Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia

Congenital Diaphragmatic Hernia Clinical Trial

— FETO  

Official title:

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02596802
• Other study ID #: HSC-MS-15-0796
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Anthony Johnson, DO
• Phone: 832 325-7288
• Email: Anthony.Johnson[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal is to assess the feasibility and safety of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia (CDH) at UTHealth. UTHealth's success in this study (with an initial 5 patients) will determine the feasibility of UTHealth's future participation in multi-center trials of this intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant women age 18 years and older
• Singleton pregnancy
• Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
• Isolated Left CDH with liver up
• O/E LHR < 30% - Gestation age at time of enrollment prior to 29 wks plus 5 days as determined by clinical information (LMP, 1st or 2nd trimester ultrasound) and evaluation of first ultrasound (measured at 270 to 296 weeks) at the time of surgery
• Gestational age at FETO procedure with O/E LHR < 30% at 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
• Patient meets psychosocial criteria
• Informed consent

Exclusion Criteria:

• Patient < 18 years of age
• Multi-fetal pregnancy
• History of natural rubber latex allergy
• 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
• Psychosocial ineligibility, precluding consent: Inability to reside within 30 minutes of The Fetal Center at Children's Memorial Hermann Hospital. and inability to comply with the travel for the follow-up requirements of the trial; Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at The Fetal Center at Children's Memorial Hermann Hospital.
• Right sided CDH or bilateral CDH, isolated left sided with O/E LHR =25% (measured at 18 weeks 0 days to 29 weeks 5 days) as determined by ultrasound[1]
• Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring
• Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
• History of incompetent cervix with or without cerclage
• Placental abnormalities (previa, abruption, accrete) known at time of enrollment
• Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
• Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
• Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
• There is no safe or technically feasible fetoscopic approach to balloon placement
• Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

Intervention

Device:
• FETO therapy
Fetoscopic surgery at 27 to 31 weeks and 6 days gestation.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Anthony Johnson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal complications	Maternal complications include preterm labor, premature preterm rupture of membranes, oligohydramnios, polyhydramnios, and chorioamnionitis.	After Insertion of Balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)
Primary	Successful placement of Balt Goldbal2 balloon		7 weeks after placement
Primary	Successful removal of Balt Goldbal2 balloon		within 5 weeks prior to delivery
Primary	Gestational age at delivery		at delivery
Secondary	Lung volume		7 weeks after placement of balloon
Secondary	Lung head ratio		7 weeks after placement of balloon
Secondary	Survival at 30 days		30 days post delivery