Evidence map›Paper›PMID 30738243›Full record

ArticleJournal of pharmaceutical and biomedical analysis2019

Development and validation of an assay for quantifying budesonide in dried blood spots collected from extremely low gestational age neonates.

Joseph E Rower, David J Anderson, Catherine M Sherwin, Christopher A Reilly, Philip L Ballard, Cindy T McEvoy, Diana G Wilkins

Open access · greenAbstract read
In one paragraph

Article in Journal of pharmaceutical and biomedical analysis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
4.4field-weighted citation impact, top 6% 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

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022
    Review
  3. Challenges in conducting paediatric trials with off-patent drugs.Contemporary clinical trials communications · 2021
    Article
  4. Article
  5. Review
  6. Review
  7. 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

7 authors at 3 institutions in 1 country.

Joseph E RowerDivision of Clinical Pharmacology, Department of Pediatrics, School of Medicine, University of Utah, Salt Lake City, UT, United States; Department of Pharmacology and Toxicology, College of Pharmacy, University of Utah, Salt Lake City, UT, United States. Electronic address: Joseph.Rower@hsc.utah.edu.
David J AndersonCenter for Human Toxicology, College of Pharmacy, University of Utah, Salt Lake City, UT, United States.
Catherine M SherwinDivision of Clinical Pharmacology, Department of Pediatrics, School of Medicine, University of Utah, Salt Lake City, UT, United States; Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, United States.
Christopher A ReillyDepartment of Pharmacology and Toxicology, College of Pharmacy, University of Utah, Salt Lake City, UT, United States; Center for Human Toxicology, College of Pharmacy, University of Utah, Salt Lake City, UT, United States.
Philip L BallardDepartment of Pediatrics, School of Medicine, University of California, San Francisco, San Francisco, CA, United States.
Cindy T McEvoyDivision of Neonatology, School of Medicine, Oregon Health & Science University, Portland, OR, United States.
Diana G WilkinsCenter for Human Toxicology, College of Pharmacy, University of Utah, Salt Lake City, UT, United States; Department of Pathology, School of Medicine, University of Utah, Salt Lake City, Utah, United States.
University of Utah · USOregon Health & Science University · USUniversity of California, San Francisco · US

Funding

Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
University of Utah Center for Clinical and Translational ScienceUL1TR001067 · NCATS · UNIVERSITY OF UTAH · PI DERE, WILLARD H., HESS, RACHEL · 2013 to 2017
$19.8M
Maternal vitamin C supplementation to decrease effects of smoking during pregnancy on infant lung function and health:Follow-up of 2 randomized trials and association with changes in DNA methylationUG3OD023288 · OD · OREGON HEALTH & SCIENCE UNIVERSITY · PI MCEVOY, CYNTHIA T, SPINDEL, ELIOT R · 2016 to 2024
$4.7M
NCATS NIH HHS UL1 TR001067NCATS NIH HHS UL1 TR002538
6 · The paper itself

Abstract

Budesonide is a potential therapeutic option for the prevention of bronchopulmonary dysplasia in mechanically ventilated premature neonates. The dose and concentrations of budesonide that drive effective prophylaxis are unknown, due in part to the difficulty in obtaining serial blood samples from this fragile population. Of primary concern is the limited total blood volume available for collection for the purposes of a pharmacokinetic study. Dried blood spots (DBS), which require the collection of <200 μL whole blood to fill an entire card, are an attractive low-blood volume alternative to traditional venipuncture sampling. We describe a simple and sensitive method for determining budesonide concentrations in DBS using an ultra-high-performance liquid chromatography - tandem mass spectrometry assay. Budesonide was liberated from a single 6 mm punch using a basified methyl tert-butyl ether extraction procedure. The assay was determined to be accurate and precise in the dynamic range of 1 to 50 ng/mL. The validated assay was then successfully applied to DBS collected as part of a multi-center, dose-escalation study of budesonide administered in surfactant via intra-tracheal instillation to premature neonates between 23 and 28 weeks gestational age. These findings show that DBS are a useful technique for collecting pharmacokinetic samples in premature neonates and other pediatric populations.

Indexed as

Biological AssayBronchopulmonary DysplasiaBudesonideCalibrationChromatography, High Pressure LiquidDried Blood Spot TestingDrug MonitoringGestational AgeHumansInfant, Extremely PrematureInfant, NewbornLimit of DetectionReference StandardsReproducibility of ResultsTandem Mass SpectrometryBudesonideBudesonideDried blood spotsPremature neonatesUHPLC-MS/MS

Identifiers

PMID30738243
PMCPMC7233423
OpenAlexW2913600908

What OpenQuestion holds

Textmetadata
LicenceTDM
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.