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World Trade Center Adolescent Health Study

2017년 1월 23일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

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).

연구 유형

관찰

등록 (실제)

402

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • New York
      • New York, New York, 미국, 10016
        • NYU School of Medicine

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

12년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pulmonary Function Testing
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: One time
Fasting insulin and blood glucose will be assessed.
One time

2차 결과 측정

결과 측정
측정값 설명
기간
Lipid levels
기간: One time
Fasting blood draw will be performed.
One time
Psychosocial stress and mental health outcomes
기간: 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
기간: One time
We will measure tobacco smoke exposure from salivary cotinine.
One time

기타 결과 측정

결과 측정
측정값 설명
기간
Physical activity questionnaire
기간: One time
Questionnaire adapted from the International Physical Activity Questionnaire-Short last seven days
One time
Diet history questionnaire
기간: One time
web-based Diet History Questionnaire II developed by the National Cancer Institute
One time

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Leonardo Trasande, MD, MPP, NYU Sch of Med

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 12월 1일

기본 완료 (실제)

2016년 3월 1일

연구 완료 (실제)

2016년 3월 1일

연구 등록 날짜

최초 제출

2014년 1월 22일

QC 기준을 충족하는 최초 제출

2014년 2월 18일

처음 게시됨 (추정)

2014년 2월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2017년 1월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 1월 23일

마지막으로 확인됨

2017년 1월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • S12-03116
  • U01OH010394 (미국 NIH 보조금/계약)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .