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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 (HSPH)
University of Arizona
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease
Asthma Allergic Asthma Allergies Healthy

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.

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Study Type : Observational
Estimated Enrollment : 4817 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Children's Respiratory and Environmental Workgroup (CREW)02
Actual Study Start Date : December 26, 2017
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples With DNA
  • 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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213184


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Wisconsin
UW Madison
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
University of Chicago
University of California, San Francisco
Harvard School of Public Health (HSPH)
University of Arizona
Investigators
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Principal Investigator: James Gern, MD UW Madison
Principal Investigator: Daniel Jackson, MD UW Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: 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 )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Birth cohort
asthma
allergies
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases