ArticleBMC pediatrics2021
Protocol: Pentoxifylline optimal dose finding trial in preterm neonates with suspected late onset sepsis (PTX-trial).
Article in BMC pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04152980 (Pentoxifylline Dose Optimization in Preterm Neonatal Late Onset Sepsis), which is not on this map. Cited by 7 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pentoxifylline Dose Optimization in Preterm Neonatal Late Onset Sepsis
Who cites it
7 citing papers in PubMed, 12 citations in OpenAlex.
- Targeted proteomics in late-onset neonatal sepsis: an exploratory analysis.Pediatric research · 2026Article
- Pentoxifylline in patients with COVID-19 and with liver cirrhosis or metabolic dysfunction-associated steatotic liver disease: Emerging insights.Biomedical reports · 2026Article
- Early immune modulation in cerebral palsy medical management of cerebral palsy series.Pediatric research · 2025Article
- Role of pentoxifylline in neonatal hypoxic ischaemic encephalopathy: a systematic review of animal studies.Laboratory animal research · 2024Review
- Physicochemical compatibility of pentoxifylline injection with high-concentration parenteral medications.Pediatric investigation · 2023Article
- The neonatal adverse event severity scale: current status, a stakeholders' assessment, and future perspectives.Frontiers in pediatrics · 2023Article
- Introducing heart rate variability monitoring combined with biomarker screening into a level IV NICU: a prospective implementation study.European journal of pediatrics · 2022Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLate onset sepsis is a leading cause of death and morbidity in preterm infants. Despite optimal antibiotic treatment, sepsis related mortality and morbidity is still high. Pentoxifylline (PTX) is a methylxanthine with promising immunomodulatory properties, which can be used as an additional therapy next to antibiotics in preterm infants. PTX is increasingly used off-label in neonatal intensive care units, however up till now no dose finding study has been done for PTX in this specific population. The aim of this study (PTX-trial) is to determine the optimal dose of PTX in preterm infants (gestational age < 30 weeks) with (suspected) late onset sepsis. Dose finding in this particular population is unique, since for most drugs used in neonates the optimal dosage has not been investigated in phase II dose-seeking studies.
methodsThe PTX-trial is a prospective open label sequential dose-optimization study with an adapted continual reassessment method. An up-and-down dose-response design will be used, with dose step-up and step-down titration after every 3 patients. The PTX starting dosage will be 30 mg/kg/day in 6 hours as described in most previous neonatal studies. Efficacy is defined by means of biochemical and clinical parameters. Toxicity in these vulnerable patients is unwarranted. The optimal dose is defined as the ED75 (i.e., clinically and chemically effective dose for 75% of patients) in preterm neonates with late onset sepsis. We plan to include 30 neonates to determine the optimal dose using this study design. Subsequently, the optimal dose will be validated in 10 additional preterm neonates. In parallel, pharmacokinetics of PTX and its metabolites will be described as well as longitudinal evaluation of metabolomics and proteomics. DISCUSSION: The study has been approved by the Regional Medical Ethics Board of Erasmus Medical Center University Rotterdam (MEC 2019-0477) and registered at Clinicaltrials.gov (NCT04152980). Results of the main trial and each of the secondary endpoints will be submitted for publications in peer-reviewed journals.
trial registrationClinicaltrials.gov, NCT04152980 , Registered November 6th, 2019.
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