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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05368493
Enrollment
182
Registered
2022-05-10
Start date
2023-01-23
Completion date
2028-06-01
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodevelopmental Disorders, Pollution; Exposure

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.

Interventions

OTHERMRI 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.

Sponsors

New York State Psychiatric Institute
Lead SponsorOTHER
University of Puerto Rico
CollaboratorOTHER
National Institute of Environmental Health Sciences (NIEHS)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 11 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Frontal lobe and corpus callosum volumesChildren 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.

Countries

Puerto Rico, United States

Contacts

PRINCIPAL_INVESTIGATORClaudia I Lugo-Candelas, PhD

Columbia University Irving Medical Center/New York State Psychiatric institute

PRINCIPAL_INVESTIGATORLigia Chavez, PhD

University of Puerto Rico

PRINCIPAL_INVESTIGATORCristiane S Duarte, PhD

Columbia University Irving Medical Center/New York State Psychiatric institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026