Air Pollution and Development in the Boricua Youth Study

Neurodevelopmental Disorders Clinical Trial

Official title:

Prenatal Air Pollution and Neurodevelopment: a Longitudinal Neuroimaging Study of Mechanisms and Early Risk for ADHD in Puerto Rican Children

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05368493
• Other study ID #: 8232
• Secondary ID: R01ES032870-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to understand the relationship between prenatal maternal air pollution exposure and offspring risk for ADHD and examine two potential -modifiable- mechanisms: prenatal maternal inflammation and offspring sleep problems. We will employ a longitudinal neuroimaging study design and leverage a well-characterized intergenerational cohort of Puerto Ricans to address prior literature's limitations. This will be the first study to use infant neuroimaging to disassociate the effects of prenatal pollution exposure from those of postnatal pollution exposure, adversity and disadvantage, and offspring genetic risk for ADHD.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 182
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 11 Years

Eligibility

Inclusion Criteria:

• Having been enrolled in the BYS-ECHO birth cohort (parent study).

• Speaks English or Spanish.

• Having a parent that is eligible to participate, based on criterial detailed below, and agrees to participation.

• One parent must speak English or Spanish.

Exclusion Criteria:

• Having serious neurological disorder, excluding ASD (e.g., seizure disorder).

• MRI contraindications (irremovable metal in body like braces, pacemakers).

• Claustrophobia.

• Having a parent that is not competent to consent (e.g., severe intellectual disability would have triggered exclusion) or under 18 years of age.

Related Conditions & MeSH terms

• Neurodevelopmental Disorders
• Pollution; Exposure

Intervention

Other:
• MRI task
Task fMRI (Simon) [ Time Frame: Children will undergo MRI scans when they are 6-11 years of age. ] Children will also complete a task, which will allow exploratory analyses of the functionality of attention-related neural circuits. The Simon fMRI task is a non-verbal task equivalent to the Stroop that tests sustained attention and inhibitory control and discriminates children with and without ADHD. Exploratory fMRI time-series data for each participant will be modeled using a general linear model with 3 predictors: congruent correct, incongruent correct, and incorrect. Contrast images for each participant (e.g., incongruent-minus-congruent) will be generated and entered into a group-level random-effects model. Analyses are exploratory, and will focus on frontal lobe activity during each type of trial.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Environmental Health Sciences (NIEHS), University of Puerto Rico

Country where clinical trial is conducted

United States, 

References & Publications (2)

Myhre O, Lag M, Villanger GD, Oftedal B, Ovrevik J, Holme JA, Aase H, Paulsen RE, Bal-Price A, Dirven H. Early life exposure to air pollution particulate matter (PM) as risk factor for attention deficit/hyperactivity disorder (ADHD): Need for novel strategies for mechanisms and causalities. Toxicol Appl Pharmacol. 2018 Sep 1;354:196-214. doi: 10.1016/j.taap.2018.03.015. Epub 2018 Mar 14. — View Citation

Perera FP, Tang D, Wang S, Vishnevetsky J, Zhang B, Diaz D, Camann D, Rauh V. Prenatal polycyclic aromatic hydrocarbon (PAH) exposure and child behavior at age 6-7 years. Environ Health Perspect. 2012 Jun;120(6):921-6. doi: 10.1289/ehp.1104315. Epub 2012 Mar 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory- Task fMRI (Simon)	Children will also complete a task, which will allow exploratory analyses of the functionality of attention-related neural circuits. The Simon fMRI task is a non-verbal task equivalent to the Stroop that tests sustained attention and inhibitory control and discriminates children with and without ADHD. Exploratory fMRI time-series data for each participant will be modeled using a general linear model with 3 predictors: congruent correct, incongruent correct, and incorrect. Contrast images for each participant (e.g., incongruent-minus-congruent) will be generated and entered into a group-level random-effects model. Analyses are exploratory, and will focus on frontal lobe activity during each type of trial.	Children will undergo MRI scans when they are 6-11 years of age.
Primary	Frontal lobe and corpus callosum volumes	Frontal lobe and corpus callosum volumes in will be measure in offspring. Bilateral middle frontal cortex and corpus callosum volumes will be used in hypothesis testing.	Children will be scanned either at 6-36 months or 6-11 years of age, depending on when the participants are enrolled.