Prevention of asthma in children at high risk of developing asthma

ISRCTN	ISRCTN66748327
DOI	https://doi.org/10.1186/ISRCTN66748327
Secondary identifying numbers	NTR371

Submission date: 19/12/2005
Registration date: 19/12/2005
Last edited: 13/11/2008

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof C P van Schayck
Scientific

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

Study information

Study design	Multicentre, randomised, single-blind, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Scientific title	Prevention of asthma in children at high risk of developing asthma by advising parents on reducing environmental exposures
Study acronym	PREVASC-OMEGA
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/1997
Completion date	01/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	443
Key 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
Key exclusion criteria	1. Major language problem 2. Intrauterine or neonatal death 3. Moving outside the Netherlands 4. Severe illness/malformation child
Date of first enrolment	01/01/1997
Date of final enrolment	01/07/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

University Maastricht (UM)

Maastricht
6200 MD
Netherlands

Sponsor information

University Maastricht (UM) (The Netherlands)
University/education

P.O. Box 616
Maastricht
6200 MD
Netherlands

"ROR"	https://ror.org/02jz4aj89

Funders

Funder type

Research organisation

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

No information available

Netherlands Asthma Foundation (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan