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CHIP-AML22 Master protocol: An open label complex clinical trial in newly diagnosed pediatric de novo AML patients - a study by the NOPHO-DBSHIP consortium

This study has been transitioned to CTIS with ID 2023-504999-25-00 check the CTIS register for the current data. To investigate wether the treatment of children and adolescents with AML can be improvedby means of:1) improved risk-group adapted…

Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)

This study has been transitioned to CTIS with ID 2023-508926-91-00 check the CTIS register for the current data. To determine non-inferiority of preoperative 6 weeks of VCE to VAD in the overall metastatic rapid response rate (MetRR) in newly…

Influence of Positive End-Expiratory Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children

To measure cardiac output at various levels of Positive End Expiratory Pressure (PEEP).

CHIP-AML22/Quizartinib: A phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric FLT3-ITD positive and NPM1 wild type AML patients.
(A linked-trial of the CHIP-AML22/Master protocol by the NOPHO-DB-SHIP consortium)

This study has been transitioned to CTIS with ID 2023-505000-27-01 check the CTIS register for the current data. To investigate the safety and efficacy of quizartinib in children and adolescents with newly diagnosed FLT3-ITD positive AML with normal…

A longitudinal prospective, observational, cohort study in lactating mothers and their newborns to further unravel the complexity of human milk

The objective of this study is to further unravel the complexity of human milk and its variations over lactation stages and between individuals.

European Newborn Study: Early Markers for a Better LifE

Primary Objective: to develop and evaluate a machine learning (ML) prediction model of brain injury in neonates at high-risk for CP to predict motor, behavioral, and cognitive outcome more accurately.This aim will be achieved by: developing and…

Optimization of spleen VCTE examinations with FibroScan

Main objective : To develop a spleen examination dedicated to overweight or obese patients and assessits applicability.Secondary objectives :1. Develop a spleen exam dedicated to patients usually measured with the S+ probe and assess its…

Objective Neurocognitive assessment of young children with sickle cell disease by eye-tracking

The main aim is to study early neurocognitive functioning and development in very young children with SCD. The secondary aims are to identify determinants (risk and protective factors) and biomarkers of early neurocognitive deficits in SCD and to…

International proof of concept therapeutic Stratification trial of Molecular Anomalies in Relapsed or Refractory HEMatological malignancies in children. Sub-Protocol D: Trametinib + Dexamethasone
+ Cyclophosphamide and Cytarabine in pediatric patients with relapsed or refractory hematological malignancies

This study has been transitioned to CTIS with ID 2022-501869-41-00 check the CTIS register for the current data. PrimaryPhase I: To assess the safety and tolerability of the investigational agents and define the MTD/RP2D(s)Phase II: To evaluate the…

A Prospective, Observational, Basket, Comprehensive Cohort Study of Children and Adolescents Aged Less Than 18 Years with Anemia Associated with Chronic Kidney Disease Requiring or Not Requiring Dialysis.

Primary:Evaluate the impact of SoC anemia management on Hgb concentrationsSecondary:- Characterize the use of ESA therapies in management of anemia associated with moderate to severe CKD in children and adolescents aged <18 years- Evaluate…

A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

This study has been transitioned to CTIS with ID 2024-510742-13-00 check the CTIS register for the current data. The primary objective is to compare the objective response rate (ORR) assessed per Response Assessment in Neuro Oncology for low-grade…

A Randomized, Multi-Center Phase III Trial comparing two conditioning regimens (CloFluBu and BuCyMel) in children with Acute Myeloid Leukemia undergoing allogeneic stem cell transplantation.

This study has been transitioned to CTIS with ID 2023-505512-37-00 check the CTIS register for the current data. The primary objective of the randomized part of the protocol is to investigate if a conditioning regimen containing one alkylator (Bu)…

Evaluation of the outcome of clinical or home introduction of milk in children with Non-IgE-mediated cow*s Milk Allergy (ENIGMA trial)*

The aim of this study is to compare the outcome of a clinical challenge test and home introduction of cow*s milk for children with a suspected non-IgE-mediated cow*s milk allergy. We want to evaluate the ability of both tests to determine the…

Adding DNA-test for screening of HLA-DQ2 and DQ8 to improve the early diagnosis of celiac disease at the Dutch Preventive Youth Healthcare Centres

Primary Objective:1. To validate the HLA-DQ typing in blood taken by a fingerprick; to make it feasible in the regular Preventive YHCCs organization.2. To establish the feasibility of HLA-DQ2/8 typing in the active case-finding at the Preventive…

Child Brain Lab Circuit

Objectives: 1) Create shared and disease-specific developmental curves with relevant and meaningful outcomes in children with brain-related disorders. 2) Develop innovative paradigms and parameters from neurophysiological, brain structure and motor…

Paediatric Inflammatory Bowel Diseases Network for Safety, Efficacy, Treatment and Quality improvement of care: The PIBDNet inception cohort and safety registry

The primary objective of the PIBD-NET inception cohort is to search for factors predictive for outcome, specific severe adverse events (SAEs) and for predictors of response or non-response to therapy. The secondary objective is the identification of…

EuroNet-Paediatric Hodgkin*s Lymphoma Group ;Second International Inter-Group Study
for Classical Hodgkin*s Lymphoma in Children and Adolescents

The aim of this study is to reduce the indication for RT without compromising cure rates. To investigate if intensified consolidation therapy (DECOPDAC-21) compared to standard consolidation therapy (COPDAC-28) can compensate for reduction in RT.

A non-traditional complex intervention for the treatment of paediatric sleep problems

The primary objective of the cohort study is to test the effectiveness of a complex intervention of paediatric sleep problems on a 24-hour sleep duration (day- and nighttime) of children aged 6-36 months of age with sleep onset and/ or sleep…

Prospective Observational study Comparing Electromyography of the Diaphragm with Ultrasound in neonates and children with Respiratory Support: the PROCEDURES study

Our objective is to assess the association between transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) in the PICU population.

EUROPEAN STUDY OF THE CEREBELLAR MUTISM SYNDROME (CMS) IN CHILDREN WITH BRAIN TUMOURS OF THE POSTERIOR FOSSA

The purposes of this study are to uncover1. Which surgical methods are least likely to cause the CMS and if there is a difference in risk between primary surgery andreoperation2. Which patients may be genetically predisposed to developing the CMS 3…