DEPARTMENT OF PEDIATRICS

INTRODUCTION

Our department treat sick children in 9 inpatient wards and in 17 specialist units. We have 313 employees (doctors, postgraduates, professional, administrative and physical staff). Our inpatient units: Internal Medicine unit (with a main profile in gastroenterology), Infectious Diseases unit, Intensive Care unit, "Dr. Mestyán Gyula" unit (diabetes, endocrinology, nephrology, otolaryngology profile), Neurology unit, Oncology unit, Pulmonology unit, Psychiatry unit, Surgery unit. We provide health care for children under the age of 18 in the county and the region, and have 157 beds.

Our outpatient units:
Metabolism and Endocrinology unit, Internal Medicine unit, Diabetes unit, EEG unit, Developmental Neurology unit, Otorhinolaryngology unit, Gastroenterology unit, Immunology unit, Nephrology unit, Neurology unit, Oncology unit, Pulmonology unit, Psychiatry unit, Surgical unit, Endoscopy unit and Manometry unit.

Our annual number of patients in 2021 was 88,113.

The Pediatric Clinic has more than two decades of experience in clinical trials. Currently 5 principal investigators and 6 investigators participate in clinical trials. We are happy to undertake clinical trials in all our specialist areas.

Preferred research areas: epilepsy, headache, migraine, autoimmune neurological diseases; composition of breast milk, examination of fatty acids; childhood obesity, high blood pressure; type 1 and type 2 diabetes; childhood endocrinological diseases and conditions (growth hormone, puberty disorders, syndromes); active treatments of childhood malignant diseases, communication challenges of pediatric palliative care, treatment of childhood kidney tumours, Wilms tumor chemosensitivity tests; pediatric surgery, pediatric urology; immunological diseases,
gastroenterological diseases (inflammatory bowel diseases), pulmonological diseases (asthma bronchiale).

Number of clinical trial investigators with a Good Clinical Practice (GCP) certificate : 5
Number of clinical trial doctors with Good Clinical Practice (GCP) certificate: 6
Number of specialist doctors with Clinical Pharmacology certificate: 0

EQUIPMENT FOR CLINICAL TRIALS

freezer, - 80°C
ultrasound device
laboratory equipment (centrifuges, chromatograph)
indirect calorimeter (to measure metabolism)
X-ray examination facilities
scale suitable for measuring body weight over 200 kg
Holtain stadiometer (with calibration)
bioelectrical impedance meter? (BIA)
blood pressure meter,
24-hour ambulatory blood pressure meter (ABPM)

REFERENCE CLINICAL TRIALS

	Protocol Identifier	Name of Study	Principal Investigator
1	QLK1-CT-1999-00888	Fatty acid supplementation in pregnancy; phase III	Prof. Dr. Tamás Decsi
2		Oligosaccharide supplementation in children, phase III	Prof. Dr. Tamás Decsi
3	EMR 200104_528	Easypod Connect: a nationwide, multicenter observational study to evaluate the relationship between therapeutic efficacy and long-term outcomes of therapy in children treated with growth hormone using the Easypod TM electromechanical device	Dr. Éva Erhardt
4	EFC 13957	Six-month, multicenter, randomized, open, two-arm, parallel group study of the efficacy and safety of a new formulation of once-daily insulin glargine and Lantus. Comparative study for children and adolescents aged 6-17 who suffer from Type 1 diabetes with six-month safety extension.	Dr. Éva Erhardt
5	105MS306	Phase III, open, randomized, multicentre, active preparation-controlled, parallel group study for BIIB017. To evaluate safety, tolerance and effectiveness in the treatment of relapsing-remitting multiple sclerosis, in the case of pediatric patients who have reached the age of 10 but are under the age of 18, optional open with extension.	Dr. Katalin Hollódy
6	EISAI E2007-G000-311	Phase III, international, open trial of preampanel with an extended phase in the hospitals of the United States, Europe and Asia Pacific. The clinical trial is for assessing the safety and tolerability of an perampanel in children aged 4-12 years with epilepsy suffering from primary generalised tonic-clonic seizures or poorly controlled partial seizures.	Dr. Katalin Hollódy
7	A3921210	Open-label induction and placebo-controlled double-blind randomized maintenance study of oral CP-690,550 (tofacitinib) in children with moderate to severe ulcerative	Dr. András Tárnok
8	A3921241	Open-label long-term extension study of tofacitinib in children with ulcerative colitis	Dr. András Tárnok
9	D4280C00015	A single-blind, randomized, multicentre active agent-controlled study of the safety and tolerability of ceftazidime and avibactam treatment used together with metronidazole, for the evaluation of its pharmacokinetics and efficacy compared to meropenem, in children aged 3 months but younger than 18 years, with complicated intra-abdominal infections (complicated intra-abdominal infections, cIAIs).	Dr. László Péter Vajda
10	IG1405/254	A prospective, randomized, active-controlled, single-blind, parallel-group clinical trial to evaluate the safety and efficacy of Grifols fibrin glue as an adjunct to hemostasis during operations on children.	Dr. László Péter Vajda

