Trials / Completed
CompletedNCT03243266
DxH520 Pediatric Reference Interval Verification
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 290 (actual)
- Sponsor
- Beckman Coulter, Inc. · Industry
- Sex
- All
- Age
- 1 Minute – 21 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | CBC/Diff Reference Interval | Results will not be used to manage patients |
Timeline
- Start date
- 2017-06-19
- Primary completion
- 2018-05-02
- Completion
- 2018-05-02
- First posted
- 2017-08-08
- Last updated
- 2018-07-13
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03243266. Inclusion in this directory is not an endorsement.