Parents of newly diagnosed infants with CF will be informed of the study by their doctors in their primary care facility, and will be given the opportunity to have a lung function test done at the children’s clinic at the University of Bern.
At the time of the lung function, parents will receive more detailed information about the study and will then have the opportunity to ask any questions.
Two visits to the children’s hospital in Bern for lung function measurements - the first between the ages of 6-10 weeks, and the second at the age of 1 year. Once per week during the first year of life, there will be a short telephone conversation with a Study Nurse. There will also be another visit to the children's hospital at the age of six years, and again at nine years, for the follow-up measurements.
Results from the lung function measurement make possible an early recognition of lung function impairment, and could lead to an earlier and more targeted treatment strategy. Weekly contact with the study nurses, who have weekly contact with the other parents in the study, provide an opportunity to ask questions about daily life with a CF infant. Most importantly, thanks to your participation, valuable information will be collected that would go to benefit future CF patients.
All of the children’s personal data collected during the study will be encrypted. This information will only be accessible to the professional researchers involved with the study. Professionals from the Swiss National Science Foundation, as well as the ethics committees, can also have access to the original data. However, the name of your child will under no circumstance be reported or published as a result of their participation.
Most newly diagnosed infants with CF can be included in the study. Exceptions would be: infants with severe co-morbidities (for example, a severe heart defect), or problems communicating with the parents due to language - parents should be able to speak German, English, French, or Italian.
Participation in the study is 100% voluntary. Withdrawal from the study will not impact your child’s medical treatment. You are free to leave at any time during the course of the study without consequence.
All examinations related to the study will be performed according to international stan-dards, and are harmless and painless for the infant. We use the latest, standardized and tested, commercially available equipment to perform the lung function tests. The study will be conducted in accordance with the law, and with internationally recognized policy.
The aforementioned examinations are free for the participants. We do not compensate for participation in this clinical study. However, travel and parking costs will be reimbursed up to a maximum of 100.-CHF per visit to the children’s hospital of the University of Bern (payment will be made in cash at the time of the lung function).
If, for whatever reason during the course of the study, your child’s health is unintentionally and unexpectedly impaired due to their partici-pation in the study, the study’s insurance will cover all related costs.