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New study tracks health of moms with CF and their infants

NCT ID NCT06797206

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 60 women with cystic fibrosis (CF) who are planning a pregnancy, pregnant, or new parents, along with their babies. Researchers will track lung function, nutrition, mental health, and pregnancy outcomes, as well as infant health issues like liver function and lung clearance. The goal is to understand what extra care or screening might be needed for these families.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better clinical guidelines for managing pregnancy and early parenthood in women with cystic fibrosis.
What could go wrong
This is an observational study, not testing a new treatment. It may not produce clear answers due to its small size (60 participants) and single-center design.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

1. Females aged 16 years or older with CF under the care of the Royal Brompton Hospital adult CF Unit who are planning a pregnancy or pregnant. 2. Biological offspring of people with CF (both mothers and fathers) cared for by the Royal Brompton Hospital Adult CF Service, from birth to aged six years.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Royal Brompton Hospital

    RECRUITING

    London, United Kingdom

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