Condition category
Respiratory
Date applied
07/10/2009
Date assigned
08/12/2009
Last edited
17/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.generationr.nl/

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 measures

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

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

http://www.zonmw.nl/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Additional files

Editorial Notes