Determining the Impact of Air Pollution on the Developing Brain

NCT ID: NCT04574414

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2023-12-31

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.

Conditions

Attention Deficit Hyperactivity Disorder; Attention; Executive Functioning; Social Functioning

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Children with Attention Deficit Hyperactivity Disorder

Cases

Psychological testing and MRI imaging

Intervention Type: DIAGNOSTIC_TEST

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.

Children without Attention Deficit Hyperactivity Disorder

Population controls

Psychological testing and MRI imaging

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Environmental Protection - National Research Institute (IOS-PIB)

UNKNOWN

Sponsor Role: collaborator

Foundation for Polish Science

UNKNOWN

Sponsor Role: collaborator

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Marcin Szwed

Leader of the NeuroSmog consortium

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Psychology

Krakow, , Poland

Countries

Poland

Central Contacts

Marcin Szwed, Dr. hab.

Role: CONTACT

m.szwed@uj.edu.pl

12 663 24 40 ext. +48

Iana Markevych, PhD

Role: CONTACT

iana.markevych@uj.edu.pl

References

Compa M, Walczak B, Baumbach C, Kolodziejczyk J, Mysak Y, Lipowska M, Izydorczyk B, Sitnik-Warchulska K, Markevych I, Szwed M. Association of Socioeconomic Status With IQ and Attention in School Children in Poland, a Country With Relatively Low Socioeconomic Differences. Dev Psychobiol. 2025 Jul;67(4):e70058. doi: 10.1002/dev.70058.

Reference Type: DERIVED

PMID: 40534211 (View on PubMed)

Other Identifiers

KE_24042019A

Identifier Type: -

Identifier Source: org_study_id