Who are we?


Signup for

Online registration

Log in to register
your trial

Search a trial




van CCT (UK)

van CCT (UK)

Prevention of passive smoking exposure in children with a high risk of asthma.

- candidate number8715
- NTR NumberNTR2632
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-nov-2010
- Secondary IDsNL 26349.068.09 / 09-2-019 ; CCMO / METC MUMC
- Public TitlePrevention of passive smoking exposure in children with a high risk of asthma.
- Scientific TitlePrevention of passive smoking exposure in children with a high risk of asthma: The results of an individualized, tailored intervention.
- hypothesisAn effective intervention towards stopping passive smoke exposure in children is possible by means of an individualized program with repeated counseling, education, motivational interviewing, and by promoting parental awareness with feedback about the lung function of the children and their urine cotinine levels.
- Healt Condition(s) or Problem(s) studiedSmoking cessation, Parents, Parents stopping
- Inclusion criteriaChildren aged 0-13 years with passive smoke exposure at home and high risk of asthma (asthma in the first degree).
- Exclusion criteria1. Children who are currently smoking themselves;
2. Parents already receiving professional help for smoking cessation;
3. Children with diagnosis of: Asthma, congenital malformations of the airways or other chronic lung diseases like CF or BPD, mental retardation or syndromes, heart disease.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate1-mrt-2013
- Target number of participants200
- InterventionsTwo hundred families (1child per family) are randomized into two groups: a control group, and an active intervention group. Stratification for ‘age’ will occur. The control group receives ‘usual care’ with no extra visits or extra information about health effects of smoking, other than standard usual care according to the standards of the Dutch Society of General Practitioners (NHG). The active intervention group receives an intervention strategy given by two trained practice nurses at home. The intervention consists of 6 counseling sessions during six months, each lasting about 1hour. The intervention consists of motivational interviewing and feedback on the children’s' lung function and urine cotinine measurements.
- Primary outcomePrimary outcome measure is the percentage of families with passive smoking cessation in children (measured via urine cotinine levels of the children and parental self-reports). Stopping passive smoking exposure at home is defined as the cessation of passive smoke exposure to children for at least 6 months after quit date. This can be achieved by parents smoking outside the house, by stopping active smoking or less ideal, smoking in a room where the child does not come.
- Secondary outcomeSecondary outcome measures are respiratory complaints and infections, nicotine levels at home, quality of life and lung function of the children.
- TimepointsLung function and cotinine measurements will be done at time points 0, 3, 6, 9 and 12 months.
The intervention group will receive the intervention during 6 months; from time point 1 month until 6 months.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Maastricht University Medical Center (MUMC+), Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
The Netherlands Asthma Foundation
- PublicationsN/A
- Brief summaryExposure to passive smoking is a huge problem world-wide. The WHO estimates that about 50% of children are exposed to passive smoking globally. The health effects of passive smoking in children are huge: on average, they have 30-40% more respiratory infections, a higher chance on asthma-like symptoms and more severe asthma, more episodes of acute bronchitis, a two times higher risk on ‘Sudden Infant Death syndrome (SIDS)’, and even more meningococcal septic shock syndrome. From earlier studies in the Netherlands (PIAMA, PREVASC, RAKKER) it is evident that even 30% of children at high risk for asthma are exposed to passive smoking. We recently found that children aged 0-2 years with a first degree family member with asthma and passive smoke exposure had a 6 to 7 times higher risk on ‘wheezing ever’ or ‘attacks of wheezing’ than children without asthma in the first degree. This underlines the importance of effective prevention of passive smoking at home in this group of vulnerable children. The purpose of this study is to test the effectiveness of a new intervention. The intervention is an individualized, subject-tailored program with repeated contacts, including motivational interviewing, attention for barriers and needs of parents, and feedback on the children’s urine cotinine levels and lung functions. Such an innovative approach is a further development of existing knowledge in the literature and has a high chance on being effective.
- Main changes (audit trail)
- RECORD29-nov-2010 - 15-dec-2010

  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar