A Novel Maturation Equation for Hepatic Clearance Across Preterm, Term Neonates, Children, and Adults: Application to Paracetamol and Its Metabolite.

A preterm and term neonate to adult (PTNA) maturation equation was introduced recently to describe the glomerular filtration rate maturation from birth to adulthood for neonates of varying gestational age. This study aims to evaluate the newly developed PTNA equation against common maturation approaches like allometric scaling (AS0.75), the AS0.

Leveraging Deep Learning to Enhance Malnutrition Detection via Nutrition Risk Screening 2002: Insights from a National Cohort.

This study aimed to develop and validate a new machine learning (ML)-based screening tool for a two-step prediction of the need for and type of nutritional therapy (enteral, parenteral, or combined) using Nutrition Risk Screening 2002 (NRS-2002) and other demographic parameters from the Optimal Nutrition Care for All (ONCA) national cohort data. This multicenter retrospective cohort study included 191,028 patients, with data on age, gender, body mass index (BMI), NRS-2002 score, presence of cancer, and hospital unit type. In the first step, classification models estimated whether patients required nutritional therapy, while the second step predicted the type of therapy.

Pragmatic and contextualized methods selection for safety assessment of infant systemic exposure through human milk: the Milk4baby decision tree approach - a contribution from the concePTION project.

More than 50% of women take at least one medication during lactation. However, 54% of drugs in the LactMed database lack lactation safety data, and only 2% have robust evidence. This highlights a significant gap in guidance for designing pharmacokinetic and safety studies characterizing infant safety following medication exposure during lactation, despite FDA guidelines recommending clinical lactation studies.

Is noxious stimulus-evoked electroencephalography response a reliable, valid, and interpretable outcome measure to assess analgesic efficacy in neonates? A systematic review and individual participant data (IPD) meta-analysis protocol.

Background: There are several major challenges limiting our ability to test analgesic efficacy for treatment of neonatal pain, and progress in analgesic drug studies in neonates has stalled. One significant issue is the reliance of clinical pain assessments on traditional behavioural and vital signs-based measures and the exclusion of novel brain-based biomarkers. In this review protocol, we outline our strategy to assess the reliability, validity, and interpretability of an electroencephalography (EEG)-based response biomarker for assessment of acute somatic nociceptive pain in neonates.

Ventricular-arterial coupling is preserved in prematurely born 11-year-old children but calls for life-long prevention of hemodynamic deterioration.

Background: Premature birth disrupts the intra-uterine structural and functional maturation of the left ventricle (LV) and arteries. The study investigated the impact of premature birth on ventricular-arterial coupling (VAC), a potential precursor of cardiovascular disease in adulthood.

Methods: This case-control study in Northern Belgium (2011-2016) included 93 extremely-low-birth-weight (ELBW) cases and 87 sex and age-matched term-born controls.

Predicting Drug Transfer Into Human Milk With the Simcyp Simulator: A Contribution From the ConcePTION Project.

Physiologically-based pharmacokinetic (PBPK) modeling can support decision-making on maternal medication use during breastfeeding. This study aimed to enhance lactation PBPK models in two ways. First, the utility of integrating permeability- versus perfusion-limited distribution to human milk was explored using the Simcyp Simulator.

Caffeine and preterm infants: multiorgan effects and therapeutic creep: scope to optimise dose and timing.

Caffeine is a methylxanthine used for nearly 50 years in the treatment of apnoea of prematurity (AOP). Caffeine citrate is effective in the treatment of AOP using standard dosing (loading dose 20 mg/kg, maintenance 5-10 mg/kg/day) and is associated with long-term neurological benefits and other improved organ outcomes as well as immunomodulatory effects. Therapeutic creep has been noted in the use of caffeine in preterm infants differing from the criteria in randomised controlled trials.

Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions.

: Proton pump inhibitors (PPIs) are widely used for gastric acid suppression, yet their efficacy and safety in neonates and infants remain unclear. While esomeprazole is the only Food and Drug Administration (FDA)-approved PPI for neonates and infants under 1 year of age, other PPIs are also frequently prescribed. : This study utilizes FDA Adverse Event Reporting System (FAERS) data to evaluate potential adverse drug events (ADEs) of PPIs, providing crucial real-world insights into their safety in this vulnerable population.

The Special Issue on Neonatology for the 10th Anniversary of : From Preclinical Findings to Bringing Families to the Centre of Contemporary Neonatal Care.

Neonatology is a specialized branch of medicine, focussed on the care of newborns, either related to preterm birth or other medical conditions like sepsis, asphyxia, or congenital malformations [...

Vancomycin dosing in neonates: enhancing outcomes using population pharmacokinetics and simulation.

Introduction: Optimizing vancomycin dosing in neonates is a critical yet complex goal. Traditional trough concentration-based dosing strategies correlate poorly with therapeutic efficacy and often fail to account for the significant renal function variability and drug clearance in neonates. The 24-hour area under the concentration-time curve to minimum inhibitory concentration (AUC/MIC) ≥ 400 mg h/L has emerged as a superior pharmacodynamic target.

