Observational studyPharmaceutical research2015
An observational study of blood concentrations and kinetics of methyl- and propyl-parabens in neonates.
Observational study in Pharmaceutical research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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.
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.
Who cites it
12 citing papers in PubMed, 44 citations in OpenAlex.
- Quantitative Investigation on Exposure to Potentially Harmful Excipients by Injection Drug Administration in Children Under 2 Years of Age and Analysis of Association with Adverse Events: A Single-Center, Retrospective Observational Study.Therapeutic innovation & regulatory science · 2024Observational
- A state-of-the-science review and guide for measuring environmental exposure biomarkers in dried blood spots.Journal of exposure science & environmental epidemiology · 2023Review
- Endocrine-Disrupting Chemicals and Persistent Organic Pollutants in Infant Formulas and Baby Food: Legislation and Risk Assessments.Foods (Basel, Switzerland) · 2023Review
- Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study-Focus on Formulation in Children.Children (Basel, Switzerland) · 2022Article
- The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region.Children (Basel, Switzerland) · 2022Review
- Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan.Journal of pharmaceutical health care and sciences · 2021Article
- Presence of Bisphenol A and Parabens in a Neonatal Intensive Care Unit: An Exploratory Study of Potential Sources of Exposure.Environmental health perspectives · 2019Article
- Assessing the antiandrogenic properties of propyl paraben using the Hershberger bioassay.Toxicology research · 2018Article
- Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients.International journal of pharmaceutics · 2018Article
- Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered.Pharmaceutical medicine · 2018Article
- Product Substitution as a Way Forward in Avoiding Potentially Harmful Excipients in Neonates.Paediatric drugs · 2016Article
- Neonatal drug therapy: The first frontier of therapeutics for children.Clinical pharmacology and therapeutics · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 7 institutions in 2 countries.
Funding
Abstract
purposeSystemic exposure to parabens in the neonatal population, in particular propyl-parabens (PPB), remains a concern. Blood concentrations and kinetics of methyl-parabens (MPB) and PPB were therefore determined in neonates receiving medicines containing these excipients.
methodsA multi-centre, non-interventional, observational study of excipient-kinetics in neonates. 'Dried Blood Spot' samples were collected opportunistically at the same time as routine samples and the observations modelled using a non-linear mixed effects approach.
resultsA total of 841 blood MPB and PPB concentration data were available for evaluation from 181 pre- and term-neonates. Quantifiable blood concentrations of MPB and PPB were observed in 99% and 49% of patients, and 55% and 25% of all concentrations were above limit of detection (10 ng/ml), respectively. Only MPB data was amenable to modelling. Oral bioavailability was influenced by type of formulation and disposition was best described by a two compartment model with clearance (CL) influenced by post natal age (PNA); CL PNA<21 days 0.57 versus CL PNA>21 days 0.88 L/h.
conclusionsDaily repeated administration of parabens containing medicines can result in prolonged systemic exposure to the parent compound in neonates. Animal toxicology studies of PPB that specifically address the neonatal period are required before a permitted daily exposure for this age group can be established.
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What OpenQuestion holds
Registered trials
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.