Respiratory Medicine Research
Current studies being conducted in the Respiratory Medicine department at Children's:
BONUS (Baby Observational and Nutritional Study)
Cystic fibrosis (CF) is a life-shortening disease that causes breathing and digestive problems, but can now be diagnosed at the time of birth. Lung function is very hard to measure in infants, but growth is not. In this study the investigators aim to define growth in infants with CF in the first year of life with research quality precision and to understand factors that interfere with good growth.
This is a multi-center observational clinical study with a nested interventional PERT sub-study. The observational study is designed to follow in a prospective manner incident cases of CF for up to 12 months. The PERT sub-study is a randomized, double-blind, crossover sub-study designed to evaluate the efficacy and safety of two doses of PERT (pancreatic enzyme replacement therapy) for improving coefficient of fat absorption (CFA) in the stool of infants with CF. All subjects will be enrolled in the observational study (a cohort of approximately 225 subjects) and a subset of the observational study subjects will also be enrolled in the PERT sub-study (approximately 24 subjects) at selected sites. Children’s Medical Center Dallas will not be participating in the PERT sub-study.
Target population is newborns up to 3 months old with a confirmed diagnosis of cystic fibrosis
The above information was taken from and can be found on the ClinicalTrial.gov website.
Carolyn Cannon, MD
For more information, contact:
Andrew Hebert, RRT, CCRC (214) 456-5618