Machine learning based clinical decision tool to predict acute kidney injury and survival in therapeutic hypothermia treated neonates.

Therapeutic hypothermia (TH) significantly reduces mortality and morbidities in neonates with Neonatal Encephalopathy (NE). NE may result in neonatal death and multisystem organ impairment, including acute kidney injury (AKI). Our study aimed to utilize machine learning (ML) methods to predict the outcome of TH-treated NE neonates developing AKI and death during TH.

Pain management in preterm infants with necrotizing enterocolitis: an international expert consensus statement.

Unlabelled: Necrotizing enterocolitis (NEC) is probably the most painful intestinal disease affecting infants born preterm. NEC is known to cause highly severe and prolonged pain that has been associated with adverse short- and long-term effects. However, research on pain management in infants with NEC is scarce.

Maternal Socioeconomic Status and the Initiation and Duration of Breastfeeding in Western Europe Versus Southern Africa: A Systematic Review-A Contribution from the ConcePTION Project.

Breastfeeding is associated with many health benefits, while its prevalence is determined by numerous factors, including socioeconomic status (SES). SES is the position of an individual on the socioeconomic scale, using occupation, education, income, place of residence, and wealth as key indicators. Since its interrelationship with health is complex, world region-specific insights into the relevant socioeconomic inequalities impacting breastfeeding practices are crucial to effectively address these.

Clopidogrel transfer into human milk: case series - a contribution from the ConcePTION project.

Introduction: Implementation of breastfeeding recommendations is hampered by-among others-lacking information regarding medicine safety during breastfeeding. This article describes the clinical and pharmacokinetic data of breastfeeding mothers using clopidogrel (CLP) as secondary prevention following (suspicion of) a cerebrovascular accident.

Methods: A 29-year-old and 42-year-old woman were chronically treated with 75 mg CLP once daily.

Neonatal Kidney Function, Injury and Drug Dosing: A Contemporary Review.

In neonates, estimation of the glomerular filtration rate is problematic, and assessment of renal impairment is challenging. Serum creatinine is a widely used marker, and urine output is an important vital parameter monitored in intensive care settings, particularly in unwell neonates. However, the rapid changes after birth with adaptation to the extrauterine environment is a unique situation in which absolute serum creatinine is not a reliable indicator of renal function.

Sodium Patterns and Their Variables in a Cohort of ELBW Infants in the First 10 Days of Life.

: Sodium regulation is critical in extremely low-birth-weight (ELBW, <1000 g) infants. In a recent systematic review, a sodium pattern over postnatal age and its variables (care factors, fluid regimens, and maturational factors) has been summarized. However, this systematic review also illustrated the shortages and limitations of reported cohorts, and the need to report on additional datasets.

Pharmacokinetics of betamethasone in pre-eclampsia: An in vivo and ex vivo study.

Aims: To enhance understanding of betamethasone and its metabolites' pharmacokinetics in pregnancy, specifically early-onset pre-eclampsia, through a population pharmacokinetic model. Additionally, to investigate the placental metabolism and transfer of betamethasone and its main metabolites.

Methods: A prospective, single-centre pharmacokinetic study was conducted in pregnant women (n = 28) with imminent preterm birth treated with intramuscular betamethasone.

A global cross-sectional survey on neonatal analgosedation: unveiling global trends and challenges through latent class analysis.

Purpose: This study aims to analyze global prescribing patterns for analgosedation in neonates during four critical care scenarios. The research explores existing patterns, their association with geographic and sociodemographic index (SDI), and adherence to evidence-based practices.

Methods: Data from a 2024 global survey of 924 responses to 28 questions were analyzed, focusing on four items for their high variability: premedication in intubation (Q17), sedation in preterm (Q19) and full-term newborns (Q23), and perinatal asphyxia (Q26).

Amikacin dosing in neonates: evaluation of target attainment using a simplified and complex pharmacokinetic model-derived dosing regimen in clinical practice.

Amikacin is frequently used for the treatment of neonatal sepsis. The Dutch Pediatric Formulary recommends a complex pharmacokinetic (PK) model-derived dosing regimen, which consists of dosing categories based on postnatal age and weight that results in adequate PK/pharmacodynamic (PK/PD) target attainment. However, a simplified dosing regimen may be easier to apply in clinical practice.

Hypo- and Hypernatremia in Extremely Low Birth Weight Infants in the First 10 Days of Life: A Review.

Background/objectives: Sodium regulation is critical in extremely low birth weight (ELBW, <1000 g) infants. This study aimed to provide a comprehensive overview of sodium dynamics and related variables in ELBW infants in their first 10 days of life through a structured literature review.

Methods: Applying PRISMA guidelines, six databases were searched (1 August 2023) on sodium measurements in ELBW cohorts, with quality assessment (RoB2, ROBINS-1, Newcastle Ottawa scale) of retained papers, and subsequent data extraction in line with these PRISMA guidelines to describe findings.