Contact information
Type
Scientific
Primary contact
Dr Hein Raat
ORCID ID
Contact details
Erasmus MC University Medical Centre Rotterdam
Department of Public Health
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 70 44095
h.raat@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
22000128
Study information
Scientific title
A randomised controlled multicentre interventional trial of early detection of asthma-like symptoms in pre-school children at preventive Child Health Centres in the Netherlands
Acronym
Study hypothesis
This study has been set up to evaluate the effectiveness of early detection of asthma-like symptoms in pre-school children at the Child Health Centres. In the short-term the effectiveness will be studied by the frequency of asthma-like symptoms and health-related quality of life. In the long-term the effectiveness will be studied by the frequency of asthma-like symptoms and by the prevalence of doctor-diagnosed asthma.
Please note that this trial is embedded within the Generation-R study, a population-based prospective cohort study from foetal life until young adulthood.
Ethics approval
Medical Ethics Research Committee of Erasmus Medical Centre, University Medical Centre Rotterdam, approved on the 9th January 2003 (ref: MEC 217.595/2002/202)
Study design
Randomised controlled multicentre interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Asthma-like symptoms
Intervention
16 Child Health Centres in Rotterdam are participating. These Child Health Centres were first stratified for the socioeconomic status of their neighbourhood and then randomised into 8 intervention Child Health Centres, where early detection procedure will be applied, and 8 control Child Health Centres, where no early detection procedure will be done; just routine procedure will be enhanced.
The early detection questionnaire contains 4 questions, based on selected and adapted questions from the International Studies of Asthma and Allergies in Childhood: about frequency of asthma-like symptoms (wheezing, shortness of breath, dyspnoea) last month and last year, medical treatment last month and smoke exposure in direct environment. The physician interviews the parents during the preventive health check at the intervention Child Health Centre at age 14, 24, 36 and 45 months.
At the intervention CHC's, detected children will be managed effectively by non-pharmacological interventions:
1. Referral to the General Practitioner
2. Advice to visit the General Practitioner when asthma-like symptoms return
3. Referral to asthma-nurse
4. Advice: ventilation of the family house and avoidance of allergic/non-allergic triggers
5. Personal advice to prevent smoke exposure to the child
6. Hand out a flyer about the prevention of passive smoking
7. Hand out a flyer with information about asthma disease
At the non-intervention CHC's, detected children will be managed effectively by non-pharmacological interventions (health education: avoidance of a smoky environment, ventilation of the family house and avoidance of allergic/non-allergic triggers) and if necessary referral to the GP or asthma nurse.
Data collection to age 3 years is completed. In principle, data collection goes on till June 2010 and after that a follow-up of 12 months is planned.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Frequency of asthma-like symptoms-questionnaire (last 4 weeks/12 months): International study of asthma and allergies in childhood/prevention and incidence of asthma and mite allergy (ISAAC/PIAMA) (wheezing, snoring breath, shortness of breath or dyspnoea)
2. Generic health-related quality of life of the child (last 4 weeks): Health Utilities Index 2/3; Child Health Questionnaire-Infant/Toddler
Follow-up:
1. Multi-RAST/Phadiatop-test (blood samples by Generation R): as indicator of allergic sensitisation
2. Micro-Rint: lung function
3. Exhaled nitric oxide (NO): asthmatic airway inflammation
Timepoints of measurement:
Age 14 months: preventive health check (June 2003 - June 2007)
Age 24 months: preventive health check (June 2004 - June 2008)
Age 36 months: preventive health check (June 2005 - June 2009)
Age 45 months: preventive health check (June 2006 - June 2010)
Age 5 years: follow-up measurements (November 2008 - November 2012)
In the future, within Generation R, outcomes at older ages, even into adulthood, may be measured.
Secondary outcome measures
Doctor diagnosed asthma - (question to parent(s): has a doctor ever diagnosed asthma in your child?)
Data on covariates will be gathered via procedures within the Generation R study from pharmacists, general practitioners, hospitals and questionnaires from parents, given informed consent.
