Congenital Diaphragmatic Hernia Clinical Trial
— CHOP_FETOOfficial title:
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
NCT number | NCT02549820 |
Other study ID # | 15-011714 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | December 2025 |
CDH is a birth defect characterized by the development, very early in gestation, of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. Pregnant women age 18 years and older, who are able to consent 2. Singleton pregnancy Fetal: 3. Normal Karyotype or chromosomal microarray with non-pathologic variants 4. Diagnosis of Isolated Left CDH with liver up 5. Gestation at enrollment prior to 29 weeks plus 5 days 6. SEVERE pulmonary hypoplasia with Ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) < 25% Exclusion Criteria: 1. Pregnant women < 18 years 2. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy 3. Technical limitations precluding fetoscopic surgery 4. Rubber latex allergy 5. 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 6. Psychosocial ineligibility, precluding consent 7. Fetal Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR = 25% 8. Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia |
United States,
Danzer E, Hedrick HL. Controversies in the management of severe congenital diaphragmatic hernia. Semin Fetal Neonatal Med. 2014 Dec;19(6):376-84. doi: 10.1016/j.siny.2014.10.001. Epub 2014 Nov 7. — View Citation
Deprest J, Brady P, Nicolaides K, Benachi A, Berg C, Vermeesch J, Gardener G, Gratacos E. Prenatal management of the fetus with isolated congenital diaphragmatic hernia in the era of the TOTAL trial. Semin Fetal Neonatal Med. 2014 Dec;19(6):338-48. doi: 10.1016/j.siny.2014.09.006. Epub 2014 Nov 11. — View Citation
Deprest J, Nicolaides K, Done' E, Lewi P, Barki G, Largen E, DeKoninck P, Sandaite I, Ville Y, Benachi A, Jani J, Amat-Roldan I, Gratacos E. Technical aspects of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia. J Pediatr Surg. 2011 Jan;46(1):22-32. doi: 10.1016/j.jpedsurg.2010.10.008. — View Citation
Deprest JA, Gratacos E, Nicolaides K, Done E, Van Mieghem T, Gucciardo L, Claus F, Debeer A, Allegaert K, Reiss I, Tibboel D. Changing perspectives on the perinatal management of isolated congenital diaphragmatic hernia in Europe. Clin Perinatol. 2009 Jun;36(2):329-47, ix. doi: 10.1016/j.clp.2009.03.004. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful balloon placement and removal. | Successful balloon placement and removal will be counted per patient. FETO insertion will be attempted up to 3 times in a single pregnant woman/ fetus.
The maximum duration of balloon implantation, if placed at 27 weeks 0 days and removed in the 34th week, is 7 weeks. For those balloons placed later in gestation or removed earlier electively or emergently, the duration will be shorter. |
7 weeks |
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