OUR PUBLICATIONS

Catena A, Muñoz-Machicao JA, Torres-Espínola FJ, Martínez-Zaldívar C, Diaz-Piedra C, Gil A, Haile G, Györei E, Molloy AM, Decsi T, Koletzko B, Campoy C: Folate and long-chain polyunsaturated fatty acid supplementation during pregnancy has long-term effects on the attention system of 8.5-y-old offspring: a randomized controlled trial. Am J Clin Nutr 103(1): 115-27, 2016.

Molnar D, Torok K, Erhardt E, Jeges S: Safety and efficacy of treatment with an ephedrine/caffeine mixture. The first double-blind placebo-controlled pilot study in adolescents. Int J Obes 24: (12) pp. 1573-1578, 2000

Chatelain P, Malievskiy O, Radziuk K, Senatorova G, Abdou MO, Vlachopapadopoulou E, Skorodok Y, Peterkova V, Leff JA, Beckert M; TransCon GH Working Group: A randomized phase 2 study of long-acting TransCon GH vs daily GH in childhood GH deficiency. J Clin Endocrinol Metab 102(5): 1673-1682, 2017

Ottóffy G, Horváth P, Muth L, Sólyom A, Garami M, Kovács G, Nyári T, Molnár D, Pauler G, Jankovics I. Immunogenicity of a 2009 pandemic influenza virus A H1N1 vaccine, administered simultaneously with the seasonal influenza vaccine, in children receiving chemotherapy. Pediatr Blood Cancer. 61(6):1013-1016, 2014

PRINCIPAL INVESTIGATORS

Prof. Dr. Tamás Decsi
SCIENTIFIC DEGREE	PhD, Habil, MTA doktora
POSITION	University Professor
QUALIFICATIONS	Pediatrician Neonatology
SCIENTIFIC INTEREST	breast milk, fatty acids
REFERENCE CLINICAL TRIALS	QLK1-CT-1999-00888: Fatty acid supplementation in pregnancy; phase III, approx. 300 patients included Oligosaccharide supplementation in children, phase III, number of patients included: approx. 300 involved
WHAT EXAMS DOES IT UNDERTAKE	Phase 1-3

Dr. Éva Erhardt
SCIENTIFIC DEGREE	PhD, Habil
POSITION	University Associate Professor
QUALIFICATIONS	Infant and Pediatric Medicine, Endocrinology, Diabetology, Obesitology
SCIENTIFIC INTEREST	childhood obesity, high blood pressure; type 1 and type 2 diabetes; childhood endocrinological diseases and conditions (growth hormone, puberty disorders, syndromes)
REFERENCE CLINICAL TRIALS	EMR 200104_528: Easypod Connect: a nationwide, multicenter observational study to evaluate the relationship between therapeutic intensity and long-term outcomes of therapy in children receiving growth hormone therapy with the Easypod TM electromechanical device. Number of patients included: 8 EFC 13957: Six-month, multicenter, randomized,open, two-arm, parallel group study of the efficacy and safety of a new formulation of once-daily insulin glargine and Lantus. Comparative study for children and adolescents aged 6-17 who suffer from Type 1 diabetes with six-month safety extension. Number of patients included: 2
AVAILABLE FOR PERFORMING CLINICAL TRIALS	Phase 2-4

