Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
With
National Center for Research Resources (NCRR)
Age
0–5
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age at least 6 months and less than 6 years
Diagnosis of cystic fibrosis with 2 clinical features consistent with CF and confirmed by either sweat chloride \>= 60 mEq/L (by quantitative pilocarpine iontophoresis) or by genotype with 2 identifiable mutations consistent with CF.
One throat or sputum microbiology culture positive for Pseudomonas aeruginosa (Pa) within 2 weeks to 12 months prior to screening.
Informed consent by parent or legal guardian.
You may not be if
History of adverse reaction to anesthesia or sedation.
History of aminoglycoside hypersensitivity.
History of unresolved anemia (hematocrit \< 30%) or thrombocytopenia (platelet count \< 100,000/mm3).
History of hemoptysis with 30 days prior to screening.
History of abnormal renal function (serum creatinine \> 1.5 times the upper limit of normal for age).
History of clinically documented chronic hearing loss.
Administration of any investigational drug within 30 days prior to screening.
Clareo Health | A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
