A5029478749- Neonatal Respiratory Health Research
- Renal Transplantation Outcomes and Treatments
- Pharmaceutical studies and practices
- Drug Transport and Resistance Mechanisms
- Cytomegalovirus and herpesvirus research
- Renal Diseases and Glomerulopathies
- Ethics in Clinical Research
- Infant Development and Preterm Care
- Metabolism and Genetic Disorders
- Neonatal Health and Biochemistry
- Delphi Technique in Research
- Uterine Myomas and Treatments
- Pharmacological Effects and Toxicity Studies
- Cardiac Arrhythmias and Treatments
- Pregnancy-related medical research
- Antimicrobial Resistance in Staphylococcus
- Pain Management and Placebo Effect
- Endometriosis Research and Treatment
- Antibiotics Pharmacokinetics and Efficacy
- Child and Adolescent Health
- Atrial Fibrillation Management and Outcomes
- Herpesvirus Infections and Treatments
- Systemic Lupus Erythematosus Research
- Ethics and Legal Issues in Pediatric Healthcare
- Phytochemistry and Bioactive Compounds
Hôpital Robert-Debré
2009-2023
Assistance Publique – Hôpitaux de Paris
2011-2023
Inserm
2011-2020
PharmacoGenetics (China)
2009-2019
Centre d’Investigation Clinique 1436
2018
Clinical Investigation Center Plurithematic Tours
2014
Université Paris Cité
2011-2014
The aim of this study was to develop a population pharmacokinetic model tacrolimus in pediatric kidney transplant patients, identify factors that explain variability, and determine dosage regimens. Pharmacokinetic samples were collected from 50 de novo patients (age 2–18 years) who on treatment. Population analysis performed using NONMEM, the impact variables (demographic clinical factors, CYP3A4–A5, ABCB1, ABCC2 polymorphisms) tested. data described by two–compartment incorporated...
Background The management of chronic pelvic pain in women with endometriosis is complex and includes the long-term use opioids. Patients not fully responsive to drugs or ineligible for surgical treatments need efficient alternatives improve their quality life avoid sequelae. Objective This randomized controlled trial aimed assess effects repeated at-home administrations a 20-minute virtual reality (VR) solution (Endocare) compared sham condition on experiencing due endometriosis. Methods...
The pharmacokinetics (PK) of fluconazole and micafungin differ in neonates compared with children adults. Dosing instructions product labels appear to be inconsistent the emerging scientific evidence. Limited information is available on safety profile these agents neonates. Our objective was study population PK both drugs, randomly administered suspected or confirmed systemic candidiasis.Neonates were randomized 1:1 (loading dose 25 mg kg-1 ; maintenance 12 day-1 20 , respectively, for...
To develop a population pharmacokinetic model for mycophenolic acid (MPA) in children with idiopathic nephrotic syndrome (INS) treated mycophenolate mofetil (MMF), identify covariates that explain variability and determine the Bayesian estimator of area under concentration-time curve over 12 h (AUC(0-12)).The MMF was described from 23 patients aged 7.4 +/- 3.9 years (range 2.9-14.9) using nonlinear mixed-effects modelling (NONMEM) software. A two-compartment lag-time first-order absorption...
Background Atrial fibrillation affects approximately 4% of the world’s population and is one major causes stroke, heart failure, sudden death, cardiovascular morbidity. It can be difficult to diagnose when asymptomatic or in paroxysmal stage, its natural history not well understood. New wearables connected devices offer an opportunity improve on this situation. Objective We aimed validate algorithm for automatic detection atrial from a single-lead electrocardiogram taken with smartwatch....
Valganciclovir, the ganciclovir prodrug, is an antiviral agent administered orally to prevent or treat cytomegalovirus infection in solid organ transplant recipients. Dosing regimen of valganciclovir still controversial children, as number patients reaching Area Under Curve at steady state (AUCss) target (40 - 60 mg.h/L) remains highly variable. The aim this study was determine population pharmacokinetics paediatric renal recipients and propose appropriate dosing regimen.Renal children who...
Objectives Parental consent for the participation of their neonate in neonatal research is influenced by quality information delivered and interaction between parents investigators. Failure to provide important may lead difficulties decision making process parents. This Delphi survey aims establish a consensus parent representatives associations healthcare professionals concerning deemed essential both parties order improve recruitment neonates into clinical trials. Method study was...
Valganciclovir, the ganciclovir prodrug, is an antiviral agent used to prevent cytomegalovirus infection in renal transplant children. Therapeutic drug monitoring still necessary ensure optimal therapeutic area under concentration-time curve from 0 24 h (AUC0-24) of 40 60 μg·h/mL since valganciclovir presents a high pharmacokinetic variability. To calculate AUC0-24 with trapezoidal method, 7 samples are needed. The objective this study was develop and validate reliable clinically applicable...
A survey was set up to gauge the opinions of neonatologists on role Ureaplasma in bronchopulmonary dysplasia (BPD) development, use azithromycin for BPD prevention and factors influencing European neonatal intensive care units (NICUs). 167 NICUs participated survey, representing 28 countries. For respondents, two major perceived risk were prematurity <28 weeks high oxygen requirements. Only 38% had a protocol 47% routinely tested Ureaplasma. In cases infection, macrolides first choice. Most...
PedCRIN is a Horizon 2020 project aimed to develop paediatric component of ECRIN (European Clinical Research Infrastructure Network) including tools supporting the conduct neonatal and trials. A structured, cross-sectional, closed-ended questionnaire was electronically administered from April May 2017 stakeholders involved in clinical research capture their needs receive infrastructural support cover specific gaps. The included 6 headings 29 subheadings. Each item evaluated using...
Background Neonatal trials remain difficult to conduct for several reasons: in particular the need study sites have an existing infrastructure place, with trained investigators and validated quality procedures ensure good clinical, laboratory practices a respect high ethical standards. The objective of this work was identify major criteria considered necessary selecting neonatal intensive care units that are able perform drug evaluations competently. Methodology Main Findings This Delphi...
Studies suggest that particular antimicrobial and anti-inflammatory properties of azithromycin (AZM) can be related to its extensive accumulation in white blood cells (WBCs). However, available methods for determination AZM WBCs require large volumes unsuited a pediatric context. Therefore, an LC-MS/MS method was developed WBCs.WBCs were isolated from 500 µl whole by lysing red cells. Then, lysis performed with methanol/buffer containing AZM-d3-(13)C as internal standard. After reversed...
Abstract Growth and maturation changes are mainly responsible for differences in drug pharmacokinetics pharmacodynamics observed between adults children, especially neonates. Ontogeny of drug‐metabolizing enzymes transporters plays an important role drugs interindividual pharmacokinetic variability but data limited both term preterm This study aimed to characterize mRNA expression the main transport proteins involved disposition, using umbilical cord blood ( UCB ), according gender,...
Background Multicenter neonatal clinical trials aim to provide evidence-based drug evaluation, but recruiting neonates requires collaboration, standard procedures, and trained neonatologists. Methods A questionnaire based on a previous Delphi study was sent European intensive care units (NICUs) collect their research experience identify areas for improvement. Results Of 247 NICUs,79 (32%) responded: 69 were level III 10 II units. In centers, 62% had medical staff dedicated 65% conducted...