Prenatal Air Pollution and Neurodevelopment: a Longitudinal Neuroimaging Study of Mechanisms and Early Risk for ADHD in Puerto Rican Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 182
- Locations
- 2
- Primary Endpoint
- Frontal lobe and corpus callosum volumes
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 11 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
All participants
All participants will be in the same arm.
Intervention: MRI task (Other)
Outcomes
Primary Outcomes
Frontal lobe and corpus callosum volumes
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Claudia Lugo-Candelas
Assistant Professor
New York State Psychiatric Institute