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Completed

NCT Number: NCT02068183

World Trade Center Adolescent Health Study

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pulmonary Function Testing

    Time frame: One time

    We 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.

  2. Oscillometry

    Time frame: One time

    Oscillometry 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.

  3. Plethysmography

    Time frame: One time

    Measured 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.

  4. Blood Pressure

    Time frame: One time

    We will perform assess systolic (first Korotkoff phase) and diastolic (fifth Korotkoff phase) BP three consecutive times in all participants.

  5. Arterial Wall Stiffness

    Time frame: One time

    Pulse 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.

  6. Heart Rate Variability

    Time frame: One time

    Assessment of Heart Rate Variability (HRV) will be performed using the SphgymoCor SCOR-CPV device (AtCor Medical, Sydney, Australia).

  7. Insulin resistance

    Time frame: One time

    Fasting insulin and blood glucose will be assessed.

Secondary outcomes

  1. Lipid levels

    Time frame: One time

    Fasting blood draw will be performed.

  2. Psychosocial stress and mental health outcomes

    Time frame: One time

    • WTC disaster trauma-We will measure psychologically relevant WTC exposure, using questions about direct exposure, family/friend exposure, and media exposure.
    • Other lifetime trauma
    • Depression
    • Substance abuse, and other diagnoses
    • Post-traumatic stress disorder
    • Functional impairment
    • Mental health service utilization
  3. Tobacco smoke exposure

    Time frame: One time

    We will measure tobacco smoke exposure from salivary cotinine.

Other outcomes

  1. Physical activity questionnaire

    Time frame: One time

    Questionnaire adapted from the International Physical Activity Questionnaire-Short last seven days

  2. Diet history questionnaire

    Time frame: One time

    web-based Diet History Questionnaire II developed by the National Cancer Institute

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Early Identification of World Trade Center Conditions in Adolescents

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 21, 2014
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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