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

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN15790308
• Date of registration: 08/12/2009
• Primary sponsor: The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
• Public title: Early detection of asthma-like symptoms in pre-school children at preventive Child Health Centres in the Netherlands N/A
• 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
• Date of first enrolment: Jul 1 2002
• Target sample size: 6650 children
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN15790308
• Study type: Interventional
• Study design: Randomised controlled multicentre interventional trial

Countries of recruitment

Netherlands

Contacts

• Name: Hein Raat

Key inclusion & exclusion criteria

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.
Exclusion criteria: Children not participating the Generation R study who visit the 16 participating Child Health Centres in Rotterdam.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Asthma-like symptoms

Intervention(s)

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.

Primary Outcome(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.

Secondary Outcome(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.

Secondary ID(s)

22000128

Source(s) of Monetary Support

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Secondary Sponsor(s)

N/A