Upper Airway Microbial Development During the First Year of Life

NCT ID: NCT01978288

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2025-12-31

Brief 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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Cohort 2 Newborns with asthmatic mothers

Infants born to mothers who have a diagnosis of Asthma with enrollment from June 2, 2016 going forward.

No interventions assigned to this group

Cohort 3 Newborns with healthy parents

Infants born to healthy parents without atopy (asthma, eczema, seasonal allergies) from June 2, 2016 going forward.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Moms age 14 and older (will sign Informed Consent Statement (ICS), not an assent)

2. 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)

3. Child must be enrolled during first week of life

4. Signed informed consent from parent(s) or legal guardian(s)

Exclusion Criteria

1. Child has a history of wheezing or underlying lung disease

2. Respiratory complications at birth (airway support higher then nasal cannula)

3. Born earlier then 37 weeks gestation

4. Congenital heart defects (not including Patent Ductus Arteriosus (PDA), hemodynamically insignificant Ventricular Septal Defect (VSD) or Atrial Septal Defect (ASD)

5. Underlying neuromuscular disease

6. Severe upper airway obstruction, sleep apnea, tracheomalacia, or laryngomalacia

7. Hydrocephalus

8. History of seizures

9. History of arrhythmia and baseline oxygenation level <90% on room air

10. Infant is non-viable

11. Severe gastroesophageal reflux

12. Prior chest surgery or structural abnormalities of the lungs or chest wall

13. Has a history of adverse reaction to chloral hydrate

14. Ward of the state

15. 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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 1 Week
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Kirsten Kloepfer

Assistant Professor of Pediatric Pulmonology, Allergy and Sleep Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirsten Kloepfer, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

K23AI135094

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5K12HD068371

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1308055098

Identifier Type: -

Identifier Source: org_study_id