AsthmaNCT01978288
Upper Airway Microbial Development During the First Year of Life
An observational study of Asthma, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 minute to 1 week
- Conditions the study is for
- Asthma
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 1 week
- All sexes
- No healthy volunteers
- Child
Study population: Infants whose mother has asthma; Infants whose parents are without atopy - asthma, eczema, seasonal allergies
Who may be able to join
- Moms age 14 and older (will sign Informed Consent Statement (ICS), not an assent)
- Mother of child enrolled must have a physician diagnosis of asthma or being treated for asthma (for 140 subjects; 40 subjects will be recruited from mothers and fathers without atopy - asthma, eczema, seasonal allergies)
- Child must be enrolled during first week of life
- Signed informed consent from parent(s) or legal guardian(s)
Who cannot join
- Child has a history of wheezing or underlying lung disease
- Respiratory complications at birth (airway support higher then nasal cannula)
- Born earlier then 37 weeks gestation
- Congenital heart defects (not including Patent Ductus Arteriosus (PDA), hemodynamically insignificant Ventricular Septal Defect (VSD) or Atrial Septal Defect (ASD)
- Underlying neuromuscular disease
- Severe upper airway obstruction, sleep apnea, tracheomalacia, or laryngomalacia
Show all 15Show fewer
- Hydrocephalus
- History of seizures
- History of arrhythmia and baseline oxygenation level <90% on room air
- Infant is non-viable
- Severe gastroesophageal reflux
- Prior chest surgery or structural abnormalities of the lungs or chest wall
- Has a history of adverse reaction to chloral hydrate
- Ward of the state
- Any physical finding(s) that would compromise the safety of the subject or the quality of the study data as determined by the site investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed description
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.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Birth and 12 months (+/- 2 months)
Secondary outcomes (2)
Change in inflammatory markers (IL-4, IL-5 and IL-13) during first 12 months of life.
- Determine if the microbiome at age 18 months (+/- 6 months) is associated with decreased lung function and/or increased inflammatory markers.
Measured: Birth and 12 months (+/- 2 months)
Change in airway function measurements FEV0.5 during 12 months of life.
Pulmonary measurements will be obtained. We will look at changes over time in FEV0.5.
Measured: Birth and 12 months (+/- 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startJan 2014
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Kirsten Kloepfer, Indiana University
- Investigators
- Kirsten Kloepfer, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978288
- Sponsor's protocol ID
- 1308055098
- Other IDs
- K23AI135094, 5K12HD068371
- Status last verified
- Apr 2026
- First submitted
- 25 Oct 2013
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Airway Microbial Development During the First Year of Life
- ClinicalTrials.gov ID
- NCT01978288
- Acronym / sponsor ID
- 1308055098
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2014
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 minute to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants whose mother has asthma; Infants whose parents are without atopy - asthma, eczema, seasonal allergies
Key inclusion criteria (4 listed)
- Moms age 14 and older (will sign Informed Consent Statement (ICS), not an assent)
- Mother of child enrolled must have a physician diagnosis of asthma or being treated for asthma (for 140 subjects; 40 subjects will be recruited from mothers and fathers without atopy - asthma, eczema, seasonal allergies)
- Child must be enrolled during first week of life
- Signed informed consent from parent(s) or legal guardian(s)
Key exclusion criteria (15 listed)
- Child has a history of wheezing or underlying lung disease
- Respiratory complications at birth (airway support higher then nasal cannula)
- Born earlier then 37 weeks gestation
- Congenital heart defects (not including Patent Ductus Arteriosus (PDA), hemodynamically insignificant Ventricular Septal Defect (VSD) or Atrial Septal Defect (ASD)
- Underlying neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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)
Change in airway function measurements FEV0.5 during 12 months of life.
Time frame: Birth and 12 months (+/- 2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Kloepfer, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in airway bacteria diversity during first 12 months of life. (time frame: Birth and 12 months (+/- 2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.