Bronchiolitis All-study, SE-Norway
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchiolitis |
Drug: Racemic adrenaline Drug: Isotonic saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Bronchiolitis All-study, SE-Norway What is the Optimal Inhalation Treatment for Children 0-12 Months With Acute Bronchiolitis? |
- No of hours before deemed fit for discharge from hospital [ Time Frame: Throughout the hospital stay ] [ Designated as safety issue: No ]
- Clinical status (by parents as well as nurses) every 12 hrs [ Time Frame: prior to inhalation every morning and evening ] [ Designated as safety issue: No ]
- Need for feeding support (no. of hours) [ Time Frame: Throughout the hospital stay. ] [ Designated as safety issue: No ]
- Need for supplementary oxygen. [ Time Frame: Throughout the hospital stay. ] [ Designated as safety issue: Yes ]
- Clinical score measured by doctor [ Time Frame: Throughout the hospital stay. Daily before and 30min after inhalation in daytime. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Racemic adrenaline, fixed intervals
Active drug with fixed intervals of inhalation, adjusted at least every 24h.
|
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. Other Name: Racemic adrenaline, racemic epinephrine, S2, vaponefrin, micronefrin
|
|
Experimental: Racemic adrenalin, on demand
Racemic adrenaline, inhalations on demand (max every 2 hrs)
|
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. Other Name: Racemic adrenaline, racemic epinephrine, S2, vaponefrin, micronefrin
|
|
Active Comparator: Saline, fixed intervals
Saline inhalation fixed intervals, adjusted at least every 24 hrs
|
Drug: Isotonic saline
2ml NaCl 9mg/ml.
Other Name: Isotonic saline. NaCl 0,9%. NaCl 9mg/ml.
|
|
Active Comparator: saline on demand
Saline inhalations on demand, max every 2 hrs, adjusted every 12 hrs
|
Drug: Isotonic saline
2ml NaCl 9mg/ml.
Other Name: Isotonic saline. NaCl 0,9%. NaCl 9mg/ml.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 11 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- children 0 inclusive 11 months admitted to the hospital with symptoms and signs of acute bronchiolitis during the winter season of 2009-11.
- bronchiolitis as defined on clinical criteria by SDM Court (Post graduate medical journal 1973).
- Clinical score of 4 or more (Kristjansson, Arch.Dis.Child. 1993)
Exclusion criteria:
- Use of regular inhaled corticosteroids.
- Use of systemic or inhaled corticosteroids within the last 4 weeks.
- Significant cardiac, previous severe or persisting (>4 weeks) respiratory disease, neurologic, immunologic, oncologic or other disease that may significantly influence the outcomes, including Down's syndrome. Prematurity per se is not a reason for exclusion.
- One single previous mild-moderate episode suspect of bronchial obstruction is not an exclusion criterion, >1 are.
Contacts and Locations| Norway | |
| Sykehuset Buskerud, Vestre Viken | |
| Drammen, Buskerud, Norway, N-3004 | |
| Sykehuset Innlandet, Elverum | |
| Elverum, Hedmark, Norway, NO-2409 | |
| Sykehuset Innlandet, Lillehammer | |
| Lillehammer, Oppland, Norway, N-2609 | |
| Sykehuset Telemark, Skien | |
| Skien, Telemark, Norway, N-3710 | |
| Sørlandet sykehus HF, Kristiansand | |
| Kristiansand, Vest-Agder, Norway, N-4604 | |
| Sykehuset Vestfold, Tønsberg | |
| Tønsberg, Vestfold, Norway, N-3103 | |
| Ullevaal University Hospital, department of Paediatrics | |
| Oslo, Norway, NO-0407 | |
| Oslo University Hospital, Rikshospitalet | |
| Oslo, Norway, N-0027 | |
| Sykehuset Østfold, Fredrikstad | |
| Fredrikstad, Østfold, Norway, N-1603 | |
| Study Director: | Karin C. Lødrup Carlsen, MD,pHD | Ullevål University Hospital HF |
| Principal Investigator: | Håvard O Skjerven, MD | Ullevål University Hospital HF |
More Information
Additional Information:
No publications provided by Oslo University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT00817466 History of Changes |
| Other Study ID Numbers: | EudraCT 2009-012667-34 |
| Study First Received: | January 5, 2009 |
| Last Updated: | November 1, 2012 |
| Health Authority: | Norway: Data Protection Authority Norway: Directorate of Health Norway: Norwegian Medicines Agency Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Oslo University Hospital:
|
bronchiolitis infants racemic adrenaline inhalations treatment |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Epinephrine Epinephryl borate Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 17, 2013