Clinical Trials Logo
  1. Home
  2. Late-Onset Neonatal Sepsis
  3. NCT03299751

Evaluation of bioMarkErs to Reduce Antibiotics Use in hospitalizeD nEonates — EMERAUDE  

Late-Onset Neonatal Sepsis Clinical Trial

Official title:
Evaluation of Biomarkers Combination Performance for the Diagnosis of Neonatal Sepsis in NICU Hospitalized Newborns

Clinical Trial Summary

Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments). Despite its high prevalence, a reliable diagnostic remains difficult. Currently, nonspecific clinical signs that might be linked to other neonatal conditions, such as prematurity and birth defects are used to determine the diagnosis of LOS. Laboratory results of biological markers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT) are often delayed in comparison with LOS onset. Blood culture results are too late and lack sensitivity. Excessive antibiotic use is observed in a large proportion of NICU hospitalized newborns. This results in an increased antibiotic resistance, microbiota modification, neonatal complications (pulmonary, ophthalmologic and neurologic) and mortality. The primary objective is to identify, on a cohort of 250 patients, the optimal biomarker combination with good diagnostic performance (i.e. with maximal Area Under the ROC Curve) to early exclude a LOS diagnostic in newborns of at least 7 days of life with suggestive signs. This identification will be carried out, as a secondary objective, with a sub-group of pre-term neonates whose birth weight is less than 1500 grams. The diagnostic value of the clinical signs that are suggestive of LOS will also be determined (sensitivity, specificity, negative and positive predictive values). Once identified, the biomarker combination is expected to reduce unjustified antibiotic use.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03299751
Study type Interventional
Source Hospices Civils de Lyon
Contact
Status Completed
Phase N/A
Start date November 22, 2017
Completion date November 20, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05530330 - Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants
Not yet recruiting NCT06199102 - The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. N/A
Recruiting NCT04717037 - Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS) Phase 2/Phase 3
Not yet recruiting NCT06118801 - The Effect of Probiotics Added to the Mother's Diet on Preterm Babies N/A
Recruiting NCT04842786 - Topical Coconut Oil Application and Incidence of Sepsis in Neonates N/A
Completed NCT03822104 - Bovine Colostrum as a Human Milk Fortifier for Preterm Infants N/A
Completed NCT04424667 - Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants N/A
Recruiting NCT05981079 - Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis. Phase 4
Recruiting NCT05991648 - Effect of Kangaroo Care on Heart Rate Variability in Late-onset Neonatal Sepsis N/A
Completed NCT03085277 - Bovine Colostrum for Preterm Newborns N/A
Recruiting NCT05347238 - Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Completed NCT04792918 - Characterization of Intestinal Microbiota Stability in Preterm Born Neonates
Recruiting NCT03997266 - NICU Antibiotics and Outcomes Trial Phase 4
Completed NCT03633500 - Effectiveness of Oral Immunotherapy Among Preterm Babies N/A