Prof. Dr. Katalin Hollódy
SCIENTIFIC DEGREE	PhD, Habil.
POSITION	Head of Department, University Professor
QUALIFICATIONS	Infant and pediatric medicine, Pediatric Neurology, Clinical electrophysiology
SCIENTIFIC INTEREST	childhood neurological diseases
REFERENCE CLINICAL TRIALS	105MS306: pHASE III open-label, randomized, multicentre, active agent-controlled, parallel-group study to evaluate the safety, tolerability and efficacy of BIIB017 for the treatment of relapsing-remitting multiple sclerosis in pediatric patients aged 10 years old but under 18 years old, with optional open-label extension. EISAI E2007-G000-311: Phase III, international, open trial of preampanel with an extended phase in the hospitals of the United States, Europe and Asia Pacific. The clinical trial is for assessing the safety and tolerability of an perampanel in children aged 4-12 years with epilepsy suffering from primary generalised tonic-clonic seizures or poorly controlled partial seizures.
AVAILABLE FOR PERFORMING CLINICAL TRIALS	Phase 3-4

Dr. András Tárnok
SCIENTIFIC DEGREE	PhD, med Habil
POSITION	university associate professor
QUALIFICATIONS	Infant and pediatric medicine, Gastroenterology
SCIENTIFIC INTEREST	pediatric gastroenterology
REFERENCE CLINICAL TRIALS	A3921210, Open-label induction and placebo-controlled double-blind randomized maintenance study of oral CP-690,550 (tofacitinib) in children with moderate to severe ulcerative colitis who failed prior therapy A3921241, Open-label long-term extension study of tofacitinib in children with ulcerative colitis
AVAILABLE FOR PERFORMING CLINICAL TRIALS	Phase 2-4

Prof. Dr. László Péter Vajda
SCIENTIFIC DEGREE	PhD, med Habil
POSITION	University Professor, Head of Department
QUALIFICATIONS	pediatric surgery, fellow of European board of pediatric surgery, fellow of European board of pediatric urlogy
SCIENTIFIC INTEREST	pediatric surgery, pediatric urology
REFERENCE CLINICAL TRIALS	D4280C00015 (Astra Zeneca), 2016-17. Number of patients included: 2, Principal Investigator MK-7625A PN035 (MSD), from 2018, Number of patients involved: 0, Investigator IG 1405 (Grifols Inc.), from 2018, Number of patients involved: 6, Principal Investigator
AVAILABLE FOR PERFORMING CLINICAL TRIALS	Phase 3-4

STUDY TEAM

Study Coordinators

The clinic currently does not have its own coordinator and study nurse. You need to contact the Coordination Centre for Clinical Trials (KVKK)

Study Nurses

Our clinic currently has 12 study nurses.

Number of study nurses with master degree (MSc): 0
Number of study nurses with bachelor degree (BSc): 2
Number of study nurses with further education degree: 8

Name	Phone	Email
Katalin Hermesz-Harangozó	+36 72 536 000 / 38811	harangozo.katalin@pte.hu
Erika Erdősiné Hajós	+36 72 536 000 / 38797	hajos.erika@pte.hu
Ibolya Bot	+36 72 536 000	bot.ibolya@pte.hu
Melinda Mihály	+36 72 536 000 / 38797	mihaly.melinda@pte.hu
Nóra Ottné Puskás	+36 72 536 000 / 38920	ottne.nora@pte.hu
Bettina Kromperger	+36 72 536 000 / 38742	kormperger.bettina@pte.hu
Orsolya Éger	+36 72 536 000 / 38725	eger.orsolya@pte.hu
Ildikó Kőröshegyi	+36 72 536 000 / 38862	koroshegyi.ildiko@pte.hu
Ágnes Cvenitsné Árkus	+36 72 536 000 / 38711	arkus.agnes@pte.hu
Annamária Zsupán Bolvárnié	+26 72 536 000 /38773	zsupan.annamaria@pte.hu

Created: 20.11.2019.
Last modified: 20.11.2019.

DEPARTMENT OF PEDIATRICS

Open-label induction and placebo-controlled double-blind randomized maintenance study of oral CP-690,550 (tofacitinib) in children with moderate to severe ulcerative