Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

NCT ID: NCT00373438

Last Updated: 2009-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-07-31

Brief 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.

Conditions

Diaphragmatic Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: NO_INTERVENTION

Fetoscopic tracheal balloon occlusion

Intervention Type: PROCEDURE

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

Fetoscopic tracheal occlusion

Group Type: EXPERIMENTAL

Fetoscopic tracheal balloon occlusion

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universitätsmedizin Mannheim

OTHER

Sponsor Role: collaborator

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

German Center for Fetal Surgery & Minimally-Invasive Therapy

Principal Investigators

Thomas Kohl, MD

Role: PRINCIPAL_INVESTIGATOR

German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany

Thomas Schaible, MD

Role: PRINCIPAL_INVESTIGATOR

Neonatal Intensive Care Unit (ECMO center), University of Mannheim, Germany

Locations

German Center for Fetal Surgery & Minimally Invasive Therapy

Bonn, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Thomas Kohl, MD

Role: CONTACT

thomas.kohl@ukb.uni-bonn.de

-49-228-2871-5942

Thomas Schaible, MD

Role: CONTACT

t.schaible@t-online.de

-49-160-550-1023

Facility Contacts

Thomas Kohl, MD

Role: primary

thomas.kohl@ukb.uni-bonn.de

0049-175-597-1213

Thomas Schaible, MD

Role: backup

0049-160-550-1023

References

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. doi: 10.1159/000091363.

Reference Type: BACKGROUND

PMID: 16601345 (View on PubMed)

Other Identifiers

135/06

Identifier Type: -

Identifier Source: secondary_id

FDH-ECMO/BALLOON-TRIAL-135/06

Identifier Type: -

Identifier Source: org_study_id