Reference Range and Clinical Performance Evaluation of Elecsys IL-6 Assay in Neonatal Sepsis
G
Gregory Sokol, MD
Primary Investigator
Administratively Closed
All
Phase
N/A
15 participants needed
2 Locations
Brief description of study
This study aims to evaluate how well the IL-6 assay works to detect sepsis in infants.
Detailed description of study
Parents will provide consent. Researchers will collect a blood sample from the newborn. If possible, remnant blood from relevant clinical tests will be used.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: sepsis, Riley
-
Gender: All
Inclusion Criteria:
- Newborns, term or pre-term, admitted to a neonatal ICU (≤28 days of age)
- Clinical suspicion of infection (blood or CSF culture ordered), sepsis work-up (blood draw for blood culture) done or ordered.
- Signed parental informed consent
- Healthy newborns, < 28 days old
Exclusion Criteria:
- Patient is not eligible for a blood draw for the purpose of this clinical study based on physician/ nurse opinion (e.g. severe anemia, very low birth weight)
- Surgery in the last 5 days
Updated on
24 Mar 2025.
Study ID: 13485, PNEO-ROCHE-ELCSYS-IL-6
