Condition category
Respiratory
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
13/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof C P van Schayck

ORCID ID

Contact details

University Maastricht (UM)
CAPHRI Research Institute
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR371

Study information

Scientific title

Prevention of asthma in children at high risk of developing asthma by advising parents on reducing environmental exposures

Acronym

PREVASC-OMEGA

Study hypothesis

Children in the intervention group will show to have less asthma symptoms and a better lung function than children in the control group as measured at age 6 years by questionnaire (symptoms), general practitioners registration (symptoms), and lung function measurements (microRint, FEHO, forced expiratory volume in one second (FEV1), PC20, reversibility).

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised, single-blind, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Asthma

Intervention

Advisory intervention on reducing exposure to:
1. Allergen exposure (house dust mite, cat and dog allergens)
2. Food allergens by exclusively breastfeeding for a period of 6 months or if not possible feeding the child with hypo-allergenic formula, introducing solids until 6 months
3. Environmental tobacco smoke (parents stop smoking)
Control group: usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Current asthma 6 years as measured in lung function laboratory combined with asthma complaints as registered by General Practitioner and/or parents (questionnaires).

Secondary outcome measures

1. Asthma diagnosis by General Practitioner
2. Asthma symptoms 0 - 6 years (questionnaires)
3. Asthma symptoms 0 - 6 years (General Practitioner)
4. Hospital admission for asthma symptoms
5. Allergy (as registered by parents, general practitioner, IgE measurements project)

Overall trial start date

01/01/1997

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

General practitioners, midwives and gynaecologists were instructed to check the inclusion criteria:
1. Pregnant women less than 7 months gestational age
2. Unborn child at high risk of developing asthma on grounds of familial predisposition first degree
3. Living in study region

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

443

Participant exclusion criteria

1. Major language problem
2. Intrauterine or neonatal death
3. Moving outside the Netherlands
4. Severe illness/malformation child

Recruitment start date

01/01/1997

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Maastricht (UM)
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

University Maastricht (UM) (The Netherlands)

Sponsor details

P.O. Box 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Asthma Foundation (The 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

Publication citations

Additional files

Editorial Notes