World Trade Center Adolescent Health Study

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT02068183

Collaborator

(none)

402

Enrollment

Location

Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Hypertension Cardiovascular Risk Factor Insulin Resistance Stress Disorders, Post-Traumatic Exposure to Toxic Dust

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).

Study Design

Study Type:

Observational

Actual Enrollment :

402 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Early Identification of World Trade Center Conditions in Adolescents

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
World Trade Center exposed group After informed consent, anthropometric and blood pressure/brachial artery distensibility assessments; physical examination and environmental and respiratory history questionnaire completion; heart rate variability measurement; and spirometry/IOS will be performed on the World Trade Center exposed group. A research assistant well trained in pediatric phlebotomy will collect 23 mL of fasting blood. Spirometry and IOS, diet diary collection, lung volumes by plethysmography, and arterial wall stiffness.
Unexposed comparison group After informed consent, anthropometric and blood pressure/brachial artery distensibility assessments; physical examination and environmental and respiratory history questionnaire completion; heart rate variability measurement; and spirometry/IOS will be performed on the unexposed comparison group. A research assistant well trained in pediatric phlebotomy will collect 23 mL of fasting blood. Spirometry and IOS, diet diary collection, lung volumes by plethysmography, and arterial wall stiffness.

Arm

Intervention/Treatment

World Trade Center exposed group

After informed consent, anthropometric and blood pressure/brachial artery distensibility assessments; physical examination and environmental and respiratory history questionnaire completion; heart rate variability measurement; and spirometry/IOS will be performed on the World Trade Center exposed group. A research assistant well trained in pediatric phlebotomy will collect 23 mL of fasting blood. Spirometry and IOS, diet diary collection, lung volumes by plethysmography, and arterial wall stiffness.

Unexposed comparison group

After informed consent, anthropometric and blood pressure/brachial artery distensibility assessments; physical examination and environmental and respiratory history questionnaire completion; heart rate variability measurement; and spirometry/IOS will be performed on the unexposed comparison group. A research assistant well trained in pediatric phlebotomy will collect 23 mL of fasting blood. Spirometry and IOS, diet diary collection, lung volumes by plethysmography, and arterial wall stiffness.

Outcome Measures

Primary Outcome Measures

Pulmonary Function Testing [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.
Oscillometry [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.
Plethysmography [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.
Blood Pressure [One time]
We will perform assess systolic (first Korotkoff phase) and diastolic (fifth Korotkoff phase) BP three consecutive times in all participants.
Arterial Wall Stiffness [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.
Heart Rate Variability [One time]
Assessment of Heart Rate Variability (HRV) will be performed using the SphgymoCor SCOR-CPV device (AtCor Medical, Sydney, Australia).
Insulin resistance [One time]
Fasting insulin and blood glucose will be assessed.

Secondary Outcome Measures

Lipid levels [One time]
Fasting blood draw will be performed.
Psychosocial stress and mental health outcomes [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
Tobacco smoke exposure [One time]
We will measure tobacco smoke exposure from salivary cotinine.

Other Outcome Measures

Physical activity questionnaire [One time]
Questionnaire adapted from the International Physical Activity Questionnaire-Short last seven days
Diet history questionnaire [One time]
web-based Diet History Questionnaire II developed by the National Cancer Institute

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 20 Years

Sexes Eligible for Study:

All

Accepts 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