Bronchiolitis All-study, SE-Norway

Summary

Bronchiolitis is a common lower respiratory disease typically affecting infants and children generally younger than 2 years of age. The disease leads to hospital admissions, is a major cause for hospitalisation of young children and infants during winter epidemics, may be severe sometimes requiring ventilatory support and rarely death. The clinical disease as described by Court is characterised by nasal flaring, tachypnoea, dyspnoea, chest recessions, crepitations and sometimes sibiliations. Respiratory Syncytial virus is the most common cause, but also other respiratory vira may cause the disease. Bronchiolitis is a well known risk factor of asthma development in childhood1,2.

Management is generally supportive, whereas symptom reducing therapy is debated with no international consensus. Furthermore, there are many unresolved questions related to the prognosis of bronchiolitis, its role in development of chronic lung disease in particular regarding the association between early bronchiolitis and asthma development. The present project will particularly focus on: 1)Treatment efficacy related to various outcomes during active disease, 2) retrospectively assess treatment efficacy in relation to later development of allergic disease, 3) assess the role between different vira and asthma prognosis as well as 4) identify possible prognostic factors involved in the progression from bronchiolitis to further airways disease.

Conditions

• Bronchiolitis

Interventions

DRUG

Racemic adrenaline

For inhalation. Dosing (as in previous study): 1\) 0,1ml\<5kg, 0,15ml 5-6,9kg, 0,20ml 7-9,9kg, 0,25ml \>10kg of racemic adrenaline 20mg/ml diluted in 2ml NaCl 9mg/ml.3 Maximum 12 inhalations/24 hours. One bottle (10ml) per patient. The bottles will be marked with the name of the study and a randomisation number.

DRUG

Isotonic saline

2ml NaCl 9mg/ml.

Sponsors & Collaborators

• University of Oslo

  collaborator OTHER

• Ostfold University College

  collaborator OTHER

• Vestre Viken Hospital Trust

  collaborator OTHER

• Sykehuset i Vestfold HF

  collaborator OTHER

• Sykehuset Telemark

  collaborator OTHER_GOV

• Sorlandet Hospital HF

  collaborator OTHER_GOV

• Sykehuset Innlandet HF

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Karin C. Lødrup Carlsen, MD,pHD · Ullevål University Hospital HF

• Håvard O Skjerven, MD · Ullevål University Hospital HF

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Max Age

11 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2011-06-30

Completion

2013-12-31

Countries

• Norway

Study Locations