RECRUITINGOBSERVATIONAL
A Study of Females With CF Throughout Pregnancy and Post-partum, and Follow up of Their Offspring
An Observational Study to Evaluate the Impact of Pregnancy and Parenthood in Females With Cystic Fibrosis and Their Offspring in the CFTR Modulator Era.
About This Trial
In this study, investigators aim to study in detail the physical (including nutritional and pulmonary) and mental health of females with cystic fibrosis (CF) planning a pregnancy, during pregnancy, and in the early parenthood period. Additionally the health of offspring in infancy and early life will be studied to understand if further screening investigations or clinical care models should be part of clinical guidelines
Who May Be Eligible (Plain English)
Who May Qualify:
'Mama' sub-study:
- Written willing to sign a consent form obtained from participant.
- Under the care of Royal Brompton Hospital CF Reproductive and Maternal Health Service
- Age 16 years or above at time of recruitment
- Confirmed diagnosis of CF
- Planning a pregnancy or pregnant at time of recruitment.
- Ability to adhere to the required visits and investigations.
'Mini' sub-study:
- Written willing to sign a consent form obtained from participant's legal guardian.
- Infants who have one biological parent with a confirmed diagnosis of CF under care of Royal Brompton Hospital Adult CF Service
- Less than 12 months of age at first visit.
- Ability to adhere to the required visits and investigations.
'Midi' sub-study:
- Written willing to sign a consent form obtained from participant's legal guardian.
- Children who have one biological parent with a confirmed diagnosis of CF who is under the care of Royal Brompton Hospital Adult CF Service.
- Age three to six years at time of visit
- Ability to adhere to the required visits and investigations.
Who Should NOT Join This Trial:
'Mama' sub-study:
- Any significant health condition which would cause inability to comply with protocol based on investigator discretion.
- History of lung transplantation
'Mini' sub-study:
- Legal guardians' inability to provide consent to participate in the study.
- Mother of infant has significant comorbidities unrelated to CF which could affect infant outcomes based on investigator discretion.
'Midi' sub-study:
- Legal guardians' inability to provide consent to participate in the study.
- A significant health condition which is known to affect lung function or imaging based on investigator discretion
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
'Mama' sub-study:
* Written informed consent obtained from participant.
* Under the care of Royal Brompton Hospital CF Reproductive and Maternal Health Service
* Age 16 years or above at time of recruitment
* Confirmed diagnosis of CF
* Planning a pregnancy or pregnant at time of recruitment.
* Ability to adhere to the required visits and investigations.
'Mini' sub-study:
* Written informed consent obtained from participant's legal guardian.
* Infants who have one biological parent with a confirmed diagnosis of CF under care of Royal Brompton Hospital Adult CF Service
* Less than 12 months of age at first visit.
* Ability to adhere to the required visits and investigations.
'Midi' sub-study:
* Written informed consent obtained from participant's legal guardian.
* Children who have one biological parent with a confirmed diagnosis of CF who is under the care of Royal Brompton Hospital Adult CF Service.
* Age three to six years at time of visit
* Ability to adhere to the required visits and investigations.
Exclusion Criteria:
'Mama' sub-study:
* Any significant health condition which would cause inability to comply with protocol based on investigator discretion.
* History of lung transplantation
'Mini' sub-study:
* Legal guardians' inability to provide consent to participate in the study.
* Mother of infant has significant comorbidities unrelated to CF which could affect infant outcomes based on investigator discretion.
'Midi' sub-study:
* Legal guardians' inability to provide consent to participate in the study.
* A significant health condition which is known to affect lung function or imaging based on investigator discretion
Locations (1)
Royal Brompton Hospital
London, United Kingdom