Evaluation of bioMarkErs to Reduce Antibiotics Use in hospitalizeD nEonates (EMERAUDE)
Late-Onset Neonatal Sepsis
About this trial
This is an interventional diagnostic trial for Late-Onset Neonatal Sepsis focused on measuring neonatal sepsis, biomarker combination, diagnostic, antibiotic use, newborn, preterm neonates, NICU
Eligibility Criteria
Inclusion Criteria:
- patients hospitalized in NICU;
patients with suggestive signs of LOS including at least one of the following:
o Fever > 38°C; tachycardia > 160bpm160 bpm; capillary refill time > 3 seconds; grey and/or pale skin complexion; apnea/ bradycardia syndrome,; bloating; rectal bleeding; hypotonia; lethargy; seizures without other obvious cause; increased ventilatory support and/or increased FiO2; cutaneous rash; inflammation at the needle-puncture site of the central venous catheter;
- patients with a standard of care blood sampling, including at least a blood culture;
- consent form signed by at least one parent/ legal representative.
Exclusion Criteria:
- patients treated with antibiotics for a bacteriologically confirmed infection at the moment of/ or 48 hours before blood sampling
- patients who underwent surgery during the 7 days prior to inclusion
- patients vaccinated during the 7 days prior to inclusion
Sites / Locations
- Hospices Civils de Lyon
- CHU de Nantes
Arms of the Study
Arm 1
Experimental
NICU newborns of at least 7 days of life with suggestive signs