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Exercise induced bronchoconstriction after hospitalisation for lower respiratory tract infection in infancy.


- candidate number10516
- NTR NumberNTR3135
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-nov-2011
- Secondary IDsNL 38731.000.12 CCMO
- Public TitleExercise induced bronchoconstriction after hospitalisation for lower respiratory tract infection in infancy.
- Scientific TitleEIB after VLRTI.
- ACRONYMEIB VLRTI
- hypothesisThe aim of this study is to investigate the prevalence of exercise induced bronchoconstriction (EIB) in young children with a history of hospitalisation for VLRTI, using a newly designed exercise provocation challenge adjusted to the specific age-related course of EIB.
- Healt Condition(s) or Problem(s) studiedBronchiolitis, Asthma, Lower respiratory tract infections, Exercise induced Asthma, Exercise induced bronchoconstriction
- Inclusion criteria1. History of hospitalisation for viral lower respiratory tract infection (VLRTI) <2 years of age (children will be recruited from the VLRTI-cohort);
2. Age 5 through 7 years;
3. Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%;
4. Clinically stable period at least 4 weeks before the study period (no hospital admission or use of systemic corticosteroids).
- Exclusion criteria1. Use of systemic corticosteroids in the last 4 weeks prior to the study;
2. Use of long acting bronchodilators 24 hours before testing;
3. Use of short acting bronchodilators 8 hours before testing;
4. Use of leukotriene antagonists 24 hours before testing;
5. Comorbidity (other pulmonary or cardiac disorder, mental retardation/motor dysfunction).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2011
- planned closingdate1-mei-2012
- Target number of participants120
- InterventionsNo intervention, other than an exercise provocation challenge, will be investigated. An exercise provocation challenge is part of the routine clinical evaluation of patients with exercise induced symptoms or asthma. However, an exercise provocation challenge in the evaluation of asthmatic children aged 5 through 7 years isnít widely used and can therefore be seen as an intervention. Thus the intervention used in our study is a newly designed exercise provocation challenge.
This exercise provocation challenge exists of jumping on a jumping castle for at least 4 minutes (target is a 6 minute lasting exercise at 80% of the predicted maximum heart rate). Before, during and after exercise, patients perform pulmonary function measurements (flow volume curves).
- Primary outcomePrimary outcome of this study is to investigate the prevalence of EIB in young children with a history of hospitalisation for VLRTI. Primary parameter is the percent change in pulmonary function (FEV1, FEV0.5 and FEF50) during and post-exercise in young children, hospitalised in infancy with VLRTI.
- Secondary outcome1. Prevalence of EIB in young children with a history of hospitalisation for VLRTI with regard to different pathogens (especially RSV versus RV);
2. Analysis of anthropometric measures, clinical features, medication use and history of young children with a history of hospitalisation for VLRTI;
3. Investigate whether the prevalence of asthma in young children with a history of hospitalisation for VLRTI significantly differs from the prevalence of asthma in the general population (based on literature data).
- TimepointsOne visit. Children with a negative exercise provocation challenge will be invited to a second challenge on another day.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES J.C. Leeuwen, van
- CONTACT for SCIENTIFIC QUERIES J.C. Leeuwen, van
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Stichting Pediatrisch Onderzoek Enschede
- PublicationsN/A
- Brief summaryHospitalisation for bronchiolitis in infancy is a well-known risk factor for later asthma. Bronchiolitis is a viral lower respiratory tract infection (VLRTI), affecting infants <2 years of age. Respiratory syncytial virus (RSV) and rhinovirus (RV) are the predominant viruses, associated with severe VLRTI in infancy. Few prospective studies used an exercise provocation challenge, which is an indirect provocation test highly specific for asthma, to study the development of asthma in children with a history of VLRTI. These exercise challenge tests were not standardized and pulmonary function measurements were performed only 5, 10 and 15 minutes after exercise, which probably underestimates the prevalence of exercise induced bronchoconstriction (EIB) in these children. Main objective of this study is to investigate the prevalence of EIB in young children with a history of hospitalisation for VLRTI, using a newly designed exercise provocation challenge adjusted to the specific age-related course of EIB and to their age group.
- Main changes (audit trail)
- RECORD8-nov-2011 - 9-apr-2012


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