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World Trade Center Adolescent Health Study

23 januari 2017 uppdaterad av: NYU Langone Health

Early Identification of World Trade Center Conditions in Adolescents

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.

Studieöversikt

Detaljerad beskrivning

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).

Studietyp

Observationell

Inskrivning (Faktisk)

402

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • New York
      • New York, New York, Förenta staterna, 10016
        • NYU School of Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 20 år (Barn, Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

The study population for the present proposal will be drawn from the pediatric component of the WTCHR, a cohort of 71,436 adults and children who were first interviewed in 2003-04. To further investigate the associations of WTC exposures with health outcomes, we will compare health parameters in the cohort of WTCHR registrants with 225 subjects in a control cohort drawn from pediatric and adolescent clinics in Manhattan and Brooklyn.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Lipid levels
Tidsram: One time
Fasting blood draw will be performed.
One time
Psychosocial stress and mental health outcomes
Tidsram: One time
  1. 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
One time
Tobacco smoke exposure
Tidsram: One time
We will measure tobacco smoke exposure from salivary cotinine.
One time

Andra resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Leonardo Trasande, MD, MPP, NYU Sch of Med

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2013

Primärt slutförande (Faktisk)

1 mars 2016

Avslutad studie (Faktisk)

1 mars 2016

Studieregistreringsdatum

Först inskickad

22 januari 2014

Först inskickad som uppfyllde QC-kriterierna

18 februari 2014

Första postat (Uppskatta)

21 februari 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 januari 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 januari 2017

Senast verifierad

1 januari 2017

Mer information

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