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Upper Airway Microbial Development During the First Year of Life

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ClinicalTrials.gov Identifier: NCT01978288
Recruitment Status : Recruiting
First Posted : November 7, 2013
Last Update Posted : May 28, 2018
Sponsor:
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)
Information provided by (Responsible Party):
Kirsten Kloepfer, Indiana University

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.

Condition or disease
Asthma

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 Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Upper Airway Microbial Development During the First Year of Life
Study Start Date : January 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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
Nasal swabs, throat swabs, nasal fluid, blood, and stool specimens will be retained


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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants whose mother has asthma; Infants whose parents are without atopy - asthma, eczema, seasonal allergies
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

Information from the National Library of Medicine

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


Contacts
Contact: Lori Shively, RN 317-948-7121 lashivel@iu.edu

Locations
United States, Indiana
Riley Hospital for Children at Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Kirsten Kloepfer, MD         
Sponsors and Collaborators
Indiana University
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)
Investigators
Principal Investigator: Kirsten Kloepfer, MD Indiana University School of Medicine

Responsible Party: Kirsten Kloepfer, Assistant Professor of Pediatric Pulmonology, Allergy and Sleep Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT01978288     History of Changes
Other Study ID Numbers: 1308055098
K23AI135094 ( U.S. NIH Grant/Contract )
5K12HD068371 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No