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| ID | Type | Description | Link |
|---|---|---|---|
| K23AI135094 | U.S. NIH Grant/Contract | View source | |
| 5K12HD068371 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in airway bacteria diversity during first 12 months of life. | Will use microbiome diversity measurements to determine if changes in diversity occur over time. | Birth and 12 months (+/- 2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory markers (IL-4, IL-5 and IL-13) during first 12 months of life. | c. Determine if the microbiome at age 18 months (+/- 6 months) is associated with decreased lung function and/or increased inflammatory markers. | Birth and 12 months (+/- 2 months) |
| Change in airway function measurements FEV0.5 during 12 months of life. |
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Inclusion Criteria:
Exclusion Criteria:
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Infants whose mother has asthma; Infants whose parents are without atopy - asthma, eczema, seasonal allergies
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten Kloepfer, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Nasal swabs, throat swabs, nasal fluid, blood, and stool specimens will be retained
Pulmonary measurements will be obtained. We will look at changes over time in FEV0.5. |
| Birth and 12 months (+/- 2 months) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |