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Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia (FETO)

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ClinicalTrials.gov Identifier: NCT02596802
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Anthony Johnson, The University of Texas Health Science Center, Houston

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
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 : December 1, 2015
Actual Primary Completion Date : September 5, 2017
Actual Study Completion Date : October 5, 2018


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




Primary Outcome Measures :
  1. Successful placement of Balt Goldbal2 balloon [ Time Frame: 7 weeks after placement ]
  2. Successful removal of Balt Goldbal2 balloon [ Time Frame: within 5 weeks prior to delivery ]
  3. Gestational age at delivery [ Time Frame: at delivery ]

Secondary Outcome Measures :
  1. Lung volume [ Time Frame: 7 weeks after placement of balloon ]
  2. Lung head ratio [ Time Frame: 7 weeks after placement of balloon ]
  3. Survival at 30 days [ Time Frame: 30 days post delivery ]

Other Outcome Measures:
  1. Maternal complications [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  6. 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.
  7. 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.
  8. Patient meets psychosocial criteria
  9. 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.
  6. 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]
  7. 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
  8. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
  9. History of incompetent cervix with or without cerclage
  10. Placental abnormalities (previa, abruption, accrete) known at time of enrollment
  11. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
  12. 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
  13. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
  14. There is no safe or technically feasible fetoscopic approach to balloon placement
  15. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596802


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Anthony Johnson, DO The University of Texas Health Science Center, Houston

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Responsible Party: Anthony Johnson, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02596802     History of Changes
Other Study ID Numbers: HSC-MS-15-0796
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Keywords provided by Anthony Johnson, The University of Texas Health Science Center, Houston:
Fetoscopic Endoluminal Tracheal Occlusion
Congenital Diaphragmatic Hernia

Additional relevant MeSH terms:
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Hernia
Hernia, Diaphragmatic
Hernias, Diaphragmatic, Congenital
Pathological Conditions, Anatomical
Congenital Abnormalities