Office for Human Research Protections (OHRP)

Requesting IRB:

University of North Carolina - Chapel Hill

Study Summary:

The above-referenced research protocol proposes to study the changes in bronchoalveolar lavage fluid (BALF) of infants diagnosed with cystic fibrosis in the neonatal period. The proposed study would enroll infants with a clinical diagnosis of cystic fibrosis in the neonatal period and would obtain BALF from these infants via flexible fiberoptic bronchoscopy at three time points: (1) after diagnosis, within the first 6 weeks after birth; (2) at 6 months of age; and (3) at 12 months of age. The goals of the proposed study are to: (a) quantify mucin in BALF and compare quantities before infection vs. after infection onset in cystic fibrosis; (b) correlate mucin quantity with measures of infection (quantitative bacteriology) and inflammation (cell numbers, neutrophil products, and inflammatory cytokines); and (c) isolate mucus plugs and characterize their histology before and after infection, in order to more accurately describe early relationships among mucus obstruction, infection and inflammation.

Funding Source:

National Heart, Lung and Blood Institute (NHBLI), National Institutes of Health (NIH)