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Womb balloon therapy aims to save babies with severe lung defect

NCT ID NCT05461222

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a procedure called FETO for babies with a severe birth defect where the diaphragm has a hole, allowing organs to crowd the lungs. A tiny balloon is placed in the baby's windpipe while still in the womb to help the lungs grow. The study tracks how many babies survive to leave the hospital and up to 2 years of age, and monitors safety. It involves 15 pregnant people carrying a single baby with severe CDH.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

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

Started

Apr 2023

Expected to finish

Aug 2030

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.

Ages

18 to 50 years

Sex

Female participants only

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: * Maternal Age: 18-50 * Singleton gestation * Gestational age before 29 weeks 6 days * Severe left or right-sided CDH: For severe left sided CDH observed-to-expected lung-to- head ratio (o/e LHR) less than 25% between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms. For severe right sided CDH o/e LHR less than 30 % between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms. * Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus sampling (CVS) * Absence of associated fetal structural cardiac anomalies by a dedicated fetal echocardiogram * Absence of other structural anomalies by ultrasound or MRI * Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT). * Must be willing to remain near LPCH Stanford (within 30 minutes from the hospital) for the duration of the balloon placement. * No maternal and/or fetal contra-indications to fetal surgery such as a bleeding disorder, poorly controlled diabetes or hypertension, short cervix (measuring \< 20mm), risk for preterm birth etc. * Planned pregnancy surveillance at LPCH Stanford * Planned delivery at LPCH Stanford * Able to provide written consent * Willingness to comply with all study procedures and availability (meets psychosocial criteria) for the duration of the study including having a support person Exclusion Criteria: * Contraindications to fetal surgery including poorly controlled hypertension, diabetes or other maternal medical condition including hematological disorder * High risk for preterm labor and/or delivery based on either significant history of preterm birth, short cervix (measuring \< 20mm), significant uterine anomaly or other risk factor, incompetent cervix (requiring cerclage) * Non-isolated CDH - CDH with additional structural anomalies * Significant maternal obesity defined as a body mass index (BMI) greater than 40. BMI is a calculation which includes a person's height and weight * History of natural rubber latex allergy * Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality * Participation in another intervention study that influences maternal and fetal morbidity and mortality. * Bilateral CDH, left-sided CDH with O/E LHR \>25%, or left-sided CDH with O/E LHR \<25% but liver completely down in abdomen * Right-sided CDH O/E LHR \>30% or right-sided CDH with O/E LHR \<30% with liver completely down in abdomen * Significant placental abnormalities (abruption, chorioangioma, accreta) known at the time of enrollment and/or surgery * Maternal-fetal Rhesus isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia, affecting the current pregnancy. * Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure * No safe or feasible fetoscopic approach to balloon placement.

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

  • Lucile Packard Children's Hospital

    RECRUITING

    Stanford, California, 94305-6070, United States

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.