NCT04574414UnknownNot Applicable
NeuroSmog: Determining the Impact of Air Pollution on the Developing Brain
Jagiellonian University1 site in 1 country800 target enrollmentStarted: October 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Cognitive functioning
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 10 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Attending school in one of the specified towns
- •Age 10-13 years (4th-6th grade)
- •Native Polish speaker
- •Normal or above intelligence
- •Standard educational opportunities
- •Normal or corrected to normal visual and auditory acuity
- •No gross sensory deficit, no gross behavioural problems
- •No history of neurological disease
Exclusion Criteria
- •Autism spectrum disorder (ASD)
- •Intellectual disability
- •Metabolic disorders
- •Genetic disorders
- •Cerebral palsy
- •Mood disorders
- •Tourette Syndrome
- •Other illnesses including pharmacotherapy
- •Apgar score < 8
- •Low birth weight (below 2500 g)
- •Preterm birth (below 35th weeks of gestation)
Outcomes
Primary Outcomes
Cognitive functioning
Time Frame: October 1, 2020 until December 31, 2022
Memory, attention, and executive functions measurement will be assessed by Diagnostic battery for cognitive functions evaluation (PU1)
Inhibition control
Time Frame: October 1, 2020 until December 31, 2022
Go/No Go task will be used as part of MRI measurements.
Attention Deficit Hyperactivity Disorder (ADHD)
Time Frame: October 1, 2020 until December 31, 2022
ADHD and comorbidities will be assessed by Conners 3 questionnaire
Attention control
Time Frame: October 1, 2020 until December 31, 2022
Attention Network Test (ANT) will be used.
Sustained and selective attention
Time Frame: October 1, 2020 until December 31, 2022
Computer Conners Continuous Performance Task (CPT) will be used.
Secondary Outcomes
- Full-Scale Intelligence Quotient (IQ)(October 1, 2020 until December 31, 2022)
- Family functioning(October 1, 2020 until December 31, 2022)
- Behavioural, emotional, and social problems(October 1, 2020 until December 31, 2022)
- Relationships with siblings(October 1, 2020 until December 31, 2022)
- Behavioural problems(October 1, 2020 until December 31, 2022)
Investigators
Marcin Szwed
Leader of the NeuroSmog consortium
Jagiellonian University
Study Sites (1)
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