Childhood Allergy and the Neonatal Environment

NCT04215783 | Active Not Recruiting

• 7 other identifiers: 2019-11035UH3OD0232821U24AI152177-01MSN236000A536770SMPH/PEDIATRICS/AIRProtocol Version 1/23/2026
• Study Type: observational
• Target: 499
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this research study is to study the relationship between childhood asthma, allergies, and early-life environmental factors that may cause childhood asthma and allergies. Previous birth cohort studies have found early-life environmental factors such as allergies, pollutants, viruses and bacteria have all contributed to the development of asthma and allergies. Investigators are doing this research because there continues to be a strong need to understand the root causes of asthma and allergies. The CANOE study is an observational cohort study, which means investigators are not asking participants or participant's child to change their medications and investigators will not be giving participants or participant's child a study drug.

Conditions

Asthma in Children; Allergy

Keywords

Allergy, Asthma, Children, Birth cohort

Outcome Measures

Primary Outcomes (3)

• Number of children with recurrent wheeze

  Number of children with recurrent wheezing will be reported. Recurrent wheeze, defined as at least 2 episodes of wheeze with one occurring in the last 12 months of study participation for children between 2 and 3 years of age.

  3 years

• Number of children with early aeroallergen sensitization

  Number of children with early aeroallergen sensitization will be reported. Early aeroallergen sensitization, defined as sensitization to at least one aeroallergens by age 2 years.

  2 years

• Number of children diagnosed with asthma

  Number of children who diagnosed, either by a doctor or self-report, at age 6 or 7 years.

  4 years

Secondary Outcomes (3)

• Number of children with Atopic dermatitis (AD)

  3 years

• Number of children with food allergies

  3 years

• Lung function

  4 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study participants of CANOE will consist of four ethnically diverse cohorts from predominantly urban and suburban families at 4 sites. Previous studies have identified common themes in populations of children who differ by ethnicity and environmental exposures. These include inverse relationships between wheezing and/or atopy and exposure to specific microbes and allergens in early life. Obtaining prospective data from newly recruited participants during the prenatal period offers multiple opportunities to optimize sample collection for assessment of environmental exposures and enhance the scientific value of the CREW consortium. To enrich the cohort for the development of wheezing and allergic sensitization, we will enroll participants with a family history of asthma or allergies.

You may qualify if:

• History of or concurrent asthma or allergic rhinitis (hay fever) in either biologic parent or sibling (at least one shared biological parent) by parental report. The presence of paternal or sibling allergy or asthma will be ascertained by maternal report.
• Maternal age greater than or equal to 18 years at the time of study enrollment.

You may not qualify if:

• Maternal HIV infection at time of delivery.
• Plans for the family to move out of the geographic area during the period of the study.
• Does not speak English.
• Current maternal use of progesterone during pregnancy to prevent preterm birth.
• Pregnancy is a result of an embryo donor (egg and sperm donor pregnancies are permitted).
• 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
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Duke University: collaborator

Study Sites (4)

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cryopreserved samples of serum, plasma, urine, and nasal secretions or wash fluid, will be analyzed for proteins or metabolites that may serve as biomarkers for exposures or for study outcomes. A genetic sample (blood buffy coat or saliva) from the mother and child will be saved (if they agree) for use later to look at DNA, RNA or both.

MeSH Terms

Conditions

Hypersensitivity; Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Anne Marie Singh, MD

  UW Madison

  PRINCIPAL INVESTIGATOR

• James Gern, 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: December 30, 2019
• First Posted: January 2, 2020
• Study Start: March 4, 2020
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)