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World Trade Center Adolescent Health Study

Early Identification of World Trade Center Conditions in Adolescents

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02068183
Enrollment
402
Registered
2014-02-21
Start date
2013-12-31
Completion date
2016-03-31
Last updated
2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Cardiovascular Risk Factor, Exposure to Toxic Dust, Hypertension, Insulin Resistance, Stress Disorders, Post-Traumatic

Keywords

World Trade Center exposure, cardiovascular risk, insulin resistance, post-traumatic stress, pulmonary disease

Brief 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).

Interventions

None listed

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
Yes

Inclusion criteria

* WTCHR participants (exposed group): previous response to WTCHR, born between September 11, 1993 and September 10, 2001 * Controls who are did not live or attend school south of Canal Street on September 11, 2001, matched for age, race/ethnicity, socioeconomic status and other characteristics

Exclusion criteria

* Inability to follow procedures. * Serious lung or heart condition * Heart or lung surgery * Uncontrolled asthma * Current upper respiratory infection * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Insulin resistanceOne timeFasting insulin and blood glucose will be assessed.
OscillometryOne timeOscillometry provides a noninvasive measure of the impedance to airflow within the lung. An externally-generated pressure impulse is applied during tidal breathing in a seated position for 30 seconds, and volume and flow measurements are made.
PlethysmographyOne timeMeasured lung volumes will include total lung capacity (TLC), vital capacity (VC), residual volume (RV), and functional residual capacity (FRC) and will be compared to normative values, using established pediatric reference equations.
Blood PressureOne timeWe will perform assess systolic (first Korotkoff phase) and diastolic (fifth Korotkoff phase) BP three consecutive times in all participants.
Arterial Wall StiffnessOne timePulse Wave Velocity (PWV) will be measured using the SphygmoCor CPV System (AtCor Medical, Sydney, Australia). PWV measures the speed for the pressure wave generated by cardiac ejection to reach the periphery.
Heart Rate VariabilityOne timeAssessment of Heart Rate Variability (HRV) will be performed using the SphgymoCor SCOR-CPV device (AtCor Medical, Sydney, Australia).
Pulmonary Function TestingOne timeWe will perform spirometry according to standards outlined by the American Thoracic Society and the European Respiratory Society. Specifically, we will assess forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC ratio, and forced expiratory flow over 25-75% of the vital capacity (FEF25-75%; Jaeger Masterscreen IOS; Carefusion, Yorba Linda, CA). National Health and Nutrition Examination Survey (NHANES) III reference equations will be used to determine normative values, with statistical analysis to be applied to percents of predicted volumes based on these norms.

Secondary

MeasureTime frameDescription
Lipid levelsOne timeFasting blood draw will be performed.
Psychosocial stress and mental health outcomesOne time1. WTC disaster trauma-We will measure psychologically relevant WTC exposure, using questions about direct exposure, family/friend exposure, and media exposure. 2. Other lifetime trauma 3. Depression 4. Substance abuse, and other diagnoses 5. Post-traumatic stress disorder 6. Functional impairment 7. Mental health service utilization
Tobacco smoke exposureOne timeWe will measure tobacco smoke exposure from salivary cotinine.

Other

MeasureTime frameDescription
Diet history questionnaireOne timeweb-based Diet History Questionnaire II developed by the National Cancer Institute
Physical activity questionnaireOne timeQuestionnaire adapted from the International Physical Activity Questionnaire-Short last seven days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026