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Air Pollution and Development in the Boricua Youth Study

Primary Purpose

Pollution; Exposure, Neurodevelopmental Disorders

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI task
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pollution; Exposure

Eligibility Criteria

6 Months - 11 Years (Child)All SexesAccepts 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.

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All participants

Arm Description

All participants will be in the same arm.

Outcomes

Primary Outcome Measures

Frontal lobe and corpus callosum volumes
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 Outcome Measures

Full Information

First Posted
May 5, 2022
Last Updated
April 11, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
University of Puerto Rico, National Institute of Environmental Health Sciences (NIEHS)
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1. Study Identification

Unique Protocol Identification Number
NCT05368493
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
University of Puerto Rico, National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pollution; Exposure, Neurodevelopmental Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All participants
Arm Type
Other
Arm Description
All participants will be in the same arm.
Intervention Type
Other
Intervention Name(s)
MRI task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frontal lobe and corpus callosum volumes
Description
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.
Time Frame
Children will be scanned either at 6-36 months or 6-11 years of age, depending on when the participants are enrolled.
Other Pre-specified Outcome Measures:
Title
Exploratory- Task fMRI (Simon)
Description
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.
Time Frame
Children will undergo MRI scans when they are 6-11 years of age.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia I Lugo-Candelas, PhD
Organizational Affiliation
Columbia University Irving Medical Center/New York State Psychiatric institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Glorisa Canino, PhD
Organizational Affiliation
University of Puerto Rico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristiane S Duarte, PhD
Organizational Affiliation
Columbia University Irving Medical Center/New York State Psychiatric institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified participant level data will be shared as required by NIH's 2003 Data Sharing Policy. The data sharing plan and elements are still being determined.
Citations:
PubMed Identifier
29550511
Citation
Myhre O, Lag M, Villanger GD, Oftedal B, Ovrevik J, Holme JA, Aase H, Paulsen RE, Bal-Price A, Dirven H. Early life exposure to air pollution particulate matter (PM) as risk factor for attention deficit/hyperactivity disorder (ADHD): Need for novel strategies for mechanisms and causalities. Toxicol Appl Pharmacol. 2018 Sep 1;354:196-214. doi: 10.1016/j.taap.2018.03.015. Epub 2018 Mar 14.
Results Reference
background
PubMed Identifier
22440811
Citation
Perera FP, Tang D, Wang S, Vishnevetsky J, Zhang B, Diaz D, Camann D, Rauh V. Prenatal polycyclic aromatic hydrocarbon (PAH) exposure and child behavior at age 6-7 years. Environ Health Perspect. 2012 Jun;120(6):921-6. doi: 10.1289/ehp.1104315. Epub 2012 Mar 14.
Results Reference
background

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Air Pollution and Development in the Boricua Youth Study

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