Pollution; ExposureNCT05368493
Air Pollution and Development in the Boricua Youth Study
A study testing MRI task in people with Pollution; Exposure and Neurodevelopmental Disorders, run by New York State Psychiatric Institute at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pollution; Exposure, Neurodevelopmental Disorders
- What is being tested?
- MRI task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Jan 2023to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Prenatal Air Pollution and Neurodevelopment: a Longitudinal Neuroimaging Study of Mechanisms and Early Risk for ADHD in Puerto Rican Children
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.
Read the 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.
- Conditions
- Pollution; Exposure, Neurodevelopmental Disorders
- Being tested
- MRI task
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI taskOther
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.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | All participants will be in the same arm. Receives: Other: MRI task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Children will be scanned either at 6-36 months or 6-11 years of age, depending on when the participants are enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start23 Jan 2023
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pollution; ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico, National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Claudia Lugo-Candelas, New York State Psychiatric Institute
- Investigators
- Claudia I Lugo-Candelas, PhD, Principal investigator, Columbia University Irving Medical Center/New York State Psychiatric instituteLigia Chavez, PhD, Principal investigator, University of Puerto RicoCristiane S Duarte, PhD, Principal investigator, Columbia University Irving Medical Center/New York State Psychiatric institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368493
- Sponsor's protocol ID
- 8232
- Other IDs
- R01ES032870-01
- Status last verified
- Aug 2026
- First submitted
- 5 May 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Air Pollution and Neurodevelopment: a Longitudinal Neuroimaging Study of Mechanisms and Early Risk for ADHD in Puerto Rican Children
- ClinicalTrials.gov ID
- NCT05368493
- Acronym / sponsor ID
- 8232
- Conditions
- Pollution; Exposure, Neurodevelopmental Disorders
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- University of Puerto Rico, National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Other: MRI taskAll participants will be in the same arm. |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI taskTask 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. | Other | All participants |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia I Lugo-Candelas, PhD principal investigator
Columbia University Irving Medical Center/New York State Psychiatric institute
Ligia Chavez, PhD principal investigator
University of Puerto Rico
Cristiane S Duarte, PhD principal investigator
Columbia University Irving Medical Center/New York State Psychiatric institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI task in people with Pollution; Exposure and Neurodevelopmental Disorders, run by New York State Psychiatric Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.