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

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Balloon in the womb may save babies with rare birth defect

NCT ID NCT00881660

Disease control Sponsor: Michael A Belfort Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a procedure called FETO (fetal endotracheal occlusion) in 20 pregnant women whose babies had a severe form of congenital diaphragmatic hernia (CDH). In CDH, a hole in the diaphragm allows abdominal organs to move into the chest, preventing the lungs from growing normally. The procedure involves placing a small balloon in the baby's windpipe to block it temporarily, which helps the lungs expand and develop. The balloon is removed before birth. The main goal was to see if the procedure could improve survival to two years of age.

What this could mean

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

Active substance
Goldballoon Detachable Balloon and delivery microcatheter
What this could lead to
If successful, FETO could improve survival rates for babies born with severe congenital diaphragmatic hernia by allowing their lungs to develop before birth.
What could go wrong
This was a small pilot study with only 20 participants, so results may not apply to all cases. The procedure carries risks for both mother and fetus, including premature delivery or complications from balloon placement.

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

20 people

The number who actually took part.

Started

Feb 2012

Finished

Apr 2023

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 45 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: * Patient is a pregnant woman between 18 and 45 years of age * Singleton pregnancy * Confirmed diagnosis of severe or extremely severe left, right or bilateral CDH of the fetus Severe CDH: -Fetal liver herniated into the hemithorax -Lung-head ratio (LHR) is less than or equal to 1.0 calculated between 27+0/7 and 29+6/7 weeks' gestation Extremely Severe CDH: -At least 1/3rd of the liver parenchyma herniated into the thoracic cavity -Lung-head ratio (LHR) is \< 0.71 calculated between 22+0/7 and 29+6/7 weeks' gestation * Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome * Normal fetal karyotype * The mother must be healthy enough to have surgery * Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure * Patient willing to remain in Houston for the duration following the balloon placement until delivery * Signed informed consent EXCLUSION CRITERIA: * Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia * Allergy to latex * Allergy or previous adverse reaction to a study medication specified in this protocol * Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) * Fetal aneuploidy, known structural genomic variants, other major fetal anomalies, or known syndromic mutation * Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI * Maternal BMI \>40 * High risk for fetal hemophilia

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.

congenital diaphragmatic hernia

As listed by the trial registrant

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

Congenital diaphragmatic hernia

Contacts and locations

Locations

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

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