Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)

NCT02710968 | Active Not Recruiting DMC

• 1 other identifier: IRB00054901
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with congenital diaphragmatic hernia (CDH) remain high. The survival relates to the degree of prenatal lung compression and the subsequent impairment of pulmonary function following delivery. Prenatal assessment by ultrasound or magnetic resonance imaging allows to estimate the severity by relating the circumference of the lung contralateral to the hernia to the fetal head circumference lung to head ratio (LHR) and by noting the degree of upward herniation of the liver. Based on the observed to expected lung to head ratio (O/E LHR), prenatally diagnosed congenital diaphragmatic hernia can be prognostically assessed. While overall survival of congenital diaphragmatic hernia is approximately 60%, an O/E LHR \<25% is associated with survival between 11-24%. The rationale for fetal therapy in severe congenital diaphragmatic hernia is to restore adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed intrauterine endoscopic techniques (fetoscopy) to position and remove endoluminal tracheal balloons in utero (fetoscopic endotracheal occlusion = FETO). Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%. We hypothesize that FETO can be performed and may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe CDH in the most severe group of fetuses with left CDH (O/E LHR \< 30%). FETO therapy will be considered in two subgroups: those with and O/E LHR \<25% (severe group) and those with an O/E between 25 to \<30% (less severe group).

Conditions

Congenital Diaphragmatic Hernia

Keywords

FETO

Outcome Measures

Primary Outcomes (1)

• Successful balloon insertion and removal

  The feasibility of performing the procedure, managing the pregnancy during the period of tracheal occlusion, and removal of the device prior to delivery at Johns Hopkins Hospital.

  4 to 7 weeks

Secondary Outcomes (2)

• Survival

  28 days after delivery

• Percentage of lung growth

  4 to 7 weeks

Study Arms (1)

11540KE and Balt Goldbal 2 balloon

EXPERIMENTAL

Patients meeting inclusion criteria will receive fetoscopic tracheal occlusion using the fetoscopy sheath 11540 KE and the Balt Goldbal2 detachable balloon. Participants with an O/E LHR \<25% (severe group) will have FETO completed at 27 weeks + 0 days to 29 weeks + 6 days gestation. Balloon removal is 4-5 weeks after that. Participants with an O/E LHR 25 to \<30% (less severe group) will have FETO completed at 30 weeks + 0 days to 31 weeks + 6 days gestation. Balloon removal is 3 - 4 weeks after that.

Device: 11540KE and Balt Goldbal 2 balloon

Interventions

11540KE and Balt Goldbal 2 balloon DEVICE

Fetoscopic tracheal occlusion will be performed using above devices and reversed after 4-5 weeks.

Also known as: Karl Storz 11540 KE fetoscopy sheath, BALT GOLDBAL2 1.5 mm detachable balloon, BALT COAX delivery catheter (BALTACCIBDPE100)

11540KE and Balt Goldbal 2 balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women age 18 years and older, who are able to consent.
• Singleton pregnancy.
• Anatomically and chromosomally normal fetus.
• Left sided diaphragmatic hernia with liver up.
• SEVERE pulmonary hypoplasia with O/E LHR \< 30%.
• In patients with O/E LHR 25% to \<30%, enrollment prior to gestational age 30 weeks+0 days to 31 weeks+6 days.
• In patients with O/E LHR \<25%, enrollment prior to gestational age 27 weeks+0 days to 29 weeks+6 days.

You may not qualify if:

• Pregnant women \< 18 years.
• Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy.
• Technical limitations precluding fetoscopic surgery.
• Women with history of natural rubber latex allergy.
• Preterm labor, cervix shortened \<15 mm within 24 hours prior to the FETO balloon insertion or uterine anomaly strongly predisposing to preterm labor, placenta previa.
• Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 30%.

Sponsors & Collaborators

• Johns Hopkins University: lead
• KARL STORZ Endoscopy-America, Inc.: collaborator

Study Sites (1)

Johns Hopkins Center for Fetal Therapy

Baltimore, Maryland, 21287, United States

Location

Related Publications (45)

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  PMID: 32028493 DERIVED

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

• Ahmet A Baschat, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: March 17, 2016
• Study Start: August 1, 2015
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)