Upper Airway Microbial Development During the First Year of Life
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|ClinicalTrials.gov Identifier: NCT01978288|
Recruitment Status : Active, not recruiting
First Posted : November 7, 2013
Last Update Posted : August 4, 2020
|Condition or disease|
With the prevalence of asthma increasing each decade, our focus has shifted from treatment to understanding the pathogenesis of asthma so we may develop methods of prevention. With the advent of new bacterial detection techniques, we have the opportunity to examine the infant microbiome prior to the development of wheezing and subsequent asthma. Based on our knowledge that certain bacteria are associated with recurrent wheezing, we believe that an increase in pathogenic bacteria alters the airway epithelium resulting in airway inflammation. This chronic inflammation leads to airway obstruction, resulting in recurrent wheezing. By prospectively following children up to two years we have the opportunity to determine if changes seen in early infancy are established early and persist until 2 years of age. In addition, we propose to determine if the microbiome contributes to airway obstruction and episodes of wheezing with respiratory illness. This study tests the hypothesis that an increase in pathogenic bacteria within the infant airway leads to increased airway inflammation, decreased airway function and ultimately airway obstruction throughout the first one to two years of life.
The study has 3 Cohorts:
Cohort 1: Newborns with asthmatic mothers with enrollment from May 7, 2014 to June 1, 2016. Newborns from this cohort meet the below inclusion and exclusion criteria, however they follow a study visit schedule that follows them for 18 months (+/- 6 months).
Cohort 2: Newborns with asthmatic mothers with enrollment from June 2, 2016 going forward. Newborns from this cohort meet the below inclusion and exclusion criteria, however they follow a study visit schedule that follows them for 12 months (+/- 2 months).
Cohort 3: Newborns with healthy parents without atopy from June 2, 2016 going forward. Newborns from this cohort meet the below inclusion and exclusion criteria, however they follow a study visit schedule that follows them for 12 months (+/- 2 months).
Once enrolled, study procedures will consist of: collection of nasal swabs and fluid, stool specimens, and throat swabs, at enrollment visit (first week of life), 3-5 weeks of age (Visit 2), 3-5 months (Visit 3), and 12 months +/- 2 months (Visit 4); blood draw at Visits 3 and 4; spirometry will be performed at Visits 2, 3 and 4: non-sedated infant pulmonary function tests will be conducted at all visits for all cohorts; at Visits 3 and 4, sedated infant pulmonary function tests are optional for Cohorts 1 and 2 only. Finally, surveys will be completed about every two months starting at about two months, then four weeks after Visit 3, and about every 8 weeks until Visit 4, to review infection history, medication (including antibiotics) history and wheezing history.
|Study Type :||Observational|
|Estimated Enrollment :||180 participants|
|Official Title:||Upper Airway Microbial Development During the First Year of Life|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Cohort 1 Newborns with asthmatic mothers
Infants born to mothers who have diagnosis of Asthma that were enrolled in study from 5/7/14 to 6/1/16.
Cohort 2 Newborns with asthmatic mothers
Infants born to mothers who have a diagnosis of Asthma with enrollment from June 2, 2016 going forward.
Cohort 3 Newborns with healthy parents
Infants born to healthy parents without atopy (asthma, eczema, seasonal allergies) from June 2, 2016 going forward.
- Change in airway bacteria diversity during first 12 months of life. [ Time Frame: Birth and 12 months (+/- 2 months) ]Will use microbiome diversity measurements to determine if changes in diversity occur over time.
- Change in inflammatory markers (IL-4, IL-5 and IL-13) during first 12 months of life. [ Time Frame: Birth and 12 months (+/- 2 months) ]c. Determine if the microbiome at age 18 months (+/- 6 months) is associated with decreased lung function and/or increased inflammatory markers.
- Change in airway function measurements FEV0.5 during 12 months of life. [ Time Frame: Birth and 12 months (+/- 2 months) ]Pulmonary measurements will be obtained. We will look at changes over time in FEV0.5.
Biospecimen Retention: Samples With DNA
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): NCT01978288
|United States, Indiana|
|Riley Hospital for Children at Indiana University Health|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Kirsten Kloepfer, MD||Indiana University School of Medicine|