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Children
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Neonatal Clinical Pharmacology
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Neonatal Clinical Pharmacology

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

Deadline for manuscript submissions: closed (1 April 2024) | Viewed by 9042

Special Issue Editors

Prof. Dr. Karel Allegaert

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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

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Further information on MDPI's Special Issue polices can be found here.

Published Papers (6 papers)

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Editorial

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3 pages, 136 KiB  
Editorial
Neonatal Clinical Pharmacology
by Karel Allegaert, Nadir Yalcin, Robert B. Flint and Sinno H. P. Simons
Children 2024, 11(9), 1102; https://doi.org/10.3390/children11091102 - 9 Sep 2024
Viewed by 258
Abstract
Similar to other populations, care of neonates strongly relies on robust guidance on neonatal pharmacotherapy, covering an age-appropriate drug formulation, an individualized dose, and information on its efficacy and safety for a specific indication in this population, preferably weighted to alternative approaches [...] [...] Read more.
Similar to other populations, care of neonates strongly relies on robust guidance on neonatal pharmacotherapy, covering an age-appropriate drug formulation, an individualized dose, and information on its efficacy and safety for a specific indication in this population, preferably weighted to alternative approaches [...] Full article
(This article belongs to the Special Issue Neonatal Clinical Pharmacology)

Research

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15 pages, 1424 KiB  
Article
Confirming the Suitability of a Gentamicin Dosing Strategy in Neonates Using the Population Pharmacokinetic Approach with Truncated Sampling Duration
by Bonifasius Siyuka Singu, Roger Karel Verbeeck, Clarissa Hildegard Pieper and Ene I. Ette
Children 2024, 11(8), 898; https://doi.org/10.3390/children11080898 - 26 Jul 2024
Viewed by 568
Abstract
(1) Background: Gentamicin is known to be nephrotoxic and ototoxic. Although gentamicin dosage guidelines have been established for preterm and term neonates, reports do show attainment of recommended peak concentrations but toxic gentamicin concentrations are common in this age group. (2) Methods: This [...] Read more.
(1) Background: Gentamicin is known to be nephrotoxic and ototoxic. Although gentamicin dosage guidelines have been established for preterm and term neonates, reports do show attainment of recommended peak concentrations but toxic gentamicin concentrations are common in this age group. (2) Methods: This was a prospective, observational study conducted in Namibia with 52 neonates. A dose of 5 mg/kg gentamicin was administered over 3–5 s every 24 h in combination with benzylpenicillin 100,000 IU/kg/12 h or ampicillin 50 mg/kg/8 h. Two blood samples were collected from each participant using a truncated pharmacokinetic sampling schedule. (3) Results: The one-compartment linear pharmacokinetic model best described the data. Birthweight, postnatal age, and white blood cell count were predictive of clearance (CL), while birthweight was predictive of volume (V). For the typical neonate (median weight 1.57 kg, median postnatal age 4 days (0.011 years), median log-transformed WBC of 2.39), predicted CL and V were 0.069 L/h and 0.417 L, respectively—similar to literature values. Simulated gentamicin concentrations varied with respect to postnatal age and bodyweight. (4) Conclusions: A 5 mg/kg/24 h dosage regimen yielded simulated gentamicin concentrations with respect to age and birthweight similar to those previously reported in the literature to be safe and efficacious, confirming its appropriateness. Full article
(This article belongs to the Special Issue Neonatal Clinical Pharmacology)
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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 - 8 Oct 2023
Cited by 1 | Viewed by 1301
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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Review

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36 pages, 1026 KiB  
Review
An Update on Pharmacologic Management of Neonatal Hypotension: When, Why, and Which Medication
by Eleni Agakidou, Ilias Chatziioannidis, Angeliki Kontou, Theodora Stathopoulou, William Chotas and Kosmas Sarafidis
Children 2024, 11(4), 490; https://doi.org/10.3390/children11040490 - 19 Apr 2024
Viewed by 3773
Abstract
Anti-hypotensive treatment, which includes dopamine, dobutamine, epinephrine, norepinephrine, milrinone, vasopressin, terlipressin, levosimendan, and glucocorticoids, is a long-established intervention in neonates with arterial hypotension (AH). However, there are still gaps in knowledge and issues that need clarification. The main questions and challenges that neonatologists [...] Read more.
Anti-hypotensive treatment, which includes dopamine, dobutamine, epinephrine, norepinephrine, milrinone, vasopressin, terlipressin, levosimendan, and glucocorticoids, is a long-established intervention in neonates with arterial hypotension (AH). However, there are still gaps in knowledge and issues that need clarification. The main questions and challenges that neonatologists face relate to the reference ranges of arterial blood pressure in presumably healthy neonates in relation to gestational and postnatal age; the arterial blood pressure level that potentially affects perfusion of critical organs; the incorporation of targeted echocardiography and near-infrared spectroscopy for assessing heart function and cerebral perfusion in clinical practice; the indication, timing, and choice of medication for each individual patient; the limited randomized clinical trials in neonates with sometimes conflicting results; and the sparse data regarding the potential effect of early hypotension or anti-hypotensive medications on long-term neurodevelopment. In this review, after a short review of AH definitions used in neonates and existing data on pathophysiology of AH, we discuss currently available data on pharmacokinetic and hemodynamic effects, as well as the effectiveness and safety of anti-hypotensive medications in neonates. In addition, data on the comparisons between anti-hypotensive medications and current suggestions for the main indications of each medication are discussed. 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 on behalf of the Neonatal Drug Formularies Group
Children 2023, 10(11), 1803; https://doi.org/10.3390/children10111803 - 13 Nov 2023
Cited by 1 | Viewed by 838
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
Cited by 1 | Viewed by 739
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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