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

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ClinicalTrials.gov Identifier: NCT02710968
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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%. Our goal with this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH (O/E LHR < 30%). which 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).


Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernia Device: 11540KE and Balt Goldbal 2 balloon Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe Left Congenital Diaphragmatic Hernia (CDH)
Study Start Date : August 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Experimental: 11540KE and Balt Goldbal 2 balloon

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 - <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
Fetoscopic tracheal occlusion will be performed using above devices and reversed after 4-5 weeks.
Other Names:
  • Karl Storz 11540 KE fetoscopy sheath
  • BALT GOLDBAL2 1.5 mm detachable balloon
  • BALT COAX delivery catheter (BALTACCIBDPE100)




Primary Outcome Measures :
  1. Successful balloon insertion and removal [ Time Frame: 4 to 7 weeks ]
    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.


Secondary Outcome Measures :
  1. Survival [ Time Frame: 28 days after delivery ]
    The neonatal survival of participants receiving FETO expressed as a percentage of the total number of participants undergoing the procedure.

  2. Percentage of lung growth [ Time Frame: 4 to 7 weeks ]
    The percentage of size increase in the contralateral fetal lung as related to the pre-procedure lung size



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Gestation at enrollment prior to 27+0 to 29+6 weeks in patients with O/E LHR of 25% or 30+0 to 31+6 weeks in patients with O/E 25 -<30%.
  • SEVERE pulmonary hypoplasia with O/E LHR < 30%.

Exclusion Criteria:

  • Pregnant women < 18 years.
  • Women with allergy to Latex.
  • Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy.
  • Technical limitations precluding fetoscopic surgery.
  • 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.
  • Psychosocial ineligibility, precluding consent.
  • Maternal depression as assessed by a Beck Depression Inventory score equal to or greater than 17.
  • Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 30%.
  • Inability to remain close to the FETO site during time period of tracheal occlusion.

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): NCT02710968


Contacts
Contact: Ahmet A Baschat, MD 443 287 9549 abascha1@JHMI.edu
Contact: Jena L Miller, MD 443 287 9549 jmill260@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Center for Fetal Therapy Recruiting
Baltimore, Maryland, United States, 21287
Contact: Ahmet A Baschat, MD    443-287-9548    abascha1@JHMI.edu   
Contact: Cassandra Delp    443 287 9548    cdelp1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Ahmet A Baschat, MD Johns Hopkins University

Publications of Results:

Other Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02710968     History of Changes
Other Study ID Numbers: IRB00054901
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Johns Hopkins University:
FETO

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