|- candidate number||6317|
|- NTR Number||NTR1955|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-aug-2009|
|- Secondary IDs||3.4.08.019 Dutch Astma Foundation|
|- Public Title||Detection of early signs of astma in children with airway problems.|
|- Scientific Title||Confirmed wheezing in infancy as basis for molecular fingerprinting in the prediction of asthma.|
|- ACRONYM||EUROPA - Early Unbiased Risk-Assesment of Pediatric Astma|
|- hypothesis||We postulate that the development of asthma in preschool children can be captured during the first 2 years of life by a minimally invasive ‘fingerprint’.|
|- Healt Condition(s) or Problem(s) studied||Respiratory distress|
|- Inclusion criteria||All children aged under 18 months will be included in the cohort.|
|- Exclusion criteria||Age over 18 months.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||9-jan-2009|
|- planned closingdate||9-jan-2015|
|- Target number of participants||1000|
|- Interventions||None, the study is purely observational.|
|- Primary outcome||Astma as determined by bronchial hyperreactivity testing at age 6.|
|- Secondary outcome||N/A|
|- Timepoints||Asthma at age 6.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc Marc P.C. Schee, van der|
|- CONTACT for SCIENTIFIC QUERIES||MSc Marc P.C. Schee, van der|
|- Sponsor/Initiator ||Netherlands Asthma Foundation|
(Source(s) of Monetary or Material Support)
|Netherlands Asthma Foundation|
|- Brief summary||Study synopsis:|
Confirmed wheezing in infancy as basis for molecular fingerprinting in the prediction of asthma. EuroPA study.
Young children with confirmed wheeze do already exhibit the major histological features of asthma. There is increasing evidence that microbial and biological characteristics can improve the phenotyping of infants at risk of asthma. The aim of the present study is to use confirmed wheezing as the basis for the application of modern molecular profiling in the prediction of asthma in young children.
We postulate that the development of asthma in preschool children can be captured during the first 2 years of life by a minimally invasive ‘fingerprint’.
Patients - 1000 infants (< 2 years):
1. 330 patients will present with parent reported wheeze of which 130 will exhibit confirmed wheeze;
2. 100 aged matched infants will be used as controls from the same cohort.
3-phase 6 years prospective follow-up study:
1. Phase 1 (2 yrs duration): inclusion and baseline assessments in wheezy infants and their healthy age-matched controls during the first 2 years of life;
2. Phase 2 (2 yrs duration): monitoring of respiratory symptoms;
3. Phase 3 (2 yrs duration): outcome assessment of the children for the presence of objective criteria for asthma at age 5.
Asthma at the age of 5 years, objectively established on basis of a validated combination of symptoms and/or the use of asthma medication, in combination with spirometry and increased bronchial hyper responsiveness, based upon the then applicable international standards.
Predictors will be gathered by means of:
1. Wheeze confirmation;
2. Exhaled air: Molecular pattern recognition by electronic nose;
3. Nasal aspirate and throat swab: Viral and typical/atypical bacterial detection by qPCR;
4. Molecular phenotyping: Quantitative PCR analysis, cellular and soluble immunological
markers, and multiplex antibody measurements in whole venous blood samples.
Associations between predictors and outcome will be examined by univariate analysis and predictive logistic models.
The concept of confirmed wheezing can be considered as a new clinical opportunity to provide phenotype-specific management in preschool children. By combining this with molecular profiling, our study aims to provide a clinical-molecular signature for the prediction of asthma. We hope that this can be applied for the development of focused treatment and prevention.
|- Main changes (audit trail)|
|- RECORD||13-aug-2009 - 11-okt-2009|