ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood
Congenital Heart Disease
About this trial
This is an interventional other trial for Congenital Heart Disease focused on measuring Blood gas
Eligibility Criteria
Inclusion Criteria: The following are the inclusion criteria for the neonatal subjects: The age of the subject must be ≤28 days. Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee. Subjects having a sample drawn as part of standard of care that meets the requirements for samples in this study. The following are the inclusion criteria for the subjects providing placenta for cord blood: • Delivery ≥38 weeks of gestation. Exclusion Criteria: The following are the exclusion criteria for the neonatal subjects: Subject who has already provided successful results from arterial, venous and mixed venous/arterial samples, to cover both syringe modes and the capillary mode and parameters. Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference. Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety). The following are the exclusion criteria for the subjects providing placenta for cord blood: • Subjects positive of HIV or Hepatitis C
Sites / Locations
- St Louis Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Investigational Device
Predicate device
The test device in this clinical study is the ABL90 FLEX PLUS running SW3.5 MR2 manufactured by Radiometer Medical ApS The analyzer provides results for 17 parameters in 35 seconds using 65 µL heparinized whole blood. However, in this investigation only the data concerning the parameters ctBil and FHbF will be evaluated.
The predicate device for this study is the unmodified device ABL90 FLEX PLUS (k160153) running software SW 3.1 MR7 including sensor casettes and solution packs versions corresponding to 2016. ABL90 FLEX PLUS SW 3.1 MR7, has been selected as the predicate device because it has the appropriate 510(k) clearance, and the intended use matches the ABL90 FLEX PLUS SW. SW3.5 MR2 device.