DxH520 Pediatric Reference Interval Verification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-19

Study Completion Date

2018-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Micro-hematology Analyzer for Viral/Bacterial Description

NCT05090319

Infection Viral Infection, Bacterial

UNKNOWN

Procalcitonin Test Reference Range Determination

NCT02591121

Healthy

COMPLETED

Clinical Study of a Novel Hemolysis Point of Care Test at an Emergency Department.

NCT02976610

Hemolysis Blood Specimen Collection

COMPLETED NA

Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population

NCT04889937

Hematologic Malignancy

COMPLETED

Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge

NCT03152461

Blood Loss, Surgical

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBC/Diff Reference Interval

Hematology routine diagnostic test

CBC/Diff Reference Interval

Intervention Type DIAGNOSTIC_TEST

Results will not be used to manage patients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBC/Diff Reference Interval

Results will not be used to manage patients

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Minute

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes