Air Pollution and Development in the Boricua Youth Study

Not Applicable

• Conditions: Pollution; Exposure; Neurodevelopmental Disorders
• Interventions: Other: MRI task

• Registration Number: NCT05368493
• Lead Sponsor: New York State Psychiatric Institute

Brief 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.

Study Timeline

• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-10
• Study Start: 2023-01-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	MRI task	All participants will be in the same arm.

Primary Outcome Measures

Name	Time	Method
Frontal lobe and corpus callosum volumes	Children will be scanned either at 6-36 months or 6-11 years of age, depending on when the participants are enrolled.	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.

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States