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Balloon in the womb: new hope for babies with underdeveloped lungs?

NCT ID NCT02549820

Disease control Sponsor: Children's Hospital of Philadelphia 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This pilot study tests a procedure called FETO in 14 unborn babies with severe left congenital diaphragmatic hernia (CDH), a birth defect where abdominal organs push into the chest and stunt lung growth. Doctors place a tiny balloon in the baby's windpipe via fetoscopy to trap lung fluid and encourage lung expansion. The goal is to see if the balloon can be safely placed and removed, potentially improving survival after birth.

What this could mean

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

Active substance
GoldBAL2 Detachable Balloon and delivery catheter (fetoscopic endoluminal tracheal occlusion device)
What this could lead to
If successful, this procedure could help babies with severe CDH survive by allowing their lungs to grow before birth.
What could go wrong
This is a very small pilot study (14 participants) testing feasibility, not effectiveness. The procedure carries risks for both mother and fetus, including premature balloon removal or complications from the fetoscopic surgery.

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

14 people

The number who actually took part.

Start date

Jul 2015

Expected to finish

Jul 2027

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: 1. Pregnant women age 18 years and older, who are able to consent 2. Singleton pregnancy Fetal: 3. Normal Karyotype or chromosomal microarray with non-pathologic variants 4. Diagnosis of Isolated Left CDH with liver up 5. Gestation at enrollment prior to 29 weeks plus 5 days 6. SEVERE pulmonary hypoplasia with Ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) \< 25% Exclusion Criteria: 1. Pregnant women \< 18 years 2. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy 3. Technical limitations precluding fetoscopic surgery 4. Rubber latex allergy 5. Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa 6. Psychosocial ineligibility, precluding consent 7. Fetal Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25% 8. Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

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Conditions

The condition(s) this trial relates to.

congenital diaphragmatic hernia pulmonary hypoplasia

As listed by the trial registrant

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

Congenital diaphragmatic hernia Pulmonary hypoplasia

Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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