Clinical trial NCT05368493: Air Pollution and Development in the Boricua Youth Study
Official title: Prenatal Air Pollution and Neurodevelopment: a Longitudinal Neuroimaging Study of Mechanisms and Early Risk for ADHD in Puerto Rican Children
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pollution; Exposure
Neurodevelopmental Disorders
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: University of Puerto Rico
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2022-05-10
Enrollment: 182
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frontal lobe and corpus callosum volumes
timeFrame: Children will be scanned either at 6-36 months or 6-11 years of age, depending on when the participants are enrolled.
Secondary outcomes:
Other outcomes:
measure: Exploratory- Task fMRI (Simon)
timeFrame: Children will undergo MRI scans when they are 6-11 years of age.
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University Irving Medical Center/New York State Psychiatric institute
name: Claudia I Lugo-Candelas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Puerto Rico
name: Glorisa Canino, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University Irving Medical Center/New York State Psychiatric institute
name: Cristiane S Duarte, PhD
role: PRINCIPAL_INVESTIGATOR
References: