Prevention of bronchiectasis in infants with cystic fibrosis
- Conditions
- bronchiectasis in cystic fibrosisRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12610001072000
- Lead Sponsor
- Telethon Kids Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 130
1. Children of either sex with a diagnosis of CF following detection via New Born Screening (NBS);
2. Participants who, in the opinion of the Investigator, are able to comply with the protocol for its duration;
3. Written informed consent signed and dated by parent/legal guardian according to local regulations
1. Born <30 weeks gestation;
2. Prolonged mechanical ventilation in the first 3 months of life;
3. Participation in another randomized controlled trial within the 3 months preceding inclusion in this study;
4. A significant medical disease or condition other than CF that is likely to interfere with the child’s ability to complete the entire protocol;
5. Previous major surgery except for meconium ileus;
6. Macrolide hypersensitivity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of children with radiologically-defined bronchiectasis[three years of age]
- Secondary Outcome Measures
Name Time Method extent and severity of bronchiectasis[three years of age];CF-related quality of life[three years of age];time to first pulmonary exacerbation[3 years of age];proportion of participants experiencing a pulmonary exacerbation[3 years of age];number of courses of inhaled or oral antibiotics[3 years of age];number of days of inhaled antibiotics[3 years of age];incidence of hospitalizations/Accident & Emergency visitsfor acute respiratory exacerbations[3 years of age];number of days of hospitalization and number of days of intravenous antibiotics for acute respiratory exacerbations[3 years of age];volume of trapped gas at age 3 years assessed using a low dose volumetric computed tomography scan[3 years of age];Body mass index[3 years of age]