Main objective of this study is to investigate the prevalence of EIB in young children with a history of hospitalisation for VLRTI, using an exercise provocation challenge adjusted to the specific age-related course of EIB.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary 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 (FEV0.5) during and post-exercise in young
children, hospitalised in infancy with VLRTI.
Secondary outcome
Secondary objectives are:
-The percent change in other pulmonary function parameters (FEV1, FEF50) during
and post-exercise in young children, hospitalised in infancy with VLRTI.
-To compare the prevalence of EIB in young children with a history of VLRTI
caused by different pathogens (RSV versus RV)
-The analysis of anthropometric measures, clinical features, medication use and
(microbiologic) history of young children with a history of hospitalisation for
VLRTI
-To 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; in the
Netherlands between 5-10% in children aged 4-12).
Background summary
Hospitalisation 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 have examined the development of asthma in
children with a history of VLRTI by using an exercise provocation challenge,
which is an indirect provocation test highly specific for asthma. 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.
Study objective
Main objective of this study is to investigate the prevalence of EIB in young
children with a history of hospitalisation for VLRTI, using an exercise
provocation challenge adjusted to the specific age-related course of EIB.
Study design
This study is a prospective cohort study.
Patients will undergo an extensive evaluation of their asthma, including a
history, physical examination and an 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). Exercise induced
bronchoconstriction is defined as a >13% fall in FEV0.5 after exercise. If
bronchoconstriction persists 15 minutes post-exercise (i.e. FEV0.5 less than
95% from baseline value) or at childrens request, 100 µg salbutamol will be
administered and a flow volume loop will be repeated 5 minutes after salbutamol
to establish recovery.
The exercise provocation challenge takes place in the skating rink, because the
air condition (cold and dry) is standardized and reflects the mean air
condition in Holland (*real life test*). Moreover, an exercise challenge in dry
air is a more sensitive test to diagnose exercise induced bronchoconstriction.
Children with a negative exercise provocation challenge will be invited to a
second challenge on another day, to prevent false negative results.
Intervention
The intervention is an exercise provocation challenge. This exercise 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).
The exercise provocation challenge takes place in the skating rink, because the
air condition (cold and dry) is standardized and reflects the mean air
condition in Holland (*real life test*). Moreover, an exercise challenge in dry
air is a more sensitive test to diagnose exercise induced bronchoconstriction.
Children are involved in all kinds of exercise all day long and for children,
exercise is a way of recreation. Our exercise challenge (jumping on a jumping
castle) was especially designed for young children and is a child-friendly and
safe way of exercise. Experience from previous research (a pilot study and
study NL38021.044.11) with the same exercise challenge has learned us that
children enjoy performing the test. For these reasons we believe that our
intervention is not harmful to the children.
Study burden and risks
The risks of participation are considered minimal.
Patients have to undergo an exercise provocation challenge with the chance of
getting dyspnoeic. Especially in children, exercise limitation is a heavy
burden on the quality of life, however the exercise challenges alone pose a
minimal risk. The possible dyspnoea is comparable to that experienced when
exercising in real life and children generally consider this as a minimal
burden. When indicated (i.e. if bronchoconstriction persists 15 minutes after
exercsie or at patients request) salbutamol will be administered. If children
become dyspnoeic during exercise, exercise will be terminated. With the
development of the design of our exercise provocation challenge, the age of the
children is taken into consideration. We tried to minimize the burden of
exercise by using a jumping castle. Experience from previous research (a pilot
study and study NL38021.044.11) with the same exercise challenge has learned us
that children enjoy performing the test. For these reasons we believe that our
intervention is not harmful to the children.The benefit is that patients (and
parents) get an evaluation of the extent of their asthma. This study must be
performed in this young patient group, because diagnosing asthma at this age
enables early therapeutic intervention, thereby preventing long term
remodelling of the asthmatic airways. Moreover, we would like to compare our
results with the scarce existing data,in this age group.
Haaksbergerstraat 55
7513 ER Enschede
NL
Haaksbergerstraat 55
7513 ER Enschede
NL
Listed location countries
Age
Inclusion criteria
- History of hospitalisation for viral lower respiratory tract infection (VLRTI) <2 years of age (subjects will be recruited from VLRTI cohort)
- Age 5 through 7 years
- Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%
- Clinically stable period at least 4 weeks before the study period (no hospital admission or
use of systemic corticosteroids)
Exclusion criteria
-Use of systemic corticosteroids in the last 4 weeks prior to the study
-Use of long acting bronchodilators 24 hours before testing
-Use of short acting bronchodilators 8 hours before testing
-Use of leukotriene antagonists 24 hours before testing
-Comorbidity (other pulmonary or cardiac disorder, mental retardation/motor dysfunction)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL38731.000.12 |
Other | NTR nr volgt |
OMON | NL-OMON24718 |