Determining the Impact of Air Pollution on the Developing Brain

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Attention
Attention Deficit Disorder with Hyperactivity
Attention Deficit Hyperactivity Disorder
Executive Functioning
Social Functioning

Clinical Trial Details

NCT number	NCT04574414
Study type	Observational
Source	Jagiellonian University
Contact	Marcin Szwed, Dr. hab.
Phone	12 663 24 40
Email	m.szwed@uj.edu.pl
Status	Not yet recruiting
Phase
Start date	October 1, 2020
Completion date	December 31, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Determining the Impact of Air Pollution on the Developing Brain — NeuroSmog

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms