Early detection of asthma-like symptoms in pre-school children at preventive Child Health Centres in the Netherlands

ISRCTN	ISRCTN15790308
DOI	https://doi.org/10.1186/ISRCTN15790308
Protocol serial number	22000128
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Submission date: 07/10/2009
Registration date: 08/12/2009
Last edited: 17/03/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hein Raat
Scientific

Erasmus MC University Medical Centre Rotterdam
Department of Public Health
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 70 44095
Email	h.raat@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled multicentre interventional trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Medical Ethics Research Committee of Erasmus Medical Centre, University Medical Centre Rotterdam, approved on the 9th January 2003 (ref: MEC 217.595/2002/202)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/03/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	14 Months
Upper age limit	45 Months
Sex	All
Target sample size at registration	6650
Key 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.
Key exclusion criteria	Children not participating the Generation R study who visit the 16 participating Child Health Centres in Rotterdam.
Date of first enrolment	01/07/2002
Date of final enrolment	31/03/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus MC University Medical Centre Rotterdam

Rotterdam
3000 CA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	reliability and validity of the Child Health Questionnaire short form results	01/01/2005		Yes	No
Results article	reliability and validity of health status measurements results	01/04/2005		Yes	No
Results article	preliminary results	01/10/2005		Yes	No
Results article	health-related quality of life results	01/10/2006		Yes	No
Results article	reliability and validity of the Infant and Toddler Quality of Life Questionnaire results	01/04/2007		Yes	No
Results article	results	13/03/2014		Yes	No
Protocol article	protocol	15/09/2010		Yes	No
Other publications	questionnaire construct validity	01/02/2005		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes