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Upper Airway Microbial Development During the First Year of Life

NCT01978288

Active Not RecruitingN/A

Sponsor: Indiana University

Conditions: Asthma

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 1 Minute to 1 Week

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (1)

Indianapolis, Indiana, United States