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0900 712 712

(3.23 CHF / min. from the Swiss landline, possibly additionally 8 Rp. / min. by network operator)

0900 712 713

(3.13 CHF / min. for calls from prepaid cell phones, possibly additionally 8 Rp. / min. by network operator)

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KIDS-STEP Study

KIDS-STEP

The aim of the KIDS-STEP trial is to investigate if anti-inflammatory medication (steroids) positively affect the severity of illness in children with lower airway infections (chest infection, pneumonia). This will be investigated in children admitted to hospital with a chest infection who receive standard therapy.

The KIDS-STEP trial investigates if we can observe

a less severe disease
a shorter duration of illness
a shorter hospital stay
less complications

in children who receive steroids.

KIDS-STEP-Studie: deutsche Version

KIDS-STEP STUDY english version

L'édude KIDS-STEP: version française

Participating hospitals in Switzerland

Aarau

Principal Investigator Aarau
Prof. Dr. med. Henrik Koehler
Oberarzt päd. Pneumologie
Kantonsspital Aarau AG, Klinik für Kinder u. Jugendliche, Tellstr. 25, 5001 Aarau
T +41 62 838 92 44

Co-Investigator Aarau
Patrick Haberstich

Study Team Aarau
Rachel Kusche
Sandra Knecht

Basel

Principal Investigator Basel
Prof. Dr. med. Ulrich Heininger, MD
E-Mail

Study Team Basel - Pediatric Research Centre (PRC)
Claudia Werner
Britta Wagner
Alexandra Meyer
Artemis Ioannaki

Bern

Principal Investigator Bern
Kristina Keitel
Inselspital Bern, Notfallzentrum für Kinder und Jugendliche
Freiburgstrasse 15, 3010 Bern

Study Team Bern
Verena Wyss
Barbara Beck
E-Mail

Fribourg

Principal Investigator Fribourg
Dr. Petra Zimmermann
Pädiatrie - HFR Freiburg – Kantonsspital
Chemin des Pensionnats 2-6 | 1752 Villars-sur-Glâne
T +41 26 306 35 10

Study Nurse Fribourg
Julie Tomasini
T +41 26 306 35 98

Genf

Principal Investigator Genf
Dr. med. Anne Mornand
Geneva University Hospital, Department of Pediatrics
rue Willy Donzé 6, 1211 Geneva 14
T +41 22 372 45 79

Co-Investigator Genf
Klara Posfay-Barbe

Research Coordinator Genf
Renato Gualtieri

Luzern

Principal Investigator Luzern
Marco Lurà, MD
Oberarzt Pädiatrie
Luzerner Kantonsspital, Kinderspital, Spitalstrasse, 6000 Luzern 16
T +41 41 205 68 38
M +41 79 550 89 38

Co-Investigator Luzern
Alex Donas

Study Team Luzern
Katja Hrup
Janine Stritt

St. Gallen

Principal Investigator St. Gallen
Dr. Christian Kahlert
Oberarzt Infektiologie
Claudiussstrasse 6, 9006 St. Gallen
T +41 71 243 14 34

Study Coordinator St. Gallen
Ingrid Beck
T +41 71 243 19 67

Zürich

Principal Investigator Zürich
Christoph Berger, MD
Leiter Abteilung Infektiologie und Spitalhygiene
Universitäts-Kinderspital Zürich – Eleonorenstiftung, Steinwiesstrasse 75, 8032 Zürich
T +41 44 266 78 40 (direkt)
T +41 44 266 72 50 (Sekretariat)
F +41 44 266 80 72

Co-Investigator Zürich
Dr. med. Patrick Meyer Sauteur
Oberarzt Infektiologie und Spitalhygiene
T +41 44 266 78 96

Participating hospitals in Germany

Bochum

Principal Investigator Bochum

Dr. med. Stefanie Dillenhöfer
Oberärztin Pädiatrische Pneumologie
Universitätsklinikum der Ruhr-Universität Bochum
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum
Alexandrinenstr.
544791 Bochum

Co-Investigator Bochum
Dr. med. Anne Schlegtendal
Fachärztin

Study Team Bochum
Dr. med. Anna Wiemers
Sub Investigator

Study Nurses:
Sandra Böger
Michaela Schwarzbach
Veronika Baumeister
Barbara Streich

