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Determining the Impact of Air Pollution on the Developing Brain

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04574414
Acronym
NeuroSmog
Enrollment
800
Registered
2020-10-05
Start date
2020-10-01
Completion date
2023-12-31
Last updated
2020-10-05

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

Conditions

Attention, Attention Deficit Hyperactivity Disorder, Executive Functioning, Social Functioning

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.

Interventions

DIAGNOSTIC_TESTPsychological 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.

Sponsors

Institute of Environmental Protection - National Research Institute (IOS-PIB)
CollaboratorUNKNOWN
Foundation for Polish Science
CollaboratorUNKNOWN
Jagiellonian University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 13 Years
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) * FAS * FAE * Intellectual disability * Metabolic disorders * Genetic disorders * Epilepsy * 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)

Design outcomes

Primary

MeasureTime frameDescription
Inhibition controlOctober 1, 2020 until December 31, 2022Conditioned Approach Response Inhibition Task (CARIT) will be used as part of MRI measurements.
Attention Deficit Hyperactivity Disorder (ADHD)October 1, 2020 until December 31, 2022ADHD and comorbidities will be assessed by Conners 3 questionnaire
Cognitive functioningOctober 1, 2020 until December 31, 2022Memory, attention, and executive functions measurement will be assessed by Diagnostic battery for cognitive functions evaluation (PU1)
Attention controlOctober 1, 2020 until December 31, 2022Attention Network Test (ANT) will be used.
Sustained and selective attentionOctober 1, 2020 until December 31, 2022Computer Conners Continuous Performance Task (CPT) will be used.

Secondary

MeasureTime frameDescription
Full-Scale Intelligence Quotient (IQ)October 1, 2020 until December 31, 2022IQ will be measured by Stanford-Binet Intelligence Scales, 5th Edition (SB5).
Family functioningOctober 1, 2020 until December 31, 2022Polish adaptation of the FACES-IV (Flexibility and Cohesion Evaluation Scales; SOR) will be used to estimate social functioning of the children (family functioning).
Relationships with siblingsOctober 1, 2020 until December 31, 2022Siblings Relationship Questionnaire (KRR), which is a supplement for the SOR Scale will be used to assess social functioning of the children (relationships with siblings).
Behavioural, emotional, and social problemsOctober 1, 2020 until December 31, 2022Youth Self-Report Scale (YSR) will be used for this assessment.
Behavioural problemsOctober 1, 2020 until December 31, 2022Child Behaviour Checklist (CBCL) questionnaire will collect information on the eight syndrome domains: anxious/depressed, depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour, aggressive behaviour

Countries

Poland

Contacts

Primary ContactMarcin Szwed, Dr. hab.
m.szwed@uj.edu.pl12 663 24 40
Backup ContactIana Markevych, PhD
iana.markevych@uj.edu.pl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026