Evidence map›Paper›PMID 30281170›Full record

Trial reportBritish journal of clinical pharmacology2019

Effects of maturation and size on population pharmacokinetics of pentoxifylline and its metabolites in very preterm infants with suspected late-onset sepsis or necrotizing enterocolitis: a pilot study incorporating clinical outcomes.

Sam Salman, Julie Hibbert, Madhu Page-Sharp, Laurens Manning, Karen Simmer, Dorota A Doherty, Sanjay Patole, Kevin T Batty, Tobias Strunk

Open access · bronzeAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.4field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
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  11. A Neonatal MurineFrontiers in immunology · 2020
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Sam SalmanMedical School, University of Western Australia, Crawley, WA, Australia.ORCID 0000-0002-8276-6784
Julie HibbertCentre for Neonatal Research and Education, School of Medicine, University of Western Australia, Crawley, WA, Australia.
Madhu Page-SharpSchool of Pharmacy and Biomedical Sciences, Curtin University, Bentley, WA, Australia.
Laurens ManningMedical School, University of Western Australia, Crawley, WA, Australia.
Karen SimmerCentre for Neonatal Research and Education, School of Medicine, University of Western Australia, Crawley, WA, Australia.
Dorota A DohertyDivision of Obstetrics and Gynaecology, University of Western Australia, Crawley, WA, Australia.
Sanjay PatoleCentre for Neonatal Research and Education, School of Medicine, University of Western Australia, Crawley, WA, Australia.
Kevin T BattySchool of Pharmacy and Biomedical Sciences, Curtin University, Bentley, WA, Australia.
Tobias StrunkCentre for Neonatal Research and Education, School of Medicine, University of Western Australia, Crawley, WA, Australia.
The University of Western Australia · AUCurtin University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsInfection-induced inflammation is associated with adverse long-term outcomes in preterm infants. Pentoxifylline (PTX) is a candidate for adjunct immunomodulatory therapy in preterm infants with late-onset sepsis (LOS) and necrotizing enterocolitis (NEC), but pharmacokinetic data in this population are extremely limited. This study aims to characterize the pharmacokinetic properties of intravenous PTX and its metabolites in preterm infants.

methodAn open label pilot clinical study of intravenous PTX as an adjunct therapy in preterm infants (gestation <32 weeks) with suspected LOS or NEC was undertaken. PTX was infused for 12 h for two days (60 mg kg

resultsThe preterm infants (n = 26) had a median (range) gestation of 24.8 weeks (23.3-30.4) and birthweight of 689 g (370-1285). PTX was well tolerated and without treatment-limiting adverse effects. Changes in size (weight) and maturation were successfully modelled for PTX and metabolites. After allometric scaling, clearance increased with postmenstrual age, increasing by approximately 30% per week for PTX and M1 (lisofylline) and simulations of current dosing demonstrated a six-fold difference in exposure between 24 and 35 weeks postmenstrual age.

conclusionsThe developed model can be used to explore dosing strategies based on size and maturation for preterm infants.

Indexed as

Administration, IntravenousBody WeightDrug Therapy, CombinationEnterocolitis, NecrotizingFemaleHumansInfantInfant, Extremely PrematureInfant, NewbornInfant, Premature, DiseasesInfant, Very Low Birth WeightMaleMetabolic Clearance RateModels, BiologicalPentoxifyllinePhosphodiesterase InhibitorsPentoxifyllinePhosphodiesterase Inhibitorslate-onset sepsislisofyllinenecrotizing enterocolitispentoxifyllinepopulation pharmacokineticspreterm infant

Identifiers

PMID30281170
PMCPMC6303212
OpenAlexW2894786698

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.