Overall trial start date
01/07/2002
Overall trial end date
31/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The Generation R cohort includes 9778 mothers and their children. Of the 9778 women who enrolled in pregnancy, 7893 children participated in the post-natal cohort. The study population of this trial consists of all 7893 children who will be invited for a preventive health check by the 16 participating Child Health Centres in Rotterdam at age 14, 24, 36 and 45 months.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
6650 children
Participant exclusion criteria
Children not participating the Generation R study who visit the 16 participating Child Health Centres in Rotterdam.
Recruitment start date
01/07/2002
Recruitment end date
31/03/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus MC University Medical Centre Rotterdam
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
Laan van Nieuw Oost Indië 334
Postbox 93 245
The Hague
2509 AE
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2005 questionnaire construct validity in http://www.ncbi.nlm.nih.gov/pubmed/15789960
2. 2005 preliminary results in http://www.ncbi.nlm.nih.gov/pubmed/16155780
3. 2005 reliability and validity of health status measurements results in http://www.ncbi.nlm.nih.gov/pubmed/15781921
4. 2005 reliability and validity of the Child Health Questionnaire short form results in http://www.ncbi.nlm.nih.gov/pubmed/15598731
5. 2006 reliability and validity of the Infant and Toddler Quality of Life Questionnaire results in http://www.ncbi.nlm.nih.gov/pubmed/17111231
6. 2006 health-related quality of life results in http://www.ncbi.nlm.nih.gov/pubmed/16871636
7. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20843313
8. 2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24626147
Publication citations
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Questionnaire construct validity
Raat H, Bueving HJ, de Jongste JC, Grol MH, Juniper EF, van der Wouden JC, Responsiveness, longitudinal- and cross-sectional construct validity of the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) in Dutch children with asthma., Qual Life Res, 2005, 14, 1, 265-272.
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Preliminary results
Mohangoo AD, Essink-Bot ML, Juniper EF, Moll HA, de Koning HJ, Raat H, Health-related quality of life in preschool children with wheezing and dyspnea: preliminary results from a random general population sample., Qual Life Res, 2005, 14, 8, 1931-1936, doi: 10.1007/s11136-005-4345-y.
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Reliability and validity of health status measurements results
Bunge EM, Essink-Bot ML, Kobussen MP, van Suijlekom-Smit LW, Moll HA, Raat H, Reliability and validity of health status measurement by the TAPQOL., Arch. Dis. Child., 2005, 90, 4, 351-358, doi: 10.1136/adc.2003.048645.
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Reliability and validity of the Child Health Questionnaire short form results
Raat H, Botterweck AM, Landgraf JM, Hoogeveen WC, Essink-Bot ML, Reliability and validity of the short form of the child health questionnaire for parents (CHQ-PF28) in large random school based and general population samples., J Epidemiol Community Health, 2005, 59, 1, 75-82, doi: 10.1136/jech.2003.012914.
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Reliability and validity of the Infant and Toddler Quality of Life Questionnaire results
Raat H, Landgraf JM, Oostenbrink R, Moll HA, Essink-Bot ML, Reliability and validity of the Infant and Toddler Quality of Life Questionnaire (ITQOL) in a general population and respiratory disease sample., Qual Life Res, 2007, 16, 3, 445-460, doi: 10.1007/s11136-006-9134-8.
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Protocol
Hafkamp-de Groen E, Mohangoo AD, de Jongste JC, van der Wouden JC, Moll HA, Jaddoe VW, Hofman A, de Koning HJ, Raat H, Early detection and counselling intervention of asthma symptoms in preschool children: study design of a cluster randomised controlled trial., BMC Public Health, 2010, 10, 555, doi: 10.1186/1471-2458-10-555.
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Results
Hafkamp-de Groen E, van der Valk RJ, Mohangoo AD, van der Wouden JC, Duijts L, Jaddoe VW, Hofman A, de Koning HJ, de Jongste JC, Raat H, Evaluation of systematic assessment of asthma-like symptoms and tobacco smoke exposure in early childhood by well-child professionals: a randomised trial., PLoS ONE, 2014, 9, 3, e90982, doi: 10.1371/journal.pone.0090982.
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Oostenbrink R, Jansingh-Piepers EM, Raat H, Nuijsink M, Landgraf JM, Essink-Bot ML, Moll HA, Health-related quality of life of pre-school children with wheezing illness., Pediatr. Pulmonol., 2006, 41, 10, 993-1000, doi: 10.1002/ppul.20486.