Clinical Evaluation of the i-STAT Crea, CG4+ and CG8+ Cartridges using Neonatal Capillary Whole Blood Specimens with the i-STAT 1 Analyzer
Study on Blood Test Accuracy in Newborns
Thomas E. Davis
Primary Investigator
Brief description of study
Detailed description of study
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
You may be eligible for this study if you meet the following criteria:
- Conditions: all
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Age: 28 days or below
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Gender: All
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
This study investigates the accuracy and comparison of blood tests using special cartridges in newborn babies. A cartridge is a small container used to hold the blood sample for testing. The purpose of this study is to see how well these cartridges work compared to a device already approved by the FDA. The tests will be done on blood samples taken from the newborn's heel, which is called a heel-stick.
In this study, two small blood samples will be collected from a single heel-stick. If there is an error or the first sample cannot be obtained, a second heel-stick may be needed. The amount of blood taken is less than a teaspoon, and the whole process will take about 30 minutes.
- Who can participate: Newborns from birth to 28 days old can participate. Parents or legal guardians must give consent. Babies who have had more than 5% of their total blood volume collected in the past day or are already in the study cannot join.
- Study details: Participants will have blood collected using a heel-stick, which may be done up to two times if necessary. The study will compare the performance of tests on investigational cartridges with an FDA-approved device.
