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

Sponsor
Jagiellonian University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04574414
Collaborator
Institute of Environmental Protection - National Research Institute (IOS-PIB) (Other), Foundation for Polish Science (Other)
800
1
39
20.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Psychological testing and MRI imaging

Study Design

Study Type:
Observational
Anticipated Enrollment :
800 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
NeuroSmog: Determining the Impact of Air Pollution on the Developing Brain
Anticipated Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Attention Deficit Hyperactivity Disorder (ADHD) [October 1, 2020 until December 31, 2022]

    ADHD and comorbidities will be assessed by Conners 3 questionnaire

  2. Cognitive functioning [October 1, 2020 until December 31, 2022]

    Memory, attention, and executive functions measurement will be assessed by Diagnostic battery for cognitive functions evaluation (PU1)

  3. Attention control [October 1, 2020 until December 31, 2022]

    Attention Network Test (ANT) will be used.

  4. Sustained and selective attention [October 1, 2020 until December 31, 2022]

    Computer Conners Continuous Performance Task (CPT) will be used.

  5. Inhibition control [October 1, 2020 until December 31, 2022]

    Conditioned Approach Response Inhibition Task (CARIT) will be used as part of MRI measurements.

  6. Inhibition control [October 1, 2020 until December 31, 2022]

    Go/No Go task will be used as part of MRI measurements.

Secondary Outcome Measures

  1. Full-Scale Intelligence Quotient (IQ) [October 1, 2020 until December 31, 2022]

    IQ will be measured by Stanford-Binet Intelligence Scales, 5th Edition (SB5).

  2. Family functioning [October 1, 2020 until December 31, 2022]

    Polish adaptation of the FACES-IV (Flexibility and Cohesion Evaluation Scales; SOR) will be used to estimate social functioning of the children (family functioning).

  3. Relationships with siblings [October 1, 2020 until December 31, 2022]

    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).

  4. Behavioural, emotional, and social problems [October 1, 2020 until December 31, 2022]

    Youth Self-Report Scale (YSR) will be used for this assessment.

  5. Behavioural problems [October 1, 2020 until December 31, 2022]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 13 Years
Sexes Eligible for Study:
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)

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Psychology Kraków Poland 30-060

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marcin Szwed, Leader of the NeuroSmog consortium, Jagiellonian University
ClinicalTrials.gov Identifier:
NCT04574414
Other Study ID Numbers:
  • KE_24042019A
First Posted:
Oct 5, 2020
Last Update Posted:
Oct 5, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2020