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Children
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Neonatal Clinical Pharmacology
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Special Issue "Neonatal Clinical Pharmacology"

A special issue of Children (ISSN 2227-9067). This special issue belongs to the section "Pediatric Neonatology".

Deadline for manuscript submissions: 1 April 2024 | Viewed by 5831

Special Issue Editors

Prof. Dr. Karel Allegaert

E-Mail Website
Guest Editor
1. Department of Development and Regeneration, KU Leuven, Leuven, Belgium
2. Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
3. Department of Clinical Pharmacy, Erasmus Medical Center, Rotterdam, The Netherlands
Interests: perinatal pharmacology; neonatal clinical pharmacology; PBPK in special populations; newborn; infant; lactation
Special Issues, Collections and Topics in MDPI journals
Dr. Nadir Yalcin
E-Mail Website
Guest Editor
Department of Clinical Pharmacy, Faculty of Pharmacy, Hacettepe University, Ankara, Turkey
Interests: health sciences; pharmacology and therapeutics
Dr. Robert B. Flint

E-Mail Website
Guest Editor
Department of Pediatrics, Division of Neonatology Erasmus University Medical Center – Sophia Children's Hospital, Rotterdam, The Netherlands
Interests: neonatology; obstetrics; perinatal pharmacology; pharmacokinetics; pharmacodynamics; personalized ICT applications
Dr. Sinno H.P. Simons

E-Mail Website
Guest Editor
Department of Pediatrics, Division Neonatology, Erasmus Medical Center, Erasmus MC, University Medical Center-Sophia Children’s Hospital, Research Neonatology (Sk-4246), PO Box 2060, 300 CB, Rotterdam, The Netherlands
Interests: pharmacology; pain and stress; placental pharmacology; sepsis treatment; neonatal apnea; neonatology neonatal pharmacology; perinatal pharmacology

Special Issue Information

Dear Colleagues,

Pharmacotherapy is a very powerful intervention to improve outcome, and this is also true in neonates. The prescription of a given drug should result in a safe and effective intervention to treat or prevent a specific disease or risk in an individual patient or population while avoiding disproportional side-effects. Clinical pharmacology supports these aims in predicting drug-related (side)-effects driven by pharmacokinetics (PK) and pharmacodynamics (PD). The dynamic changes related to maturation and growth in newborns result in a unique setting with extensive variability. Non-maturational changes (such as disease characteristics, drug–drug interactions, pharmacogenetics, and lactation-related exposure) further add to this variability.

This is a growing and active field of clinical research, with several reports on PK, PD, pharmacovigilance and -safety, and pharmaco-epidemiology having been published. This clinical field is further supported by novelties in the methods that are currently available (low-volume sample analysis, population PK analysis, physiology-based PK).

Prof. Dr. Karel Allegaert
Dr. Nadir Yalcin
Dr. Robert B. Flint
Dr. Sinno H.P. Simons
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Children is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2400 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • newborn
  • infant
  • clinical pharmacology
  • clinical pharmacy
  • pharmacokinetics
  • pharmacodynamics
  • pharmacoepidemiology
  • pharmacovigilance
  • drug safety
  • drug
  • lactation

Published Papers (5 papers)

