Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia

• Sponsor: Anthony Johnson (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02596802
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Diaphragmatic Hernia	Device: FETO therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
• Actual Study Start Date: Dec 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FETO therapy Intervention name: FETO therapy	Device: FETO therapy; Fetoscopic surgery at 27 to 31 weeks and 6 days gestation.

Outcome Measures

Primary Outcome Measures

1. Successful placement of Balt Goldbal2 balloon [7 weeks after placement]

2. Successful removal of Balt Goldbal2 balloon [within 5 weeks prior to delivery]

3. Gestational age at delivery [at delivery]

Secondary Outcome Measures

1. Lung volume [7 weeks after placement of balloon]

2. Lung head ratio [7 weeks after placement of balloon]

3. Survival at 30 days [30 days post delivery]

Other Outcome Measures

1. Maternal complications [After Insertion of Balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)]

   Maternal complications include preterm labor, premature preterm rupture of membranes, oligohydramnios, polyhydramnios, and chorioamnionitis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Pregnant women age 18 years and older

2. Singleton pregnancy

3. Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks

4. Isolated Left CDH with liver up

5. LHR < 25% - Gestation age at enrollment prior to 29 wks plus 6 days; O/E LHR 25- <30%

• gestation age at time of enrollment prior to 31 wks plus 6 days

1. SEVERE pulmonary hypoplasia with US O/E LHR < 25% (measured at 18 weeks plus 0 days to 29 weeks plus 5 days) at the time of surgery; O/E LHR 25- <30% (measured at 30 weeks plus 0 days - 31 weeks plus 6 days) at time of surgery.

2. Gestational age at FETO procedure with O/E LHR < 25% at 27 weeks plus 0 days to 29 weeks plus 6 days; O/E LHR 25- <30% at FETO procedure at 30 weeks plus 0 days - 31 weeks plus 6 days as determined by clinical information (LMP) and evaluation of first ultrasound.

3. Patient meets psychosocial criteria

4. Informed consent

Exclusion Criteria:

1. Patient < 18 years of age

2. Multi-fetal pregnancy

3. History of natural rubber latex allergy

4. 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

5. 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.

1. 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]

2. 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

3. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy

4. History of incompetent cervix with or without cerclage

5. Placental abnormalities (previa, abruption, accrete) known at time of enrollment

6. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy

7. 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

8. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality

9. There is no safe or technically feasible fetoscopic approach to balloon placement

10. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• Anthony Johnson

Investigators

• Principal Investigator: Anthony Johnson, DO, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anthony Johnson, Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT02596802
• Other Study ID Numbers: HSC-MS-15-0796
• First Posted: Nov 4, 2015
• Last Update Posted: Jul 5, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Anthony Johnson, Professor, The University of Texas Health Science Center, Houston: Fetoscopic Endoluminal Tracheal Occlusion; Congenital Diaphragmatic Hernia
• Additional relevant MeSH terms: Hernias, Diaphragmatic, Congenital; Hernia; Hernia, Diaphragmatic

Study Results

No Results Posted as of Jul 5, 2022