Trials / Unknown
UnknownNCT04574414
Determining the Impact of Air Pollution on the Developing Brain
NeuroSmog: Determining the Impact of Air Pollution on the Developing Brain
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 800 (estimated)
- Sponsor
- Jagiellonian University · Academic / Other
- Sex
- All
- Age
- 10 Years – 13 Years
- Healthy volunteers
- Not accepted
Summary
* Background: Recent studies have linked exposure to airborne particulate matter (PM) to neurodevelopmental outcomes but the findings are mixed and mechanisms are unclear. We aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution. The investigators aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution. * Study area: 19 towns in three voivodeships (Lesser Poland, Silesian, Opole) in the southern Poland. To reduce confounding by urbanicity and at the same time, to achieve sufficient contrasts in PM levels without too high logistic costs, towns were selected by size (big and small) and by PM levels (high, medium and low). * Design: Case-control study with 800 children recruited over two school years, with two population controls per one ADHD case. Suspected cases will be recruited in specialized facilities and presumably ADHD-free children will be recruited in primary schools. * Exposure assessment: Poland-wide PM and other air pollutants' grids will be created for the years 2006 to 2021 using statistical models to incorporate land use data, estimates from transport models, satellite observations and air pollution measurements from Polish monitoring network. Prenatal, early-life, lifelong and concurrent exposures will be calculated. * Psychological testing: Every child and their parents will complete a series of psychological tests and interviews that will be conducted during their three visits to the recruitment facility. * Neuroimaging: Each participant will undergo a Magnetic Resonance Imaging (MRI) scanning session that will be performed accordingly to the Human Connectome Adolescent Brain Cognitive Development project recommendations. Scanning will be performed on a single scanner in Krakow.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Psychological testing and MRI imaging | Every child will have three sessions with psychologists and be diagnosed as having or not having ADHD. Every child will be invited to Krakow to undergo MRI measurements, including resting-state and event-related functional MRI, Diffusion Tensor Imaging (DTI), and T1/T2 structural MRI. |
Timeline
- Start date
- 2020-10-01
- Primary completion
- 2022-12-31
- Completion
- 2023-12-31
- First posted
- 2020-10-05
- Last updated
- 2020-10-05
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT04574414. Inclusion in this directory is not an endorsement.