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Open Access Study protocol

Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial)

Karin B Fieten12, Wieneke T Zijlstra13, Harmieke van Os-Medendorp1, Yolanda Meijer4, Monica Uniken Venema5, Lous Rijssenbeek-Nouwens2, Monique P l’Hoir6, Carla A Bruijnzeel-Koomen1 and Suzanne GMA Pasmans17*

Author Affiliations

1 Department of (Pediatric) Dermatology and Allergology, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands

2 High altitude clinic Merem Dutch Asthma Center Davos, Herman-Burchardstrasse 1, CH-7265 Davos, Switzerland

3 Department of Pediatrics, Onze Lieve Vrouwe Gasthuis, Oosterpark 9, 1091 AC Amsterdam, The Netherlands

4 Department of Pediatric Pulmonology and Allergology, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Lundlaan 6, 3584 EA, Utrecht, The Netherlands

5 Department of Pediatric Psychology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Lundlaan 6, 3584 EA, Utrecht, The Netherlands

6 TNO Prevention and Health, Zernikedreef 9, 2333 CK Leiden, The Netherlands

7 Department of Pediatric Dermatology, Sophia Children’s Hospital and KinderHaven, Erasmus University Medical Center, Wytemaweg 80, 3015 CN Rotterdam, The Netherlands

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Trials 2014, 15:94  doi:10.1186/1745-6215-15-94

Published: 26 March 2014

Abstract

Background

About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking.

Methods/Design

This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children’s Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children’s Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters.

Discussion

The results of this trial will provide evidence for the efficacy of high altitude treatment compared to treatment at sea level for children with moderate to severe AD.

Trial Registration

Current Controlled Trials ISRCTN88136485.

Keywords:
Atopic dermatitis; Atopic eczema; Asthma; Atopic syndrome; Children; Coping; Quality of life; High altitude treatment; Multidisciplinary treatment; RCT