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Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia
This study is currently recruiting participants.
Study NCT00373438   Information provided by University Hospital, Bonn
First Received: September 6, 2006   Last Updated: January 5, 2009   History of Changes

September 6, 2006
January 5, 2009
January 2009
January 2014   (final data collection date for primary outcome measure)
Need for postnatal ECMO therapy [ Time Frame: First two days of life ] [ Designated as safety issue: Yes ]
Need for postnatal ECMO therapy
Complete list of historical versions of study NCT00373438 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Survival to discharge from hospital
  • Maternal morbidity
  • Fetal morbidity
  • Premature preterm rupture of membranes
  • Unintended preterm delivery
  • Days in intensive care
  • Days in hospital
  • Oxygen dependency on discharge
 
Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia
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

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.

 
Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Diaphragmatic Hernia
Procedure: Fetoscopic tracheal balloon occlusion
Experimental: Fetoscopic tracheal occlusion
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
98
July 2014
January 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years to 50 Years
Yes
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
Germany
 
NCT00373438
Thomas Kohl MD, German Center for Fetal Surgery & Minimally-Invasive Therapy
FDH-ECMO/BALLOON-TRIAL-135/06, 135/06
University Hospital, Bonn
University Hospital Mannheim
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
University Hospital, Bonn
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP