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

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

• 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 Overview

• Status: Not yet recruiting
• Conditions: Attention Deficit Hyperactivity Disorder; Attention; Executive Functioning; Social Functioning
• Intervention / Treatment: Diagnostic test: Psychological testing and MRI imaging

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Marcin Szwed, Dr. hab.; Phone Number: +48 12 663 24 40; Email: m.szwed@uj.edu.pl
• Study Contact Backup: Name: Iana Markevych, PhD; Email: iana.markevych@uj.edu.pl

Study Locations

• Poland
  • Kraków, Poland, 30-060
    • Institute of Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

800 children aged 10-13 will be sampled to the NeuroSmog study. Both ADHD cases and population controls will be enrolled, two control per case. Cases will be recruited in specialized facilities and controls will be randomly sampled in randomly selected 30 primary schools across 19 big and small towns in Lesser Poland, Silesian and Opole voivodeships in the southern Poland.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with Attention Deficit Hyperactivity Disorder; Cases	Diagnostic test: 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.
Children without Attention Deficit Hyperactivity Disorder; Population controls	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention Deficit Hyperactivity Disorder (ADHD)	ADHD and comorbidities will be assessed by Conners 3 questionnaire	October 1, 2020 until December 31, 2022
Cognitive functioning	Memory, attention, and executive functions measurement will be assessed by Diagnostic battery for cognitive functions evaluation (PU1)	October 1, 2020 until December 31, 2022
Attention control	Attention Network Test (ANT) will be used.	October 1, 2020 until December 31, 2022
Sustained and selective attention	Computer Conners Continuous Performance Task (CPT) will be used.	October 1, 2020 until December 31, 2022
Inhibition control	Conditioned Approach Response Inhibition Task (CARIT) will be used as part of MRI measurements.	October 1, 2020 until December 31, 2022
Inhibition control	Go/No Go task will be used as part of MRI measurements.	October 1, 2020 until December 31, 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full-Scale Intelligence Quotient (IQ)	IQ will be measured by Stanford-Binet Intelligence Scales, 5th Edition (SB5).	October 1, 2020 until December 31, 2022
Family functioning	Polish adaptation of the FACES-IV (Flexibility and Cohesion Evaluation Scales; SOR) will be used to estimate social functioning of the children (family functioning).	October 1, 2020 until December 31, 2022
Relationships with siblings	Siblings Relationship Questionnaire (KRR), which is a supplement for the SOR Scale will be used to assess social functioning of the children (relationships with siblings).	October 1, 2020 until December 31, 2022
Behavioural, emotional, and social problems	Youth Self-Report Scale (YSR) will be used for this assessment.	October 1, 2020 until December 31, 2022
Behavioural problems	Child 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	October 1, 2020 until December 31, 2022

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Collaborators: Institute of Environmental Protection - National Research Institute (IOS-PIB); Foundation for Polish Science

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (ACTUAL): October 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: KE_24042019A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No