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
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