Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Balloon in the womb: new hope for babies with rare birth defect?

NCT ID NCT06946576

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase III trial tests a procedure called FETO for severe congenital diaphragmatic hernia (CDH), where the diaphragm is incomplete and organs move into the chest. Doctors place a temporary balloon in the baby's windpipe before birth to help the lungs grow. The study will compare survival and long-term health of 80 babies who get FETO versus those who receive standard care.

What this could mean

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

Active substance
Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure with a detachable balloon
What this could lead to
If successful, this procedure could significantly increase survival rates for babies with severe congenital diaphragmatic hernia, offering a new treatment option before birth.
What could go wrong
This is an invasive fetal procedure with risks of complications for both mother and baby. The trial is still recruiting, and long-term outcomes are not yet known.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Apr 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 years and older

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: * Pregnant person age 18 years or older * Singleton pregnancy * Normal fetal karyotype with confirmation by culture results, Chromosomal Microarray (CMA) with non-pathological variants, Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS). Results by florescence in situ hybridization (FISH) will be acceptable if the patient is \>26 weeks gestation * Gestational age at enrollment less than 29 weeks 6 days * Intrathoracic liver herniation * Isolated left Congenital Diaphragmatic Hernia (CDH) with Lung to Head Circumference Ratio (LHR) \<30% at enrollment OR isolated right CDH with LHR \<= 45% at enrollment * Cervical length by transvaginal ultrasound \>= 20 mm within 24 hours of FETO procedure * Psychosocial criteria * Able to provide informed consent Exclusion Criteria: * Patient \< 18 years of age * Multi-fetal pregnancy * History of natural rubber latex allergy * Preterm labor, cervix shortened (\<20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor or placenta previa * Psychosocial ineligibility precluding consent * Inability to reside within 30 minutes of OHSU * Inability to comply with the travel for the follow-up requirements of the trial * Lack of a support person (e.g., spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at OHSU. * Bilateral CDH, isolated left sided CDL with LHR \>= 30% or isolated right side CDH with LHR \>45% as determined by ultrasound * No intrathoracic liver herniation * Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e. congenital heart disease) or presence of an underlying genetic syndrome (i.e. Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy * History of incompetent cervix with or without cerclage * Placental abnormalities (previa, abruption, accreta) known at time of enrollment * Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy * Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment * Uterine anomaly such as large or multiple fibroids or Mullerian duct abnormality * No safe or technically feasible fetoscopic approach to balloon placement * Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Congenital diaphragmatic hernia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

More trials for these conditions

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