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Children's Respiratory and Environmental Workgroup (CREW 02)

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ClinicalTrials.gov Identifier: NCT03213184
Recruitment Status : Enrolling by invitation
First Posted : July 11, 2017
Last Update Posted : April 13, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of Chicago
University of California, San Francisco
Harvard School of Public Health
University of Arizona
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date June 28, 2017
First Posted Date July 11, 2017
Last Update Posted Date April 13, 2021
Actual Study Start Date December 26, 2017
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 6, 2017)
Forced Expiratory Volume in the first second (FEV1) [ Time Frame: 7 years ]
Spirometry, also known as FEV1, will be measured at all ages to asses level of asthma.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 6, 2017)
  • Asthma Control Test (ACT) [ Time Frame: 7 years ]
    Asthma symptoms of children leading to differing asthma severity (none, mild, moderate, severe) will be measured using the ACT questionnaire at all ages.
  • Immunoglobulin E (IgE) [ Time Frame: 7 years ]
    Total IgE will be measured serologically and will be used to determine level of allergy in all ages over 7 years.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Children's Respiratory and Environmental Workgroup
Official Title Children's Respiratory and Environmental Workgroup (CREW)02
Brief Summary The environment during the prenatal period and in early life is a major contributor to the risk of developing childhood asthma. Birth cohort studies from single research centers have identified several factors that affect the risk for developing childhood asthma, including being exposed in early life to allergens, pollutants, viruses and bacteria, and psychosocial stress. Despite such advances, further progress in understanding the root causes of asthma have been hampered by the small size of previous studies, which makes it difficult to: 1) identify asthma risk factors with certainty, 2) know how environmental factors across the United States (U.S.) affect asthma, and 3) whether there are critical ages when pregnant mothers, infants and young children are particularly susceptible to these influences. Furthermore, different research groups tend to use different methods to study asthma, making it difficult to either compare or pool findings. One other challenge is that there are several types (i.e. phenotypes, endotypes) of childhood asthma, but these are poorly understood. To help overcome these challenges, investigators leading 12 asthma birth cohorts across the U.S. have established the Children's Respiratory Research Workgroup (CREW) consortium. CREW proposes to identify specific types of childhood asthma, develop an understanding of what early life environmental influences cause these different types of asthma and when, and identify targets for future efforts aimed at preventing childhood asthma.
Detailed Description CREW is an NIH-funded project consisting of 12 individual U.S. birth cohorts and two scientific centers working together to identify phenotypes and causes of childhood asthma. CREW will include data from a large number of children (over 9,000 at birth, 6,000-7,000 who are still being followed, and at least 5,667 expected to enroll in CREW) and their families, with broad diversity in terms of ethnicity, family characteristics, neighborhoods and geographic locations. One of the primary goals of CREW is to put together sets of data and samples of participating cohorts to identify phenotypes of childhood asthma (i.e. specific subtypes of asthma that can be distinguished by clinical features such as natural history, triggers, exacerbation frequency, concurrent allergies, lung function, sex, etc). As we obtain mechanistic insights about personal and early life risk factors, we will connect asthma phenotypes with underlying causes and pathogenic mechanisms to define endotypes of childhood asthma.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • Blood samples separated into plasma/serum aliquots and red blood cell/buffy coat
  • Urine
  • Stool
  • Nasal wash/blow/lavage
  • Nasal Brushing collected cells expanded in cell culture and cryopreserved
  • Baby teeth (dependent on number returned and amount of material needed for assay)
  • Hair and toenail clippings
  • Saliva
  • Home dust samples
Sampling Method Non-Probability Sample
Study Population CREW consortium represent a diverse national sample of children and families recruited over the past 30 years into 12 early life and birth cohort studies that focused on asthma. The total combined study population is 8,985 at the time of birth. The study population is quite diverse in terms of current age (ages <1 through 36 years), date of recruitment (1980-2017), race/ethnicity, and risk of asthma. There is considerable variation in the geographic locations of participants, with representation from East Coast (Baltimore, Boston, New York City), Midwest (Cincinnati, Detroit, Madison, Marshfield), South (Nashville, St. Louis) and West (Tucson). Most children are healthy (control population) while some have asthma or some form of allergic disease.
Condition
  • Asthma
  • Allergic Asthma
  • Allergies
  • Healthy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: December 1, 2020)
4817
Original Estimated Enrollment
 (submitted: July 6, 2017)
5667
Estimated Study Completion Date August 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Participant and/or parent guardian must be able to understand and provide informed consent or assent (if required).
  2. Participation in one of the 10 cohorts that make up CREW.

Exclusion Criteria:

  1. Inability or unwillingness of a participant to give informed consent or assent (if required) or comply with study protocol.
  2. Past or current medical problems or findings from physical examination or laboratory testing which, in the opinion of the investigator or designee, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03213184
Other Study ID Numbers 2017-0837
1UG3OD023282 ( U.S. NIH Grant/Contract )
A536700 ( Other Identifier: UW Madison )
SMPH\PEDIATRICS\PEDIATRICS ( Other Identifier: UW Madison )
Protocol V4.0, dated 11/13/18 ( Other Identifier: HS-IRB, UW Madison )
5UH3OD023282-05 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor University of Wisconsin, Madison
Collaborators
  • National Institutes of Health (NIH)
  • University of Chicago
  • University of California, San Francisco
  • Harvard School of Public Health
  • University of Arizona
Investigators
Principal Investigator: James Gern, MD UW Madison
Principal Investigator: Daniel Jackson, MD UW Madison
PRS Account University of Wisconsin, Madison
Verification Date December 2020