Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia

NCT00881660 | Completed DMC FDA Device

• 1 other identifier: H-28021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be accurately diagnosed by mid-gestation, a number of strategies have been developed to repair the hernia and promote lung tissue development. Fetal tracheal occlusion is one technique that temporarily closes the herniated area with the Goldvalve balloon to allow the lungs to develop and increase survival at birth. This is a pilot study of a cohort of fetuses affected by severe CDH that will undergo FETO to demonstrate the feasibility of performing the procedure, managing the pregnancy during the period of tracheal occlusion, and removal of the device prior to delivery at BCM/Texas Children's Hospital (TCH). It is anticipated that fetal tracheal occlusion plug-unplug procedure will improve mortality and morbidity outcomes as compared with current management, but this is not a primary endpoint of the feasibility study. We will perform 20 FETO procedures on fetuses diagnosed prenatally with severe and extremely severe CDH.

Conditions

Congenital Diaphragmatic Hernia

Keywords

Fetal Tracheal Occlusion; congenital diaphragmatic hernia; FETO plug-unplug; Goldvalve balloon; Severe Congenital Diaphragmatic Hernia; Extremely Severe Congenital Diaphragmatic Hernia; Goldbal balloon; FETO

Outcome Measures

Primary Outcomes (1)

• 2-year Survival

  To assess two-year neonatal survival following FETO.

  2 years after childbirth.

Secondary Outcomes (21)

• Successful completion of surgical procedures/balloon placement

  Up to 10 weeks.

• Maternal Outcomes- Maternal Morbidity-incidence of preterm delivery

  Up to 6 weeks postpartum

• Maternal Outcomes- Maternal Morbidity-incidence of cesarean section

  Up to 6 weeks postpartum

• Maternal Outcomes- Maternal Morbidity-length of hospitalization

  Up to 6 weeks postpartum

• Maternal Outcomes- Maternal Morbidity- length of hospitalization after UNPLUG procedure

  Up to 6 weeks postpartum

Study Arms (1)

Fetal Endotracheal Occlusion

EXPERIMENTAL

Placement and retrieval of the GoldBAL4 or GoldBal2 Detachable balloon using the plug/unplug method, using BALTACCIDBPE100 Delivery Catheter.

Device: Goldballoon Detachable Balloon and delivery microcatheter

Interventions

Goldballoon Detachable Balloon and delivery microcatheter DEVICE

Between 27+0/7 - 29+ 6/7 weeks gestation for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as "extremely severe" cases of CDH, placement of the Goldvalve detachable balloon. Balloon retrieval will be planned for between 32+0/7 and 34+6/7 weeks or no longer than 10 weeks after balloon placement at the discretion of the FETO center.

Also known as: GOLDBAL4 or GOLDBAL2 Goldballoon, BALTACCIBDPE100 delivery microcatheter

Fetal Endotracheal Occlusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael A Belfort: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (8)

• Deprest J, Jani J, Gratacos E, Vandecruys H, Naulaers G, Delgado J, Greenough A, Nicolaides K; FETO Task Group. Fetal intervention for congenital diaphragmatic hernia: the European experience. Semin Perinatol. 2005 Apr;29(2):94-103. doi: 10.1053/j.semperi.2005.04.006.

  PMID: 16050527 BACKGROUND

• Deprest J, Jani J, Van Schoubroeck D, Cannie M, Gallot D, Dymarkowski S, Fryns JP, Naulaers G, Gratacos E, Nicolaides K. Current consequences of prenatal diagnosis of congenital diaphragmatic hernia. J Pediatr Surg. 2006 Feb;41(2):423-30. doi: 10.1016/j.jpedsurg.2005.11.036.

  PMID: 16481263 BACKGROUND

• Done E, Gucciardo L, Van Mieghem T, Jani J, Cannie M, Van Schoubroeck D, Devlieger R, Catte LD, Klaritsch P, Mayer S, Beck V, Debeer A, Gratacos E, Nicolaides K, Deprest J. Prenatal diagnosis, prediction of outcome and in utero therapy of isolated congenital diaphragmatic hernia. Prenat Diagn. 2008 Jul;28(7):581-91. doi: 10.1002/pd.2033.

  PMID: 18634116 BACKGROUND

• Saura L, Castanon M, Prat J, Albert A, Caceres F, Moreno J, Gratacos E. Impact of fetal intervention on postnatal management of congenital diaphragmatic hernia. Eur J Pediatr Surg. 2007 Dec;17(6):404-7. doi: 10.1055/s-2007-989275.

  PMID: 18072025 BACKGROUND

• Deprest JA, Hyett JA, Flake AW, Nicolaides K, Gratacos E. Current controversies in prenatal diagnosis 4: Should fetal surgery be done in all cases of severe diaphragmatic hernia? Prenat Diagn. 2009 Jan;29(1):15-9. doi: 10.1002/pd.2108. No abstract available.

  PMID: 19125386 BACKGROUND

• Kohl T, Gembruch U, Tchatcheva K, Schaible T. Current consequences of prenatal diagnosis of congenital diaphragmatic hernia by Deprest et al (J Ped Surg 2006;41:423-30). J Pediatr Surg. 2006 Jul;41(7):1344-5; author reply 1345-6. doi: 10.1016/j.jpedsurg.2006.04.001. No abstract available.

  PMID: 16818078 BACKGROUND

• Harrison MR, Adzick NS, Estes JM, Howell LJ. A prospective study of the outcome for fetuses with diaphragmatic hernia. JAMA. 1994 Feb 2;271(5):382-4.

  PMID: 8054005 BACKGROUND

• Belfort MA, Olutoye OO, Cass DL, Olutoye OA, Cassady CI, Mehollin-Ray AR, Shamshirsaz AA, Cruz SM, Lee TC, Mann DG, Espinoza J, Welty SE, Fernandes CJ, Ruano R. Feasibility and Outcomes of Fetoscopic Tracheal Occlusion for Severe Left Diaphragmatic Hernia. Obstet Gynecol. 2017 Jan;129(1):20-29. doi: 10.1097/AOG.0000000000001749.

  PMID: 27926636 RESULT

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Belfort, MD, PhD

  Baylor College of Medicine - Texas Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman and Professor

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 15, 2009
• Study Start: February 21, 2012
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2023
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)