Trials / Completed
CompletedNCT02068183
World Trade Center Adolescent Health Study
Early Identification of World Trade Center Conditions in Adolescents
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 402 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 12 Years – 20 Years
- Healthy volunteers
- Accepted
Summary
The proposed study builds upon preliminary studies in self-selected populations to identify opportunities for early identification of World Trade Center-related health consequences in adolescents. If adverse health consequences are identified, proactive cardiometabolic and pulmonary screening of exposed children may be indicated, with targeted interventions intended to prevent development of chronic obstructive pulmonary disease, and adverse cardiometabolic outcomes in adulthood.
Detailed description
The study will assess the potential for longer-latency cardiometabolic and pulmonary effects of early life exposure to the World Trade Center (WTC) disaster, and to identify opportunities for early identification of WTC-related health consequences. Preliminary data from the only investigators who regularly provide clinical care to children who lived/attended school near the WTC site identified decrements in spirometry associated with dust cloud exposure, and a remarkably high frequency of cardiometabolic risk factors. Findings from this clinically, self-selected population cannot be extrapolated to the entire population of children who were exposed to the disaster but nonetheless suggest that further study is warranted of the possible metabolic and cardiovascular consequences of WTC exposures. If associated with WTC exposures in a larger, more representative sample, two new and innovative techniques, oscillometry and pulse wave velocity assessment, hold great promise for earlier detection of WTC-related pulmonary and cardiometabolic disease, for whom dietary, environmental and medication interventions may prevent disease progression in later life. The study will recruit 225 adolescents who respond to the WTC Health Registry (WTCHR), the most representative pediatric population and best-characterized from an environmental exposure standpoint. Connecting the study to the WTCHR also presents efficiency of federal resource utilization, providing more objective clinical data to support self-reported findings of increased persistent respiratory symptoms captured by the WTCHR, thereby improving reliability of the registry data. We will compare pulmonary and cardiometabolic outcomes to carefully matched (age, race/ethnicity, gender, and socioeconomic status) and unexposed control (not resident/attending school south of Houston Street on September 11, 2001) populations from NYU School of Medicine affiliated primary care (private and public clinics).
Conditions
- Asthma
- Hypertension
- Cardiovascular Risk Factor
- Insulin Resistance
- Stress Disorders, Post-Traumatic
- Exposure to Toxic Dust
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2014-02-21
- Last updated
- 2017-01-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02068183. Inclusion in this directory is not an endorsement.