Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH

NCT03980717 | Recruiting DMC FDA Device

• 1 other identifier: H-42958
• Study Type: interventional
• Target: 80
• 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 (FETO), using a fetoscopically delivered and removed balloon device, has been used to temporarily occlude the trachea and increase lung distension in CDH to allow the lungs to develop and has been shown to increase survival at birth. The role of FETO in the resolution of pulmonary hypertension in fetuses with severe left- and right- sided CDH remains unclear. Our recent observation that FETO is associated with a higher proportion of infants who resolve their pulmonary hypertension by the age of 1 year as compared with those who have not had FETO, is based on a retrospective cohort study, which, as with any such design, has some intrinsic limitations. Thus, a prospective cohort study that is appropriately powered to confirm or disprove this encouraging observation is needed. If our preliminary observation is confirmed, resolution of PH by the age of 1 year could be added to the benefits of the FETO procedure in severe left and right-sided CDH cases. The investigators will perform 40 FETO procedures on fetuses diagnosed prenatally with severe right- or left-sided CDH, and outcome data will be compared with that of a control group of severe right- or left-sided CDH who will not undergo the FETO procedure because of medical or social issues. Because the prevalence of left-sided CDH is higher than right-side CDH, the investigators will perform 25 FETO procedures in left sided CDH and 15 in right-sided CDH, and these outcomes will be compared to a cohort of 40 non FETO cases.

Conditions

Congenital Diaphragmatic Hernia

Keywords

Fetal Tracheal Occlusion; FETO plug-unplug; Goldvalve balloon; Severe Congenital Diaphragmatic Hernia; Goldbal balloon; FETO

Outcome Measures

Primary Outcomes (2)

• Resolution of Pulmonary Hypertension - 6 months

  To compare the proportion of fetuses with resolution of PH by the age of 6 months in neonates with severe CDH who underwent the FETO procedure and that of a control group composed of neonates who did not have the FETO procedure.

  by the age of 6 months

• Resolution of Pulmonary Hypertension - 12 months

  To compare the proportion of fetuses with resolution of PH by the age of 12 months in neonates with severe CDH who underwent the FETO procedure and that of a control group composed of neonates who did not have the FETO procedure.

  by the age of 12 months

Secondary Outcomes (22)

• 2-year Survival

  2 years after childbirth

• Number of participants who undergo a 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

Study Arms (2)

Fetal Endotracheal Occlusion (FETO)

EXPERIMENTAL

Placement and retrieval of the GoldBAL4 or GoldBAL2 Detachable balloon using the plug/unplug method, using BALTACCIDBPE100 Delivery Catheter.

Device: Goldbal Detachable Balloon and delivery microcatheter

non-FETO

NO INTERVENTION

The control group will consist of patients who did not undergo the FETO procedure who fit the same fetal inclusion/exclusion criteria as our FETO subjects and will be matched by variables including maternal age, body mass index, gestational age, severity of CDH and site of CDH (left- or right-sided).

Interventions

Goldbal Detachable Balloon and delivery microcatheter DEVICE

Between 28+0/7 - 31+6/7 weeks gestation for severe CDH placement of the detachable balloon. Balloon retrieval will be planned for no later than 36+6/7 weeks at the discretion of the FETO center.

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

Fetal Endotracheal Occlusion (FETO)

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
• The fetuses will be 28+0/7 to 31+6/7 weeks of gestational age
• Confirmed diagnosis of severe left- or right-sided CDH of the fetus: Observed/expected total lung volume equal to or less than 0.32 with more than 21% of liver herniated into the hemithorax. (Ideally calculated between 28+0/7 and 31+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 or microarray
• The mother must be healthy enough to have surgery
• Patient and father of the baby provide signed informed consent that details the maternal and fetal risks involved with the procedure
• Patient willing to remain in Houston for the duration following balloon placement until delivery.

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) in the index pregnancy.
• Fetal aneuploidy, known structural genomic variants, other major fetal anomalies that may impact the fetal/neonatal survival 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 Childrens Hospital

Houston, Texas, 77030, United States

RECRUITING

Related Publications (9)

• 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

• Style CC, Olutoye OO, Belfort MA, Ayres NA, Cruz SM, Lau PE, Shamshirsaz AA, Lee TC, Olutoye OA, Fernandes CJ, Cortes MS, Keswani SG, Espinoza J. Fetal endoscopic tracheal occlusion reduces pulmonary hypertension in severe congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2019 Dec;54(6):752-758. doi: 10.1002/uog.20216. Epub 2019 Nov 4.

  PMID: 30640410 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 BACKGROUND

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

Central Study Contacts

Michael Belfort, MD PhD

CONTACT

832-826-7375; belfort@bcm.edu

Rebecca M Johnson, MS

CONTACT

832-826-7451; rj2@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman and Professor

Model Details: The investigators will perform 40 FETO procedures on fetuses diagnosed prenatally with severe right- or left-sided CDH and outcome data will be compared with that of a control group of severe right- or left-sided CDH who will not undergo the FETO procedure because of medical or social issues. Because the prevalence of left-sided CDH is higher than right-side CDH, the investigators will perform 25 FETO procedures in left sided CDH and 15 in right-sided CDH, whose outcomes will be compared to a cohort of 40 non FETO cases. The control group will consist of patients who fit the same fetal inclusion/exclusion criteria as our FETO subjects, and will be matched by variables including maternal age, body mass index, gestational age, severity of CDH and site of CDH (left- or right-sided).

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 10, 2019
• Study Start: August 9, 2019
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)