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Research

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13 pages, 1177 KiB  
Article
Strong Association between Inotrope Administration and Intraventricular Hemorrhage, Gestational Age, and the Use of Fentanyl in Very Low Gestational Age Infants: A Retrospective Study
by
Theodora Stathopoulou
,
Eleni Agakidou
,
Christos Paschaloudis
,
Angeliki Kontou
,
Ilias Chatzioannidis
and
Kosmas Sarafidis
Children 2023, 10(10), 1667; https://doi.org/10.3390/children10101667 - 08 Oct 2023
Viewed by 575
Abstract
This was a single center, retrospective cohort study designed to evaluate the association between the administration of inotropes to hypotensive very low gestational age infants (VLGAI) and prenatal and neonatal risk factors. Inpatient medical records were reviewed to identify neonates treated with inotropes [...] Read more.
This was a single center, retrospective cohort study designed to evaluate the association between the administration of inotropes to hypotensive very low gestational age infants (VLGAI) and prenatal and neonatal risk factors. Inpatient medical records were reviewed to identify neonates treated with inotropes (treated group) and a control group for comparison. Two hundred and twenty two (222) VLGAI (less than 32 weeks’ gestation) were included in the final analysis and were stratified based on timing of treatment with 83 infants (37.4%) and 139 infants (62.6%) in the treated and control groups, respectively. A total of 56/83 (67%) received inotropes for arterial hypotension during the first 3 days (early treatment subgroup) and 27/83 (32.5%) after 3 days of life (late-treated subgroup). Fentanyl, severe intraventricular hemorrhage (IVH), and gestational age (GA) were the risk factors most significantly associated with the need for inotrope use both during the first 3 days of life and the whole NICU stay, before and after adjustment for confounders. In conclusion, fentanyl, severe IVH, and GA are the risk factors most strongly associated with the need for inotrope treatment in VLGAI. Measures to modify these risk factors may decrease the need for cardiovascular medications and improve outcomes. Full article
(This article belongs to the Special Issue Neonatal Clinical Pharmacology)
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23 pages, 716 KiB  
Article
Neonatal Drug Formularies—A Global Scope
by
Dotan Shaniv
,
Srinivas Bolisetty
,
Thomas E. Young
,
Barry Mangum
,
Sean Ainsworth
,
Linda Elbers
,
Petra Schultz
,
Melanie Cucchi
,
Saskia N. de Wildt
,
Tjitske M. van der Zanden
,
Neil Caldwell
,
Anne Smits
and
Karel Allegaert
Children 2023, 10(5), 848; https://doi.org/10.3390/children10050848 - 08 May 2023
Cited by 3 | Viewed by 2193
Abstract
Neonatal drug information (DI) is essential for safe and effective pharmacotherapy in (pre)term neonates. Such information is usually absent from drug labels, making formularies a crucial part of the neonatal clinician’s toolbox. Several formularies exist worldwide, but they have never been fully mapped [...] Read more.
Neonatal drug information (DI) is essential for safe and effective pharmacotherapy in (pre)term neonates. Such information is usually absent from drug labels, making formularies a crucial part of the neonatal clinician’s toolbox. Several formularies exist worldwide, but they have never been fully mapped or compared for content, structure and workflow. The objective of this review was to identify neonatal formularies, explore (dis)similarities, and raise awareness of their existence. Neonatal formularies were identified through self-acquaintance, experts and structured search. A questionnaire was sent to all identified formularies to provide details on formulary function. An original extraction tool was employed to collect DI from the formularies on the 10 most commonly used drugs in pre(term) neonates. Eight different neonatal formularies were identified worldwide (Europe, USA, Australia-New Zealand, Middle East). Six responded to the questionnaire and were compared for structure and content. Each formulary has its own workflow, monograph template and style, and update routine. Focus on certain aspects of DI also varies, as well as the type of initiative and funding. Clinicians should be aware of the various formularies available and their differences in characteristics and content to use them properly for the benefit of their patients. Full article
(This article belongs to the Special Issue Neonatal Clinical Pharmacology)
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10 pages, 633 KiB  
Article
An Artificial Intelligence Approach to Support Detection of Neonatal Adverse Drug Reactions Based on Severity and Probability Scores: A New Risk Score as Web-Tool
by
Nadir Yalçın
,
Merve Kaşıkcı
,
Hasan Tolga Çelik
,
Karel Allegaert
,
Kutay Demirkan
,
Şule Yiğit
and
Murat Yurdakök
Children 2022, 9(12), 1826; https://doi.org/10.3390/children9121826 - 26 Nov 2022
Cited by 1 | Viewed by 1552
Abstract
Background: Critically ill neonates are at greater risk for adverse drug reactions (ADRs). The differentiation of ADRs from reactions associated with organ dysfunction/immaturity or genetic variability is difficult. Methods: In this prospective cohort study, each ADR was assessed using newborn-specific severity and probability [...] Read more.
Background: Critically ill neonates are at greater risk for adverse drug reactions (ADRs). The differentiation of ADRs from reactions associated with organ dysfunction/immaturity or genetic variability is difficult. Methods: In this prospective cohort study, each ADR was assessed using newborn-specific severity and probability scales by the clinical pharmacist. Subsequently, a machine learning-based risk score was designed to predict ADR presence in neonates. Results: In 98/412 (23.8%) of (56.3%; male) neonates included, 187 ADRs (0.42 ADR/patient) were determined related to 49 different drugs (37.12%). Drugs identified as high risk were enoxaparin, dexmedetomidine, vinblastine, dornase alfa, etoposide/carboplatin and prednisolone. The independent variables included in the risk score to predict ADR presence, according to the random forest importance criterion, were: systemic hormones (2 points), cardiovascular drugs (3 points), diseases of the circulatory system (1 point), nervous system drugs (1 point), and parenteral nutrition treatment (1 point), (cut-off value: 3 points). This risk score correctly classified 91.1% of the observations in the test set (c-index: 0.914). Conclusions: Using the high-performing risk score specific to neonates, it is expected that high-risk neonatal ADRs can be determined and prevented before they occur. Moreover, the awareness of clinicians of these drugs can be improved with this web-tool, and mitigation strategies (change of drug, dose, treatment duration, etc.) can be considered, based on a benefit-harm relationship for suspected drugs with a newborn-centered approach. Full article
(This article belongs to the Special Issue Neonatal Clinical Pharmacology)
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3 pages, 178 KiB  
Reply
A Callout for International Collaboration. Reply to Giger, E.V.; Tilen, R. Comment on “Shaniv et al. Neonatal Drug Formularies—A Global Scope. Children 2023, 10, 848”
by
Dotan Shaniv
,
Anne Smits
,
Karel Allegaert
and
Children 2023, 10(11), 1803; https://doi.org/10.3390/children10111803 - 13 Nov 2023
Viewed by 275
Abstract
We are very grateful that the global-scope paper on neonatal drug formularies has received a relevant amount of interest from the readership of the journal [...] Full article
(This article belongs to the Special Issue Neonatal Clinical Pharmacology)
2 pages, 155 KiB  
Comment
Comment on Shaniv et al. Neonatal Drug Formularies—A Global Scope. Children 2023, 10, 848
by
Elisabeth V. Giger
and
Romy Tilen
Children 2023, 10(11), 1802; https://doi.org/10.3390/children10111802 - 13 Nov 2023
Viewed by 230
Abstract
We read the article by Shaniv D. et al. entitled “Neonatal Drug Formularies—A Global Scope” [...] Full article
(This article belongs to the Special Issue Neonatal Clinical Pharmacology)
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