Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS

Launched by HOSPICES CIVILS DE LYON · Sep 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying new tests called biomarkers to help doctors better diagnose a serious condition known as late-onset neonatal sepsis (LOS) in newborns. LOS can happen in babies who are at least 7 days old and shows up in Neonatal Intensive Care Units (NICUs). The goal is to find out if these biomarkers can accurately identify babies who do not have an infection, which could help reduce the unnecessary use of antibiotics. Using too many antibiotics can lead to problems like antibiotic resistance and other health issues for babies.

To be eligible for this trial, babies must be hospitalized in the NICU, be at least 7 days old, weigh more than 500 grams, and show certain signs that may suggest an infection, such as fever or difficulty breathing. Participants will have their blood tested and monitored, and their information will help researchers learn more about these biomarkers. It's important to know that babies who are already on antibiotics for a confirmed infection or have had recent surgeries will not be included in this study. This trial aims to improve how infections in newborns are diagnosed and treated, ultimately helping to keep them healthier.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient hospitalized in the NICU of one of the two recruiting centers at the time of inclusion
• • Patients aged ≥ 7 days
• • Patients weighted ≥ 500 g the day of blood sample
• • patients with suggestive signs of LOS including at least one of the following:Fever \> 38°C; tachycardia \> 160bpm; capillary refill time \> 3 seconds; grey and/or pale skin complexion; apnea/ bradycardia syndrome, bloating; vomiting; 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; or any other condition for which the clinician suspected an infection
• • patients with a standard of care blood sampling, including at least a blood culture;
• Exclusion Criteria:
• • Patient treated with antibiotics for a bacteriologically confirmed infection at the time of sampling or within 48 hours prior to sampling
• • Patient who underwent surgery within the previous 7 days
• • Patients vaccinated within the previous 7 days
• • Patient who received treatment with systemic corticosteroid therapy in the 48 hours prior to sampling
• • Patient with severe combined immunodeficiency
• • Opposition from parent(s)/guardian(s)