Clinical trial NCT04215783: Childhood Allergy and the Neonatal Environment
Official title: Childhood Allergy and the Neonatal Environment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Asthma in Children
Allergy
Keywords: Allergy, Asthma, Children, Birth cohort
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Duke University
First posted: 2020-01-02
Enrollment: 499
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The CANOE study will provide an opportunity to collect novel longitudinal samples not available from the current CANOE birth cohorts, as well as enhanced and standardized environmental sampling in early life. One of the main goals of this study is to gather data and specimens, beginning in the prenatal periods, that will assess environmental exposures to toxins and microbes, and host characteristics including genetics, epigenetics, gene expression, the proteome and metabolome, microbial colonization and viral respiratory infections. The main study outcomes will be important interim conditions (e.g., recurrent wheeze, early multiple sensitization) that are highly associated with the development of asthma. Additional outcomes (perinatal outcomes, growth, neurocognitive development) will be collected as part of the collaborative Environmental Influences on Child Health Outcomes (ECHO)-wide Cohort Data Collection Protocol.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Maternal age greater than or equal to 18 years at the time of study enrollment.

Exclusion Criteria:

1. Maternal HIV infection at time of delivery.
2. Plans for the family to move out of the geographic area during the period of the study.
3. Does not speak English.
4. Current maternal use of progesterone during pregnancy to prevent preterm birth.

   * Progesterone use is only an exclusion if currently being taken at time of enrollment for preterm birth. Previous use to prevent preterm birth or use at any time for other indications is allowed.
5. Pregnancy is a result of an embryo donor (egg and sperm donor pregnancies are permitted).
6. 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.

Primary outcomes:
measure: Number of children with recurrent wheeze
timeFrame: 3 years
measure: Number of children with early aeroallergen sensitization
timeFrame: 2 years
Secondary outcomes:
measure: Number of children with Atopic dermatitis (AD)
timeFrame: 3 years
measure: Number of children with food allergies
timeFrame: 3 years
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health Systems
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: UW Madison
name: Anne Marie Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UW Madison
name: James Gern, MD
role: PRINCIPAL_INVESTIGATOR
References: