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Air Pollution and Development in the Boricua Youth Study

N

New York State Psychiatric Institute

Status

Invitation-only

Conditions

Pollution; Exposure
Neurodevelopmental Disorders

Treatments

Other: MRI task

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05368493
8232
R01ES032870-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

182 estimated patients

Sex

All

Ages

6 months to 11 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

182 participants in 1 patient group

All participants
Other group
Description:
All participants will be in the same arm.
Treatment:
Other: MRI task

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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