77 results
To assess the PK/PD relationship of prednisolone as either prophylaxis or therapy of GVHD in children after HCT.
Primary:• To evaluate the safety of ORGN001 (formerly ALXN1101) over the first 6 months of treatmentSecondary:• To characterize the pharmacokinetics (PK) of increasing doses of ORGN001 (formerly ALXN1101) • To evaluate the effect of ORGN001 (…
The primary objective of the study is to assess the proportion of neonates with hyperbilirubinaemia necessitating treatment that is detected using universal TcB screening compared to using only visual inspection, while decreasing the number of heel…
Integrating genomic (WES/WGS) and other -omics technology in order to find the genetic cause, in 500 patients (children and adults) with an unexplained metabolic phenotype in whom standard care (genetic and metabolic evaluation) did not provide a…
The ultimate goal of our study is to reduce the amount of blood withdrawn for blood gas analysis, especially in the intensive care unit and in neonatal care by replacing regularly used 3 ml blood gas syringes with 1 ml blood gas syringes. The main…
Primary Objective:To investigate change in fat mass index between 6 and 12 months of age in infants receiving Nuturis® formula feeding versus standard formula feeding during the first 6 months of life.Secondary Objectives:- To investigate change in…
In 2004, a multidisciplinary team of clinicians and researchers in the UZ Leuven hospital started to collaborate on the rare problem of cancer during pregnancy. The collaboration between gynaecologists, pediatricians, hematologists, farmacologists,…
PrimaryTo evaluate the effect of DCR PHXC on estimated glomerular filtration rate (eGFR) in participants with PH1Secondary:To identify the proportion of participants with normalized or nearnormalized 24 hour urinary oxalate (Uox)2. To identify the…
The primary objective of this study is to describe the pharmacokinetics of antiretroviral agents, for which no or limited available pharmacokinetic data during pregnancy is available, in the 2nd, 3rd trimester of pregnant HIV-infected women and at 4…
PHASE 1 OBJECTIVES:Primary:To determine the safety of oral larotrectinib , including dose-limiting toxicity (DLT), in pediatric patients with advanced solid or primary central nervous system (CNS) tumors. PHASE 2 OBJECTIVES:Primary Objective:To…
Our main question is: How does GDM brain immaturity affect skills that are critical for later language development? To answer this question, we will assess two skills in GDM infants and compare them to term controls in two independent (separate)…
To evaluate whether in newborns with asphyxia and early clinical signs of hypoxic ischemic encephalopathy, early postnatal allopurinol compared to placebo administered in addition to standard of care (including therapeutic hypothermia if indicated)…
The aim of this pilot study, the *Ventilation, inflammation, perfusion and structure imaging in Neonatal Lung patients* (VINyL) study, is to develop a safe and fast MRI protocol for neonatal airway, lung and cardiac imaging in neonatal lung patients…
Primary aimTo determine the prevalence of children with hearing loss at time of discontinuation of cancer therapy in a prospective full cohort of 600 children with solid and CNS tumors.The secondary objectives of this study are:- To study the…
Primary objectiveTo establish whether saliva samples could be used as an alternative for blood samples in the therapeutic drug monitoring for amikacin and flucloxacillin. To meet this objective, a PK mod-el will be developed for amikacin and…
The primary objective of ALLTogether is to improve survival and quality of survival in children and young adults with acute lymphoblastic leukaemia
Objectives safety run-in: The primary objective is:• To assess the safety of i.v. teicoplanin prophylaxis three times per week with a two to three days interval in children with newly-diagnosed AML. A patient will be considered evaluable for safety…
Primary objective: To obtain a detailed immunological profile of children presenting to Dutch hospitals with acute SARS-CoV-2 infection or with a SARS-CoV-2 related post-infectious inflammatory syndrome. Secondary objectives: (1) To correlate the…
We aim to study the patient specific threshold for arterial blood pressure to maintain adequate cerebral perfusion (CBFV) in the perioperative setting and the association between perioperative abnormalities with postoperative brain damage and…
To quantify the strength and direction of interactions between important respiratory virus infections in young children