Düsseldorf

Principal Investigator Düsseldorf
Dr. med. Dirk Schramm
Oberarzt
Bereich Kinder-Pneumologie und Allergologie
Universitätsklinikum Düsseldorf
Moorenstrasse 5
40225 Düsseldorf
T +49 211 81 00

Study Team Düsseldorf
Dr. rer. nat. Nadja Drusenheimer
Dr. rer. nat. Anne Brückner

Freiburg

Principal Investigator Freiburg
Prof. Dr. Markus Hufnagel
Leitung Kinder- und Jugendrheumazentrum
Stv. Leitung Pädiatrische Infektiologie und Rheumatologie, Immunologie
Klinik für Allgemeine Kinder- und Jugendmedizin
Postadresse: Mathildenstrasse 1 / Anfahrt: Heiliggeiststrasse 1
79106 Freiburg
T +49 761 270 45 29 2

Co-Investigator Freiburg
Dr. Roland Elling

Study Coordinator Freiburg
Bianca Rippberger

Tübingen

Principal Investigator Tübingen
Dr. Tobias Walter
Oberarzt
Facharzt für Kinder und Jugendmedizin, Zusatzbezeichnung Kinder-Pneumologie
Notaufnahme, Asthma/Allergiesprechstunde

T +49 7071 29-83781

Co-Investigator Tübingen
Dr. med. Hanna Renk
Funktionsoberärztin, Fachärztin für Kinder- und Jugendmedizin
Pädiatrische Infektiologie; Pädiatrische Intensivmedizin
Universitätsklinikum Tübingen, Postfach 2669, 72016 Tübingen
T +49 7071 29-62250

Study Team Tübingen
Annette Hark
T +49 7071 29-81397

Hiltrud Mayer
SusanneSchwartz
Irmgard Müller

Number of participants KIDS-STEP Study

510

Participating hospitals in Switzerland

kidsstep - kids-step - kidstep-studie - Teilnehmende Spitäler in der Schweiz

Participating hospitals in Germany

Background

Participant selection

Procedure

Study organisation

Background

Lung infections are a common reason for children having to stay in hospital. Based on already known information on the effect of cortisone in lung infections, the severity of the disease in children may be reduced by cortisone and the hospital stay of children may be shortened. In children, there is still no significant data for the beneficial use of cortisone in lower respiratory tract infections. This is why we would like to evaluate this in our trial.

Participant selection

Participation is open to all children who are admitted to hospital (at a participating center) for a chest infection and who are between 6 months and 13 years of age and weigh between 5 and 45 kilograms.

Children are prohibited from participation if they suffer from a severe chronic condition (e.g. mucoviscidosis), have a severe complication (e.g. a large fluid collection in their chest) or if they are known to be allergic to betamethasone or any additional ingredients in Celestamine®.

Procedure

KIDS-STEP is a randomised, placebo-controlled and double-blind trial. This means that the participating children are randomly split into two groups (Celestamine® group and placebo group). Children in the Celestamine® group receive medication that contains the active ingredient and children in the placebo group receive medication that does not contain an active ingredient. A child will be randomly assigned to one of the groups (randomisation). This means that it is due to chance whether a child will receive Celestamine® or placebo. Neither the parents nor the trial team can decide which group a child will be assigned to. The chance to be assigned to each group is the same (50%).

Irrespective of group allocation a nasal swab will be taken from every participating child on day 1 and 3. For this a cotton bud will be placed in the child’s nose for a few seconds to collect nasal secretions. These nasal secretions can then be tested in the lab for viruses and bacteria that can be associated with lower airway infections.

After regular discharge from hospital a trial team member will call a family member 1, 2 and 4 weeks after joining the trial and will ask a few questions about the child’s health and wellbeing. After the call in week four the child‘s participation ends.

Several hundred children in Switzerland and Germany will participate in the KIDS-STEP study throughout the duration of the study.

The KIDS-STEP study is carried out within the SwissPedNet research network. SwissPedNet coordinates and supports high-quality research in child health. All major children's hospitals and university children's hospitals in Switzerland will participate in the KIDS-STEP study.