Bronchiolitis All-study, SE-Norway
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|ClinicalTrials.gov Identifier: NCT00817466|
Recruitment Status : Unknown
Verified November 2012 by Oslo University Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 6, 2009
Last Update Posted : November 2, 2012
|First Submitted Date ICMJE||January 5, 2009|
|First Posted Date ICMJE||January 6, 2009|
|Last Update Posted Date||November 2, 2012|
|Start Date ICMJE||January 2010|
|Primary Completion Date||June 2011 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||No of hours before deemed fit for discharge from hospital [ Time Frame: Throughout the hospital stay ]|
|Original Primary Outcome Measures ICMJE
||Clinical score (doctor assessed)every 24 hrs [ Time Frame: Prior to and 30 min. after inhalation ]|
|Change History||Complete list of historical versions of study NCT00817466 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
||Clinical status (by parents as well as nurses) every 12 hrs [ Time Frame: prior to inhalation every morning and evening ]|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Bronchiolitis All-study, SE-Norway|
|Official Title ICMJE||Bronchiolitis All-study, SE-Norway What is the Optimal Inhalation Treatment for Children 0-12 Months With Acute Bronchiolitis?|
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.
OVERALL AIMS OF THE STUDY:
METHODS AND STUDY PROGRESSION
This multicenter study will be performed after initial appropriate common training by all participating.
a. Treatment: Randomisation: block randomisation. Randomization will be performed by computer programs by the ORAACLE statistician, and provided to the Pharmacy preparing and labeling the vials for each patient.
Treatment: Nebulised racemic adrenaline vs saline throughout the hospital stay. Inhalations given on demand (parents/nurse) vs fixed x 4--12. Open saline inhalations may be given at any time, other inhalations is not allowed. Neither is systemic corticosteroids (which is not a proper treatment for acute bronchiolitis, according to Norwegian guidelines). All other treatment will be given according to usual local practice.
Clinical scores will be assessed before and 30 minutes after inhalation the first time, and subsequently once a day during ordinary doctor visit.
Global clinical assessment completed by nurses and parents will be done every morning and evening until discharge. Time at start, end and hours with naso-gastric tube feeding as well need for supplementary oxygen will be recorded daily and complications and adverse event will be recorded as they appear.
Nasopharynx aspiration is done at inclusion and is analysed by local routine, usually within 24 hours (except Sundays). Half of the aspirate will be frozen for batch PCR analyses at the virological laboratory (Oslo University Hospital) after all patients are enrolled.
Blood tests are sampled at inclusion. General analyses (see table 6) and sample to biobank for epigenetic analyses.
Saliva are sampled at inclusion and the following morning. Deemed fit for discharge will be decided by the attending physician. Minimum requirement is clinical score 3 or less at least 2 hours after last inhalation.
Urine tests are sampled at inclusion. Will be analysed at leukotrienes and arachidonic acid metabolites (eoxines) and other relevant inflammatory and infection markers.
Outcomes measured upon inclusion, after first inhalation (clinical score) as well as throughout the hospital stay according to flow-chart.
Main outcome: No of hours before deemed fit for discharge from hospital
Need for feeding support (no. of hours) Need for supplementary oxygen. Clinical score throughout admission Complications (presence of and time to confirmed) such as atelectasis Global assessments (parents and nurses) Need for ICU treatment Data from each hospital will in addition to collated data analysis be assessed independently.
Illness caused by different vira will be compared in regard to treatment efficacy.
b. Prognosis: This follow-up-study will be performed in collaboration between the principal investigator and the collaborating physicians at the local paediatric departments. The clinical follow-up visit includes a structured parental interview, application of the "Oslo severity score"20 for obstructive airways disease, assessment of atopic eczema and rhinitis, skin prick test as well as blood sampling for analyses including IgE and DNA for epigenetic studies (see table 4) .
c. Epidemiology: Retrospective study of all children 0-18 months admitted to hospital with the diagnosis of bronchiolitis. The study will mainly be a hospital registry study, but with 20% random chart scrutiny to ensure appropriateness of diagnosis.
Ammendment: Two further substudies were included;
a) Quality of life after bronchiolitis b) A population-based control group of 241 children from Oslo and Fredrikstad were included.
Since we established the "Bronchiolitis" cohort of children admitted to hospital for acute bronchiolitis, the prognostic perspective of this three-phase study has gained increasing focus. This relates in particular to immunological influence of different viral agents during the acute disease, as well as Quality of Life and the role of early "stress" in relation to development of allergic diseases in children with as well as without acute bronchiolitis in early life.
The aims are to assess physiological, immunological, environmental and "stress" (including psychosocial) factors in the development of allergic diseases, including asthma, atopic eczema, allergic rhinitis and allergies in children who have been hospital admitted due to acute bronchiolitis in infancy as well as children of the same age who have not been admitted for bronchiolitis.
Control children will be consecutively included at 2 Well-baby clinics in Fredrikstad and Oslo, respectively, total number 150 (100 + 150, respectively) ensuring similar variability of demographic data (age and ethnic background) as the enrolled bronchiolitis children. Inclusion will be assessed mid-way for adequate demographic variability.
Inclusion criteria: children 1- 11 months (inclusive) of age presenting to the Well-Baby Clinics, Exclusion criteria: Significant cardiac, previous severe respiratory disease, neurologic, immunologic, oncologic or other disease that may significantly influence the outcomes, including Down's syndrome.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||500|
|Estimated Completion Date||December 2013|
|Primary Completion Date||June 2011 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||up to 11 Months (Child)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Norway|
|Removed Location Countries|
|NCT Number ICMJE||NCT00817466|
|Other Study ID Numbers ICMJE||EudraCT 2009-012667-34|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Oslo University Hospital|
|Study Sponsor ICMJE||Oslo University Hospital|
|PRS Account||Oslo University Hospital|
|Verification Date||November 2012|
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