BeNeFIT18554: Bronchodilatatorische Behandlung keuchender Kleinkinder in der primären Gesundheitsversorgung: eine multizentrische, randomisierte, plazebokontrollierte, parallele Gruppenstudie - KIWI-Studie

Bronchodilators for wheeze in young children presenting to primary care: a randomised, placebo-controlled, multicentre, parallel group trial

Participants (P)

Children who are otherwise healthy, aged 6-24 months, who present with physician-diagnosed wheeze at their GP/paediatrician’s surgery and have a baseline respiratory symptom score of at least 7 out of 18.

Intervention (I)

Salbutamol inhalation 4 times 200ug for 7 days

Control (C)

Placebo inhalation 4 times per day for 7 days

Outcome (O)

The course of the mean parent reported respiratory symptom score over 5 days

Trial Design

A primary care based, randomised, placebo-controlled, multicentre, parallel group trial

Sample Size

300 children (150 in The Netherlands, 150 in Belgium)

Trial duration

Budget

The Netherlands: 979,067 € including VAT

Belgium: 455,177 € including VAT

Status

Open

Sponsor

University Medical Center Utrecht

Coordinating centre: University hospital Leuven

Chief Investigator

Roger Damoiseaux

National Coordinator BE: Ann Van den Bruel

Trial coordinator

Alma van de Pol

Sites

The Netherlands: 20 GP practices

Belgium: 20 sites which are either GP practices or community based paediatricians

External Partners

Liège Université, Unité de Recherche “Soins primaires et Santé

Maastricht University, Faculty of Health, Medicine and Life Sciences/ School Caphri, Care and Public Health  Research Institute/ Department of Family Medicine

Universiteit Antwerpen