Number: NCT03243266
• Lead Sponsor: Beckman Coulter, Inc.

Brief 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.

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:

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

Study Timeline

• Study Start: 2017-06-19
• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-08
• Primary Completion: 2018-05-02
• Study Completion: 2018-05-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CBC/Diff Reference Interval	CBC/Diff Reference Interval	Hematology routine diagnostic test

Primary Outcome Measures

Name	Time	Method
Pediatric Reference Interval Verification of Hematology CBC/Diff parameters	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.

Trial Locations

Locations (2)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada