Clinical Evaluation of the I-STAT Crea, CG4+ and CG8+ Cartridges Using Neonatal Capillary Whole Blood Specimens with the I-STAT 1 Analyzer
TED
Thomas E. Davis
Principal Investigator
Status: Enrolling By Invitation
Ages: 28 Days
Gender: All Genders
Phase: N/A
2 Locations
Brief Description
The purpose of this voluntary research study is to collect and test heel stick blood samples from neonates either to compare the performance of tests on the i-STAT Crea, CG4+, or CG8+ cartridges to the performance of the same tests with an FDA-cleared device, or to evaluate the precision (accuracy) of the tests.
THIS STUDY IS ENROLLING BY INVITATION ONLY - IU IVD research staff will recieve physician referrals and/or identify potentially eligible neonates (from birth to 28 days of age) who will have measurable levels of the analytes measured by the i-STAT Crea, CG4+, CG8+ cartridge in their blood as part of their normal medical care in order to collect source capillary specimens samples from via heel-stick.
Detailed Description
Participation in this study will involve allowing the collection of 2 capillary specimens (blood sample) from a single heel-stick. Less than 1 teaspoon of blood will be collected by a heel-stick.
- A second heel-stick may be requested if there is an error or a blood sample cannot be obtained from the first heel-stick.
- A maximum of two (2) heel-sticks may be required for participation in this study., which will require approximately 30 minutes of time.
Eligibility of study
Inclusion Criteria
1. Signed and dated parental/legal guardian consent
2. Birth to 28 days of age (neonates)
Exclusion Criteria
1. More than 5% of neonate total blood volume (TBV) has been collected from neonate in the past
24 hours or per institutional protocol
2. Previous enrollment in this study
1. Signed and dated parental/legal guardian consent
2. Birth to 28 days of age (neonates)
Exclusion Criteria
1. More than 5% of neonate total blood volume (TBV) has been collected from neonate in the past
24 hours or per institutional protocol
2. Previous enrollment in this study
Interested in participating?
Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.