Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yair Blumenfeld
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing a procedure where a small balloon is placed in an unborn baby's windpipe to help their lungs grow better. It targets babies with a serious condition called severe congenital diaphragmatic hernia (CDH). The balloon helps by blocking the windpipe, which makes the lungs expand and develop more before birth.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Fetal Endoscopic Tracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia?
Research indicates that FETO, which involves temporarily blocking the trachea (windpipe) of a fetus, can increase survival rates and reduce complications in babies with severe congenital diaphragmatic hernia (a birth defect affecting the diaphragm). The procedure has been shown to promote lung growth and improve outcomes compared to similar cases without the treatment.
12345How is the FETO Goldballoon treatment different from other treatments for congenital diaphragmatic hernia?
The FETO Goldballoon treatment is unique because it involves a minimally invasive procedure where a balloon is placed endoscopically in the fetus's trachea to promote lung growth, which is not a feature of standard postnatal care for congenital diaphragmatic hernia.
12678Eligibility Criteria
This trial is for pregnant women aged 18-50 with a single fetus diagnosed with severe congenital diaphragmatic hernia (CDH). They must stay near LPCH Stanford, plan to deliver there, and have normal genetic testing results. Excluded are those with latex allergies, certain CDH measurements, placental abnormalities, maternal infections like HIV or Hepatitis B/C, high risk of preterm labor/delivery, significant obesity (BMI >40), or involvement in another study affecting outcomes.Participant Groups
The FETO Goldballoon procedure by Balt medical is being tested for its effectiveness in treating severe CDH in fetuses. The balloon will be inserted endoscopically into the fetal trachea at LPCH Stanford which has specialized maternal-fetal medicine and neonatal services including ECMO and pediatric surgery.
1Treatment groups
Experimental Treatment
Group I: Fetal Endoscopic Tracheal Occlusion (FETO)Experimental Treatment1 Intervention
FETO is performed in-utero and the balloon is removed prior to delivery, and children will have follow-up visits until the age of 2
Balt Goldballoon is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as FETO Goldballoon for:
- Severe Congenital Diaphragmatic Hernia (CDH)
🇺🇸 Approved in United States as FETO Goldballoon for:
- Investigational use for Severe Congenital Diaphragmatic Hernia (CDH)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Lucile Packard Children's HospitalStanford, CA
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Who is running the clinical trial?
Yair BlumenfeldLead Sponsor
References
Simulation training for urgent postnatal fetal tracheal balloon removal: Two learning methods. [2023]In fetuses with severe congenital diaphragmatic hernia, fetal endoluminal tracheal occlusion (FETO) with balloon increases survival and reduces morbidity. Balloon removal is often scheduled electively. In urgent cases, in-utero removal is impossible and removal immediately after delivery has to occur, posing risk of death from airway obstruction. Medical staff need training in urgent removal. Ideal training method is unclear; thus, we compared the performance of two groups trained by different methods.
Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. [2022]To examine operative and perinatal aspects of fetal endoscopic tracheal occlusion (FETO) in congenital diaphragmatic hernia (CDH).
Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. [2020]To present the feasibility, safety and outcomes of fetoscopic endoluminal tracheal occlusion (FETO) for the treatment of severe congenital diaphragmatic hernia (CDH).
Impact of fetal intervention on postnatal management of congenital diaphragmatic hernia. [2014]We report our experience in the postnatal management of congenital diaphragmatic hernia (CDH) after fetal endoluminal balloon tracheal occlusion (FETO).
Technical aspects of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia. [2016]In isolated congenital diaphragmatic hernia, prenatal prediction is made based on measurements of lung size and the presence of liver herniation into the thorax. A subset of fetuses likely to die in the postnatal period is eligible for fetal intervention that can promote lung growth. Rather than anatomical repair, this is now attempted by temporary fetal endoscopic tracheal occlusion (FETO). Herein we describe purpose-designed instruments that were developed thanks to a grant from the European Commission. The feasibility and safety of FETO have now been demonstrated in several active fetal surgery programs. The most frequent complication of the procedure is preterm premature rupture of the membranes, which is probably iatrogenic in nature. It does have an impact on gestational age at delivery and complicates balloon removal. FETO is associated with an apparent increase in survival compared with same severity controls, although this needs to be evaluated in a formal trial. The time has come to do so.
Tracheal obstruction in experimental diaphragmatic hernia: an endoscopic approach in the fetal lamb. [2014]Congenital diaphragmatic hernia (CDH) is associated with a neonatal mortality of up to 50 per cent resulting from pulmonary hypoplasia. Experimental ligation of the trachea increases pulmonary growth in fetuses with experimental diaphragmatic hernia (EDH). To provide a potentially reversible tracheal occlusion (TO) using a minimally invasive procedure, we designed the endoscopic placement of a latex tracheal balloon in fetal lambs with EDH. Following surgical creation of a left EDH at 85 days' gestation, endoscopic occlusion of the fetal trachea was performed at 120 days. The fetuses were retrieved at 139 days. The procedure was successful in 5/11 attempts, resulting in liveborns in which the balloon occluded the trachea completely with expanded lungs and reduction of the herniated viscera into the abdomen. These cases were compared with five cases of EDH without TO and six controls. In the TO group, the lung weight was significantly greater but the radial alveolar count, DNA content, and protein content were similar to normal controls. All lung growth parameters were greater in the TO than in the EDH group. Occlusion of the trachea using an endoscopic technique could provide a useful alternative to open fetal surgery in fetuses with CDH.
A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. [2022]Experimental and clinical data suggest that fetal endoscopic tracheal occlusion to induce lung growth may improve the outcome of severe congenital diaphragmatic hernia. We performed a randomized, controlled trial comparing fetal tracheal occlusion with standard postnatal care.
Comparison between fetal endoscopic tracheal occlusion using a 1.0-mm fetoscope and prenatal expectant management in severe congenital diaphragmatic hernia. [2016]To evaluate if fetal endoscopic tracheal occlusion (FETO) for severe congenital diaphragmatic hernia (CDH) using a 1.0-mm fetoscope improves neonatal outcome.