NCT06797206 A Study of Females With CF Throughout Pregnancy and Post-partum, and Follow up of Their Offspring
| NCT ID | NCT06797206 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Brompton & Harefield NHS Foundation Trust |
| Condition | Cystic Fibrosis (CF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-06-12 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Imogen Felton
PRINCIPAL INVESTIGATOR
Royal Brompton Hospital and NHLI Imperial College London
Frequently Asked Questions
Who can join the NCT06797206 clinical trial?
This trial is open to participants of all sexes, studying Cystic Fibrosis (CF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06797206 currently recruiting?
Yes, NCT06797206 is actively recruiting participants. Contact the research team at a.downes@imperial.ac.uk for enrollment information.
Where is the NCT06797206 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06797206 clinical trial?
NCT06797206 is sponsored by Royal Brompton & Harefield NHS Foundation Trust. The principal investigator is Imogen Felton at Royal Brompton Hospital and NHLI Imperial College London. The trial plans to enroll 60 participants.