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Despite advances in prenatal diagnosis and postnatal therapies, including ECMO (Extracorporeal Membrane Oxygenation), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with severe CDH remain high. The rationale for fetal therapy in severe CDH is to promote 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. The investigator's goal with this pilot study is to study the feasibility of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with left CDH (LHR O/E < 25%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device - FETO | Experimental | Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of balloon using the BALT GOLDBAL2 balloon and BALTACCIBDPE100 catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fetoscopic Endoluminal Tracheal Occlusion Surgery | Device | Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery will be completed at 27 weeks 0 days - 29 weeks 6 days gestation. Fetoscopic removal of the balloon occlusion will be performed at 34 weeks 0 days to 34 weeks 6 days gestation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of effective placements of balloon to occlude trachea via fetoscopy | Number of effective placements of balloon to occlude trachea via fetoscopy by performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) in fetuses with severe left congenital diaphragmatic hernia (CDH), as defined by lung to head ratio (LHR) Observed/Expected < 25% | Between 27 and 29 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of fetal lung growth after FETO as measured by lung volume. | Fetal lung growth as measured by lung volume. | Between 27 and 34 weeks gestation |
| Rate of fetal lung growth after FETO as measured by Lung to head circumference ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katie Archbold, BA | Contact | 415-476-0445 | fetus@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hanmin Lee, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco Fetal Treatment Center | Recruiting | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8263712 | Background | Harrison MR, Adzick NS, Flake AW, Jennings RW, Estes JM, MacGillivray TE, Chueh JT, Goldberg JD, Filly RA, Goldstein RB, et al. Correction of congenital diaphragmatic hernia in utero: VI. Hard-earned lessons. J Pediatr Surg. 1993 Oct;28(10):1411-7; discussion 1417-8. doi: 10.1016/s0022-3468(05)80338-0. | |
| 14614166 | Background |
| Label | URL |
|---|---|
| UCSF Fetal Treatment Center website | View source |
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| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
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|
Fetal lung growth as measured by Lung to head circumference ratio (LHR) measurements.
| Between 27 and 34 weeks gestation |
| Determine survival rate of FETO patients | Survival at 6 months after birth. | 6 months after birth |
| Harrison MR, Keller RL, Hawgood SB, Kitterman JA, Sandberg PL, Farmer DL, Lee H, Filly RA, Farrell JA, Albanese CT. A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. N Engl J Med. 2003 Nov 13;349(20):1916-24. doi: 10.1056/NEJMoa035005. |
| 16769018 | Background | Jani JC, Nicolaides KH, Gratacos E, Vandecruys H, Deprest JA; FETO Task Group. Fetal lung-to-head ratio in the prediction of survival in severe left-sided diaphragmatic hernia treated by fetal endoscopic tracheal occlusion (FETO). Am J Obstet Gynecol. 2006 Dec;195(6):1646-50. doi: 10.1016/j.ajog.2006.04.004. Epub 2006 Jun 12. |
| 6520670 | Background | Adzick NS, Harrison MR, Glick PL, Villa RL, Finkbeiner W. Experimental pulmonary hypoplasia and oligohydramnios: relative contributions of lung fluid and fetal breathing movements. J Pediatr Surg. 1984 Dec;19(6):658-65. doi: 10.1016/s0022-3468(84)80349-8. |
| 7738765 | Background | Bealer JF, Skarsgard ED, Hedrick MH, Meuli M, VanderWall KJ, Flake AW, Adzick NS, Harrison MR. The 'PLUG' odyssey: adventures in experimental fetal tracheal occlusion. J Pediatr Surg. 1995 Feb;30(2):361-4; discussion 364-5. doi: 10.1016/0022-3468(95)90590-1. |
| 19658113 | Background | Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450. |
| 22325377 | Background | Deprest J, De Coppi P. Antenatal management of isolated congenital diaphragmatic hernia today and tomorrow: ongoing collaborative research and development. Journal of Pediatric Surgery Lecture. J Pediatr Surg. 2012 Feb;47(2):282-90. doi: 10.1016/j.jpedsurg.2011.11.020. |
| 8906657 | Background | Harrison MR, Adzick NS, Flake AW, VanderWall KJ, Bealer JF, Howell LJ, Farrell JA, Filly RA, Rosen MA, Sola A, Goldberg JD. Correction of congenital diaphragmatic hernia in utero VIII: Response of the hypoplastic lung to tracheal occlusion. J Pediatr Surg. 1996 Oct;31(10):1339-48. doi: 10.1016/s0022-3468(96)90824-6. |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |