NCT01978288Active, not recruiting
Upper Airway Microbial Development During the First Year of Life
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 180 (estimated)
- First submitted
- 25 Oct 2013
- Start date
- 1 Jan 2014
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Indiana University
- Diseases
- Asthma
- NCT number
- NCT01978288
What you commit to
- Study type: Observational
- Planned participants: 180
- From 1 Jan 2014 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior chest surgery or structural abnormalities of the lungs or chest wall
Other illness
- Child has a history of wheezing or underlying lung disease
- Congenital heart defects (not including Patent Ductus Arteriosus (PDA), hemodynamically insignificant Ventricular Septal Defect (VSD) or Atrial Septal Defect (ASD)
- Underlying neuromuscular disease
- History of seizures
- History of arrhythmia and baseline oxygenation level \<90% on room air
- Has a history of adverse reaction to chloral hydrate
Other
- Respiratory complications at birth (airway support higher then nasal cannula)
- Born earlier then 37 weeks gestation
- Severe upper airway obstruction, sleep apnea, tracheomalacia, or laryngomalacia
- Hydrocephalus
- Infant is non-viable
- Severe gastroesophageal reflux
- 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
Who the study is looking for
- 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)
Age in the registry: 1 Minute to 1 week · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Riley Hospital for Children at Indiana University Health Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.