Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia - Full Text View

Sponsors and Collaborators:	University Hospital, Bonn University Hospital Mannheim
Information provided by:	University Hospital, Bonn
ClinicalTrials.gov Identifier:	NCT00373438

Purpose

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.

Condition	Intervention	Phase
Diaphragmatic Hernia	Procedure: Fetoscopic tracheal balloon occlusion	Phase II

MedlinePlus related topics: Hernia Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:

Need for postnatal ECMO therapy [ Time Frame: First two days of life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Survival to discharge from hospital [ Time Frame: Days to discharge ] [ Designated as safety issue: No ]
Maternal morbidity [ Time Frame: Until maternal discharge ] [ Designated as safety issue: Yes ]
Fetal / Neonatal morbidity [ Time Frame: Overall & at discharge from hospital ] [ Designated as safety issue: Yes ]
Premature preterm rupture of membranes [ Time Frame: Following the interventions over the remainder of gestation ] [ Designated as safety issue: Yes ]
Unintended preterm delivery [ Time Frame: Following the interventions before scheduled elective delivery ] [ Designated as safety issue: Yes ]
Days in intensive care [ Time Frame: Number of day until discharge from ICU ] [ Designated as safety issue: Yes ]
Days in hospital [ Time Frame: Number of days until discharge from hospital ] [ Designated as safety issue: Yes ]
Oxygen dependency on discharge [ Time Frame: Days until discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	98
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No 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
B: Experimental Fetoscopic tracheal occlusion	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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373438

Contacts

Contact: Thomas Kohl, MD	-49-228-2871-5942	thomas.kohl@ukb.uni-bonn.de
Contact: Thomas Schaible, MD	-49-160-550-1023	t.schaible@t-online.de

Locations

Germany
German Center for Fetal Surgery & Minimally Invasive Therapy	Recruiting
Bonn, Germany, 53105
Contact: Thomas Kohl, MD 0049-175-597-1213 thomas.kohl@ukb.uni-bonn.de
Contact: Thomas Schaible, MD 0049-160-550-1023
Principal Investigator: Thomas Kohl, MD
Principal Investigator: Thomas Schaible, MD

Sponsors and Collaborators

University Hospital, Bonn

University Hospital Mannheim

Investigators

Principal Investigator:	Thomas Kohl, MD	German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany
Principal Investigator:	Thomas Schaible, MD	Neonatal Intensive Care Unit (ECMO center), University of Mannheim, Germany

More Information

Additional Information:

Homepage of the German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	German Center for Fetal Surgery & Minimally-Invasive Therapy ( Thomas Kohl MD )
Study ID Numbers:	FDH-ECMO/BALLOON-TRIAL-135/06, 135/06
Study First Received:	September 6, 2006
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00373438 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital, Bonn:

Congenital diaphragmatic hernia
tracheal occlusion
fetus

fetal surgery
fetoscopy
ECMO

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Congenital Diaphragmatic Hernia
Hernia

Hernia, Diaphragmatic
Disease Progression
Anesthetics

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hernia
Hernia, Diaphragmatic

ClinicalTrials.gov processed this record on May 06, 2009