Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

Diaphragmatic Hernia Clinical Trial

Official title:

Randomized Clinical Trial in Order to Assess the Effect of Fetoscopic Tracheal Balloon Occlusion on the Postnatal Disease Course in Neonates With Left Congenital Diaphragmatic Hernia - FDH-ECMO/BALLOON-TRIAL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00373438
• Other study ID #: FDH-ECMO/BALLOON-TRIAL-135/06
• Secondary ID: 135/06
• Status: Recruiting
• Phase: Phase 2
• First received: September 6, 2006
• Last updated: January 5, 2009
• Start date: January 2009
• Est. completion date: July 2014

Study information

• Verified date: January 2009
• Source: University Hospital, Bonn
• Contact: Thomas Kohl, MD
• Phone: -49-228-2871-5942
• Email: thomas.kohl[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants.

Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls.

Therefore, the purpose of this randomized clinical trial in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: July 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant women from European countries carrying fetuses with left diaphragmatic hernia.

• Normal karyotype, no further severe anomalies on prenatal ultrasound study.

• Fetal liver herniation into the chest; gestational age-related lung volume between 20-25% of normal as determined by magnetic resonance imaging between 30+0 - 34+0 weeks+days of gestation.

Exclusion Criteria:

• Any maternal disease or condition that would result in an increased risk to her health from the experimental procedure.

• Abnormal fetal karyotype, further severe fetal anomalies on prenatal ultrasound.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic

Intervention

Procedure:
• Fetoscopic tracheal balloon occlusion
Maternal local anesthesia, percutaneous ultrasound-guided fetal analgo-sedation and relaxation, percutaneous ultrasound-guided access into amniotic cavity with trocar, fetoscopic tracheal ballon occlusion, removal of fetoscope and trocar, maternal abdominal closure, skin-to-skin time 30 minutes

Locations

Country	Name	City	State
Germany	German Center for Fetal Surgery & Minimally Invasive Therapy	Bonn

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kohl T, Gembruch U, Filsinger B, Hering R, Bruhn J, Tchatcheva K, Aryee S, Franz A, Heep A, Muller A, Bartmann P, Loff S, Hosie S, Neff W, Schaible T; German Center for Fetal Surgery Diaphragmatic Hernia Task Group. Encouraging early clinical experience with deliberately delayed temporary fetoscopic tracheal occlusion for the prenatal treatment of life-threatening right and left congenital diaphragmatic hernias. Fetal Diagn Ther. 2006;21(3):314-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for postnatal ECMO therapy		First two days of life	Yes
Secondary	Survival to discharge from hospital		Days to discharge	No
Secondary	Maternal morbidity		Until maternal discharge	Yes
Secondary	Fetal / Neonatal morbidity		Overall & at discharge from hospital	Yes
Secondary	Premature preterm rupture of membranes		Following the interventions over the remainder of gestation	Yes
Secondary	Unintended preterm delivery		Following the interventions before scheduled elective delivery	Yes
Secondary	Days in intensive care		Number of day until discharge from ICU	Yes
Secondary	Days in hospital		Number of days until discharge from hospital	Yes
Secondary	Oxygen dependency on discharge		Days until discharge	Yes