Sepsis is a very important cause of death and morbidity in preterm infants. There are strong indications that preterm neonates with sepsis could benefit, next to antibiotics, from treatment with pentoxifylline (PTX). Knowledge about optimal dosing is however limited. This study is a dose optimization study using a step-up and step-down model. In order to find the optimal dose, the infusion of pentoxifylline in different dosages will be studied, next to antibiotics with 3 patients per dosage. After the dose optimization study an additional cohort of 10 patients will be treated with the found dosage as a validation of the dose.
Who can participate
Age range
30 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was specifically studying neonatal late-onset sepsis — can you help me understand whether my baby's type and timing of sepsis matches what this study was looking at?
2Since this was a Phase 3 trial focused on finding the right dose of pentoxifylline, does that mean the optimal dose has now been identified, and is that information being applied in current treatment decisions for babies like mine?
3Pentoxifylline is not a standard first-line sepsis antibiotic — can you explain what role it would play alongside existing treatments, and whether adding it carries any additional risks for a newborn?
4Now that this trial is completed, are the results published or available, and do those findings change how you would approach treating my baby's sepsis today?
5Are there other completed or ongoing trials, or standard-of-care options, that you think might be a better fit for my baby's situation compared to what was studied in this pentoxifylline trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.