Academic Studies – Stand4Kids

ACADEMIC STUDIES

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One of the key goals of the Conect4Children consortium (c4c) is the selection and funding of Proof-of-viability (non-commercial and Industry) studies. On April 29, 2019, the selection of the pan-European pediatric academic studies was published:

TREOCAPA – Paracetamol in Premature Babies: Will assess the effectiveness of paracetamol in premature babies with a patent ductus arteriosus, and aims to recruit around 600 babies as part of the study (Lead: Prof. Jean-Christophe Roze of INSERM, a public research organization in Paris, France entirely dedicated to human health).
KD-CAAP – Steroids to Treat Kawasaki Disease: Will assess the effectiveness of adding steroids to standard treatment in children with Kawasaki Disease, and aims to recruit 262 children as part of the study (Leads: Dr. Despina Eleftheriou and Prof Paul Brogan of the University College of London (UCL), an academic research institution in the UK).

cASPerCF – Posaconazole in Children with Cystic Fibrosis: Will assess the dose of posaconazole in children and young people with Cystic Fibrosis and infection with Aspergillus and aims to recruit 130 children as part of the study (Lead: Prof. Adilia Warris of the MRC Centre for Medical Mycology, University of Aberdeen and Ospedale Pediatrico Bambino Gesù (OPBG), a children’s hospital in Rome, Italy).

In the tables below you can find detailed information on the TREOCAPA and cASPerCF Proof-of-viability (non-commercial and Industry) studies with participating Portuguese sites.

TREOCAPA

Sponsor	French National Institute of Health and Medical Research (INSERM)
Therapeutic Area	Paediatrics, Neonatology
Study Title	Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen
Study Acronym	TREOCAPA
Study Type	Interventional
CT Phase	Phase II/III
Nº EudraCT	2019-004297-26
EU Clinical Trials Register	LINK
ClinicalTrials.org	LINK
Number of Countries	17
Number of Sites (Portugal)	3
Portuguese sites and PIs	CHULN, EPE – HSM, André Graça, MD, PhD CHUP, EPE -CMIN, Elisa Proença, MD 2CA – Braga, Almerinda Pereira, MD
Target of Patients (Global)	Phase II: 30 Phase III: 794
Target of Patients (Portugal)	Phase III: 27
National Coordinator	André Graça, MD, PhD
Status	Recruitment

cASPerCF

Sponsor	Ospedale Pediatrico Bambino Gesu (OPBG)
Therapeutic Area	Paediatrics, Pulmonology
Study Title	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection
Study Acronym	cASPerCF
Study Type	Interventional
CT Phase	Phase II/III
Nº EudraCT	2019-004511-31
EU Clinical Trials Register	LINK
ClinicalTrials.org	LINK
Portugal Clinical Trials	LINK
Number of Countries	12
Number of Sites (Portugal)	1
Portuguese sites and PIs	CHULN, EPE -HSM, Celeste Barreto, MD
Target of Patients (Global)	Large screening phase: 1500 Intervention phase: 135
Target of Patients (Portugal)	Large screening phase: 25 Intervention phase: 4
National Coordinator	N/A
Status	Suspended in 2022