Pentoxifylline Dose Optimization in Neonatal Sepsis
Neonatal Late Onset Sepsis
About this trial
This is an interventional treatment trial for Neonatal Late Onset Sepsis focused on measuring Pentoxifylline, preterm infants, sepsis treatment, dose optimization
Eligibility Criteria
Inclusion Criteria:
- Preterm born neonates with gestational age <30 weeks
- Suspected of late onset sepsis with blood drawn for blood culture and inflammatory biomarkers
- IL-6 > 500 pg/mL and/or CRP > 50 mg/L
Exclusion Criteria:
- pentoxifylline therapy cannot be started within 24 hours of start of antibiotic treatment.
- Major congenital defect (e.g. congenital heart disease, pulmonary, or gastrointestinal anomalies).
- IL-6 values exceeding 25000 pg/mL at time of onset. High IL-6 values represent severe episodes of sepsis and high IL-6 values are associated with high mortality rates.
- 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 start of sepsis episode.
Sites / Locations
- Erasmus MC Sophia Children's HospitalRecruiting
- University Hospital PoznanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Pentoxifylline therapy 2,5 mg/kg/h for 3 hours.
Pentoxifylline therapy 2,5 mg/kg/h for 6 hours
Pentoxifylline therapy 5 mg/kg/h for 6 hours.
Pentoxifylline therapy 5 mg/kg/h for 12 hours.
Pentoxifylline therapy 5 mg/kg/h for 18 hours.
Pentoxifylline therapy 5 mg/kg/h for 24 hours.
This is a dose optimization study, different dosages will be tested, the lowest dosage that will be tested is 2,5 mg/kg/h for 3 hours every 24 hours for 3 to 6 days. The decision to prolong therapy after 3 days of therapy is made by the treating physician, depending on the clinical state of the patient and the severity of disease.
The second lowest dosage that will be tested is 2,5 mg/kg/h for 6 hours every 24 hours for 3 to 6 days. The decision to prolong therapy after 3 days of therapy is made by the treating physician, depending on the clinical state of the patient and the severity of disease.
The third lowest dosage, is the start dosage and the dosage that is already used in other clinical studies: 5 mg/kg/h for 6 hours every 24 hours for 3 to 6 days. The decision to prolong therapy after 3 days of therapy is made by the treating physician, depending on the clinical state of the patient and the severity of disease.
The fourth dosage that is tested is 5 mg/kg/h for 12 hours every 24 hours for 3 to 6 days. The decision to prolong therapy after 3 days of therapy is made by the treating physician, depending on the clinical state of the patient and the severity of disease..
The fifth dosage that is tested is 5 mg/kg/h for 18 hours every 24 hours for 3 to 6 days. The decision to prolong therapy after 3 days of therapy is made by the treating physician, depending on the clinical state of the patient and the severity of disease.
The sixth dosage that is tested is 5 mg/kg/h for 24 hours every 24 hours for 3 to 6 days. The decision to prolong therapy after 3 days of therapy is made by the treating physician, depending on the clinical state of the patient and the severity of disease.