Healthy and Unhealthy Neonates Clinical Trial
Official title:
Performance Study of Nova StatStrip® Blood Glucose Monitoring Test System on Neonatal Capillary Blood
| Verified date | April 2024 |
| Source | Nova Biomedical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is to determine the validity of Nova StatStrip® blood glucose monitoring test system including the Nova StatStrip® glucose hospital meter and test strips in measuring Chinese neonatal capillary blood glucose levels by evaluating how the results compare to those obtained from laboratory hexokinase method. The study results will be the basis for the regulatory submission and registration of the Nova StatStrip® glucose hospital meter and test strips in testing the neonatal capillary whole blood specimens to the China Food and Drug Administration (CFDA). Good clinical practice indicates that the performance of a point-of-care glucose monitoring test system be validated before clinical use. It is therefore important to perform a method comparison study to determine how the results obtained from a type of glucose monitoring test system compare to those from a laboratory hexokinase method.
| Status | Suspended |
| Enrollment | 120 |
| Est. completion date | March 30, 2025 |
| Est. primary completion date | March 30, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 0 Days to 28 Days |
| Eligibility | Inclusion Criteria: - Subject is within 28 days after birth. - The legal representative of the Subject agrees to sign two copies of the Informed Consent Form. - The Subject's capillary whole blood needs to be drawn via heel stick for routine clinical laboratory testing according to the prescription. - The legal representative of the Subject agrees that the Subject provides 300 µL capillary whole blood for glucose and haematocrit testing in addition to routine clinical laboratory testing. Exclusion Criteria: - Subject/legal representative is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products; - Subject has already participated in this study. |
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai General Hospital | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Nova Biomedical |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | blood glucose level measured by StatStrip blood glucose meter | 6 months | ||
| Primary | plasma glucose level measured by a laboratory biochemistry analyzer | 6 months | ||
| Secondary | hematocrit of the heel-stick blood | 6 months |