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KOALA Birth Cohort Study: home-visits at age 6-8 years.

KOALA Birth Cohort Study: home-visits at age 6-8 years. - KOALA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31560
Enrollment
4794
Registered
2008-07-14
Start date
2008-11-25
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overgewicht/obesitas allergy/asthma and overweight/obesity

Interventions

Although the study design is an observational cohort study, the administration of salbutamol to measure reversibility of bronchial obstruction can be seen as a non-therapeutic intervention. During t

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the 6-8 years follow-up is active membership of the cohort, i.e. all cohort members who have not indicated that they wanted to stop cooperation with further follow-up at the previous occasions when they were asked for informed consent, or on other occasions on their own initiative.

Exclusion criteria

Exclusion criteria: At baseline children with congenital diseases and children born prematurely (

Design outcomes

Primary

MeasureTime frame
During this follow-up main study parameters of allergic diseases will be parentally reported symptoms as assessed by validated questionnaires in the whole study population. Phenotypes of asthma are measured in the child (NO in exhaled air, lung function as assessed by spirometry (baseline and if below a certain thresshold, reversibility of obstruction by response to a bronchodilator), eczema as diagnosed by a trained nurse, in a part of the cohort (n = 1598). Phenotypes of overweight, obesity and related parameters are measured (weight, height, waist circumference, skinfold thickness, blood pressure, body fat composition by bioelectric impedance analysis). Furthermore, the following biosamples will be taken from the child and biobanked: a new faecal sample (to determine the microbial composition); exhaled breath condensate (for future measurement of inflammation markers) and finger prick blood (for measurement of specific IgE against common food and airway allergens, and for future measurement of metabolic parameters). During this period blood pressure measurement will be done twice daily by the parents, using the Omron device for self-measurement. Baseline lung function tests and body composition will also be measured in mothers, as well as blood pressure measurements in both parents. These data will be used as a measure for the child's constitution and shared environment. A subgroup of children will be invited to the hospital (In case of any doubt on the diagnosis of asthma as obtained by the lung function testing during the home-visit combined with reported symptoms). At the hospital a histamine provocation test will be performed to elucidate wether the child has asthma or not (see figures 1 and 2).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)