Children's Respiratory and Environmental Workgroup

NCT03213184 | Completed

• 6 other identifiers: 2017-08371UG3OD023282A536700SMPH\PEDIATRICS\PEDIATRICSProtocol V4.0, dated 11/13/185UH3OD023282-05
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 10

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.

Conditions

Asthma; Allergic Asthma; Allergies; Healthy

Keywords

Birth cohort; asthma; allergies

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in the first second (FEV1)

  Spirometry, also known as FEV1, will be measured at all ages to asses level of asthma.

  7 years

Secondary Outcomes (2)

• Asthma Control Test (ACT)

  7 years

• Immunoglobulin E (IgE)

  7 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Inability or unwillingness of a participant to give informed consent or assent (if required) or comply with study protocol.
• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• University of Chicago: collaborator
• University of California, San Francisco: collaborator
• Harvard School of Public Health (HSPH): collaborator
• University of Arizona: collaborator

Study Sites (10)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UW Madison

Madison, Wisconsin, 53792, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

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

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• James Gern, MD

  UW Madison

  PRINCIPAL INVESTIGATOR

• Daniel Jackson, MD

  UW Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 11, 2017
• Study Start: December 26, 2017
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)