NCT05368493

Air Pollution and Development in the Boricua Youth Study

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 6 Months – 11 Years
• Healthy volunteers: Accepted

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.

Detailed description

The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.

Conditions

• Pollution; Exposure
• Neurodevelopmental Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-23
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2022-05-10
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States