Late onset neonatal sepsis
Conditions
Interventions
intravenously administered pentoxifylline
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - Neonates with gestational age 500 pg/mL or CRP >50 mg/L at onset
Exclusion criteria
Exclusion criteria: - PTX therapy cannot be started within 24 hours of start of antibiotic treatment. - Patients with major congenital defects (e.g. congenital heart disease, pulmonary, or gastrointestinal anomalies) will also be excluded. - If subjects have IL-6 values exceeding 25000 pg/mL at time of onset they will also be excluded. High IL-6 values represent severe episodes of sepsis and high IL-6 values are associated with high mortality rates. - Patients who already participated in this trial during an earlier episode of late onset sepsis. - pH below 7 in two consecutive blood samples, with at least 1 hour between the blood samples, at onset of sepsis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the optimal dose of PTX in preterm neonates suffering from late onset sepsis. Dose optimisation will be based on the clinical and biochemical (CRP, IL-6, PCT, TNF-a) response 3 days after start of PTX therapy and on side effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters include the evaluation of longitudinally determined 91 inflammatory markers (Olink proteomics) and metabolomics of the whole inflammatory panel, to further understand the inflammatory and immunological changes of preterm infants during sepsis with PTX treatment and the pharmacokinetics of PTX and its metabolites in preterm infants. A target concentration will be calculated | — |
Contacts
Public ContactSinno Simons
Erasmus MC - Sophia
Outcome results
None listed