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NCT05368493 | Enrolling by invitation | Pollution; Exposure

Air Pollution and Development in the Boricua Youth Study
Sponsor:

New York State Psychiatric Institute

Information provided by (Responsible Party):

Claudia Lugo-Candelas

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.

Condition or disease

Pollution; Exposure

Neurodevelopmental Disorders

Intervention/treatment

MRI task

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 182 participants
Masking : None (Open Label)
Primary Purpose : Basic Science
Official Title : Prenatal Air Pollution and Neurodevelopment: a Longitudinal Neuroimaging Study of Mechanisms and Early Risk for ADHD in Puerto Rican Children
Actual Study Start Date : January 23, 2023
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : June 2027
Arm Intervention/treatment

Other: All participants

All participants will be in the same arm.

Other: MRI task
Ages Eligible for Study: 6 Months to 11 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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.
Air Pollution and Development in the Boricua Youth Study

Location Details

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Air Pollution and Development in the Boricua Youth Study

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Locations

Not yet recruiting

United States, New York

New York State Psychiatric Institute

New York, New York, United States, 10032