Determining the Impact of Air Pollution on the Developing Brain (NeuroSmog)

Jagiellonian University

Status: Unknown

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

Treatments: Diagnostic Test: Psychological testing and MRI imaging

Study type: Observational

Funder types: Other

Identifiers

NCT04574414

KE_24042019A

Details and patient eligibility

About

• 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 10 to 13 years old

Volunteers: No Healthy Volunteers

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)

Trial design

800 participants in 2 patient groups

Children with Attention Deficit Hyperactivity Disorder

Description:

Cases

Treatment:

Diagnostic Test: Psychological testing and MRI imaging

Children without Attention Deficit Hyperactivity Disorder

Description:

Population controls

Treatment:

Diagnostic Test: Psychological testing and MRI imaging