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 8, 2018
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)|
|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 :||March 2019|
|Estimated Study Completion Date :||July 2019|
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.
- 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.
- 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.
- 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
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
|Contact: Ahmet A Baschat, MD||443 287 9549||abascha1@JHMI.edu|
|Contact: Jena L Miller, MD||443 287 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Ahmet A Baschat, MD||Johns Hopkins University|