Upper Airway Microbial Development During the First Year of Life
Running, not enrolling
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT01978288
- Run by
- Indiana University
- People needed
- 180
- Starts
- 2014-01-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-23
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
- 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
Where it is running
- Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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