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Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

This study is currently recruiting participants.
Verified January 2009 by University Hospital, Bonn
Sponsor:
Collaborator:
University Hospital Mannheim
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00373438
First received: September 6, 2006
Last updated: January 5, 2009
Last verified: January 2009
History of Changes
  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 2

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

Resource links provided by NLM:

U.S. FDA Resources

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
No Intervention: A 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
Experimental: B
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

Publications:

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

Keywords provided by University Hospital, Bonn:
Congenital diaphragmatic hernia
tracheal occlusion
fetus
 fetal surgery
fetoscopy
ECMO

Additional relevant MeSH terms:
Hernia
Hernia, Diaphragmatic
Hernia, Hiatal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013